Government Buyers Guide for Healthcare
April 2015
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Table of Contents nEWS Siemens Introduces Smart Hearing Aids.............................................................................................................................9 Lockheed Martin and Illumina to Collaborate on Developing Genomics Solutions to Improve Public Health and Wellness................................................................................................................................................11 Healthcare Industry Optimistic Despite Challenges, Says New GE Capital Survey......................................................13 FDA Approves First-of-Kind Device to Treat Obesity.......................................................................................................15 Progress Being Made in Infection Control in U.S. Hospitals; Continued Improvements Needed........................17 UTC Donates $1.5 Million to Create New Family Resource Center at Connecticut Children’s Medical Center...................................................................................................................................................................19 Better, Smarter, Healthier: In Historic Announcement, HHS Sets Clear Goals and Timeline for Shifting Medicare Reimbursementsfrom Volume to Value.........................................................................................21 HHS Proposes Path to Improve HealthTechnology and Transform Care.................................................................23 Cerner Completes Acquisition of Siemens Health Services.......................................................................................................... 25 Kallo Selects IBM Cloud Technology to Help Transform Health Care in Remote Communities..........................27 St. Jude Medical Launches U.S. Study of the Country’s Smallest Pediatric Mechanical Heart Valve...................29 New Affordable Care Act Initiative to Encourage Better Oncology Care.................................................................33 Cerner, Mortara Introduce CareAware Waveform Management.....................................................................................35 NIH-Funded Scientists Create Potential Long- Acting HIV Therapeutic..................................................................37 Booz Allen Hamilton Partners with HITRUST on Series of Cyber Preparedness and Education Town Halls for Healthcare Industry...................................................................................................................................39 Surescripts Leverages Technology to Help Doctors Address Prescription Fraud and Abuse.........................................41 HHS Invests in Enhancing Domestic Preparedness Efforts for Ebola...............................................................................43 3D Systems Debuts Powerful New All-In-One Medical 3D Printer at LMT LAB DAY Chicago.....................................45 New Data from CCN Demonstrate Potential of CT to Transform the Cardiac Care Pathway........................................47 Northeastern University Researchers Find Inhaling Supplemental Oxygen Can Awaken Anti-Tumor Cells................49 Saving Precious Time: Siemens’ New Ultrasound System for Faster Imaging.................................................................51 GE Ventures and Stanford Health Care Launch Digital Health Company.......................................................................53 FDA Approves First Biosimilar Product Zarxio.................................................................................................................55 Concordia Healthcare Corp. to Acquire Covis Pharma Commercial Assets for $1.2 Billion...........................................57 Apple Introduces ResearchKit, Giving Medical Researchers the Tools to Revolutionize Medical Studies.....................59 FDA Approves CPR Devices That May Increase Chance of Surviving Cardiac Arrest....................................................61
Events & TRADE SHoWS Centers for Medicare and Medicaid Services (CMS) CISO Security & Privacy Forum....................................................63 HIMSS15 Annual Conference & Exhibition........................................................................................................................65 2015 Preparedness Summit..................................................................................................................................................67 Military and Government Electronic Health Records & Health Data Interoperability Symposium...............................69 VA Healthcare Summit 2015................................................................................................................................................71 2015 ASCO Annual Meeting................................................................................................................................................73
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Siemens Introduces Smart Hearing Aids January 5, 2015 At the 2015 International CES, Siemens is unveiling smart hearing aids—their latest in wearable hearing technology. The hearing aids can be discreetly controlled via both iPhone® and Android™ devices, with latest models clinically proven to outperform people with normal hearing in background noise. When two hearing aids are worn (the most common case), Siemens’ new smart hearing aids utilize intelligent, two-way wireless communication to zero in on desired speech with pinpoint accuracy. This enables better-than-normal hearing in crowded situations like noisy restaurants and cocktail parties where background chatter has historically been a challenge. “These are not your average hearing aids but rather highly-intelligent wearable devices,” said Scott Davis, CEO Siemens Hearing Instruments. “They automatically detect everyday listening environments such as a noisy room, wind, or while driving a car, and instinctively know what to do.” When paired with Siemens’ new easyTek™ and easyTek™ App, a wearer can control the direction of the hearing aids’ microphones—front, left, right, or behind—to simultaneously enhance speech and suppress background noise. The span of the microphones’ focus can also be controlled via the app, allowing wearers to select a wide range of focus or a very narrow beam. “Some hearing aid wearers also want the flexibility that comes with having control over their listening experience,” added Davis. “We’ve all heard of and can appreciate the benefits of ondemand TV. With these hearing aids, you can turn your iPhone or Android device into a hearing aid control center. We call it on-demand hearing.” While Siemens’ new smart hearing aids pair with virtually any iOS or Android mobile device for a custom-tailored listening experience, a smartphone is not required to make use of the new technology. The hearing aids continuously scan the acoustic environment and activate the most optimal settings for that particular listening situation. For example, if you’re at a noisy family gathering, the smart hearing aids hone in on speech coming from the front while softening speech and noise from other directions. Later, if you’re out walking the dog, they automatically adjust so you can enjoy the sounds of nature. Because both hearing aids are in constant communication and processing sound simultaneously, this creates a high-definition surround sound listening experience, with no manual adjustments required.
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Lockheed Martin and Illumina to Collaborate on Developing Genomics Solutions to Improve Public Health and Wellness January 12, 2015 ROCKVILLE, MD & SAN DIEGO, CA -- Lockheed Martin and Illumina, Inc. today announced a new strategic alliance to collaborate on scalable and affordable genomics solutions to provide personalized health care for national populations. Genomics is the science of studying genomes or DNA. Applied to health care, analyzing a person’s DNA sequence data can provide a better understanding of health risks (such as how susceptible a person is to a particular disease or the person may react to a type of medication), resulting in more precise and proactive medicine. By aggregating genomic data across large populations, public health and wellness officials can more effectively address health concerns, reducing health care costs and improving quality of life. The alliance brings together Illumina’s next-generation genetic sequencing tools with Lockheed Martin’s expertise in large-scale information systems and integration to meet the needs of countries as they begin to integrate genomics into their national health systems. “Genomics is enabling a fundamental transformation of health care,” said Horace Blackman, vice president of Health & Life Sciences for Lockheed Martin’s Information Systems & Global Solutions business. “We envision the advantages of early national adoption for countries across the globe, applying clinical decision support applications that can improve health and health care, and lower national health care costs.” “We look forward to working with Lockheed Martin and global health care leaders as we develop best-in-class solutions to realize the full potential of nation-scale sequencing,” said Jay Flatley, Chief Executive Officer of Illumina. “We are excited about this collaboration, given the breadth and depth of Lockheed Martin’s operations and strategic relationships around the globe.”
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Healthcare Industry Optimistic Despite Challenges, Says New GE Capital Survey January 13, 2015 BETHESDA, MD -- While they acknowledge the challenges facing them, healthcare industry leaders in the U.S. are less concerned about healthcare reform and regulatory oversight than they were one year ago, according to a survey conducted by GE Capital’s Healthcare Financial Services business. Overall, they’re optimistic about the future and are relying on a combination of mergers and acquisitions and organic growth to expand. Forty-three percent of respondents said implementing the Affordable Care Act (ACA) is the greatest challenge facing the healthcare industry in 2015. The second-greatest challenge cited was regulatory oversight, selected by 30 percent. The U.S. economy came in third at 17 percent. Last year, 57 percent of respondents to a similar GE Capital survey said that ACA implementation was their greatest challenge, followed by regulatory oversight (20 percent) and the U.S. economy (13 percent). More than two-thirds (68 percent) of respondents said they expect their business to perform more strongly in 2015 than in 2014. Less than one-third (29 percent) said that it would perform the same and only three percent said that it would be weaker this year. “We agree with the optimism shown by our customers and other healthcare industry leaders about 2015. Though less than last year, implementation of the ACA is still top of mind across the industry,” said Al Aria, senior managing director of GE Capital, Healthcare Financial Services’ corporate finance team. “We look forward to supporting customers as they adapt and grow amidst the changing healthcare landscape.” GE Capital conducted the survey shortly before the large gathering of healthcare professionals in San Francisco (which coincides with J.P. Morgan’s Annual Healthcare Conference, which is being held Jan. 12-15). Respondents were asked about their industry and company outlook for 2015. They included 521 senior executives from healthcare companies representing pharmaceuticals, healthcare IT and medical technology companies, hospitals, healthcare service providers and health systems, as well as other industry participants.
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FDA Approves First-of-Kind Device to Treat Obesity January 14, 2015 The U.S. Food and Drug Administration today approved the Maestro Rechargeable System for certain obese adults, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness. The Maestro Rechargeable System, the first FDA-approved obesity device since 2007, is approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes. BMI, which measures body fat based on an individual’s weight and height, is used to define the obesity categories. According to the Centers for Disease Control and Prevention, more than onethird of all U.S. adults are obese, and people with obesity are at increased risk of heart disease, stroke, type 2 diabetes and certain kinds of cancer. “Obesity and its related medical conditions are major public health problems,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.” The Maestro Rechargeable System consists of a rechargeable electrical pulse generator, wire leads and electrodes implanted surgically into the abdomen. It works by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full. Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown. External controllers allow the patient to charge the device and allow health care professionals to adjust the device’s settings in order to provide optimal therapy with minimal side effects. The safety and effectiveness of the Maestro Rechargeable System were evaluated in a clinical trial that included 233 patients with a BMI of 35 or greater. The weight loss and adverse events of 157 patients who received the active Maestro device (the experimental group) were compared to 76 patients in the control group who received a Maestro electrical pulse generator that was not activated. The study found that after 12 months, the experimental group lost 8.5 percent more of its excess weight than the control group.
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Progress Being Made in Infection Control in U.S. Hospitals; Continued Improvements Needed January 14, 2015 ATLANTA -- Progress has been made in the effort to eliminate infections that commonly threaten hospital patients, including a 46 percent decrease in central line-associated bloodstream infections (CLABSI) between 2008 and 2013, according to a report released today by the Centers for Disease Control and Prevention. However, additional work is needed to continue to improve patient safety. CDC’s Healthcare-Associated Infections (HAI) progress report is a snapshot of how each state and the country are doing in eliminating six infection types that hospitals are required to report to CDC. For the first time, this year’s HAI progress report includes state-specific data about hospital lab-identified methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections and Clostridium difficile (C. difficile) infections (deadly diarrhea). The annual National and State Healthcare-associated Infection Progress Report expands upon and provides an update to previous reports detailing progress toward the goal of eliminating HAIs. The report summarizes data submitted to CDC’s National Healthcare Safety Network (NHSN), the nation’s healthcare-associated infection tracking system, which is used by more than 14,500 health care facilities across all 50 states, Washington, D.C., and Puerto Rico. Healthcare-associated infections are a major, yet often preventable, threat to patient safety. On any given day, approximately one in 25 U.S. patients has at least one infection contracted during the course of their hospital care, demonstrating the need for improved infection control in U.S. healthcare facilities. “Hospitals have made real progress to reduce some types of healthcare-associated infections - it can be done,” said CDC Director Tom Frieden, M.D., M.P.H. “The key is for every hospital to have rigorous infection control programs to protect patients and healthcare workers, and for health care facilities and others to work together to reduce the many types of infections that haven’t decreased enough.” This report focuses on national and state progress in reducing infections occurring within acute care hospitals. Although not covered by the report released today, the majority of C. difficile infections and MRSA infections develop in the community or are diagnosed in healthcare settings other than hospitals. Other recent reports on infections caused by germs such as MRSA and C. difficile suggest that infections in hospitalized patients only account for about one-third of all the healthcare-associated infections.
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UTC Donates $1.5 Million to Create New Family Resource Center at Connecticut Children’s Medical Center January 23, 2015 At a press conference Thursday, United Technologies President and CEO Greg Hayes announced a $1.5 million grant to support the United Technologies Family Resource Center at Connecticut Children’s Medical Center, which will provide critical educational resources and support services to patients and their families. The Hartford, Connecticut-based hospital welcomed the significant support and its leadership team expressed confidence that the new Center will bring hope to families whose youngest members must overcome emotional and physical challenges on their road to recovery. “UTC has a long history of supporting leading institutions in our community and is proud to partner with Connecticut Children’s Medical Center,” Hayes said. “When completed, the Center will serve as a valuable new resource for children, parents and caregivers in our community, and we are honored to support Connecticut Children’s investment in improving patient care.” “For me, the Family Resource Center is a dream come true,” said Hope Feliciano, Connecticut Children’s Family Advisory Board member, who has three children currently receiving care at Connecticut Children’s Medical Center. "Now, because of this contribution, families at the hospital have a place to go to learn, connect with others in the same situation and receive the resources they need to care for their children and their families.” In announcing the grant, Hayes was joined by Geraud Darnis, President and CEO, UTC Building & Industrial Systems, along with Martin Gavin, President and CEO of Connecticut Children’s Medical Center. Gavin noted that there are currently no designated areas for helping families understand their children’s unique medical needs. “The Children’s Medical Center’s mission is to help make the children in Connecticut the healthiest in the country,” Gavin said. “United Technologies’ commitment to the Family Resource Center perfectly aligns with that mission, providing services that can impact the lives of the more than 300,000 patient visitors every year.”
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Better, Smarter, Healthier: In Historic Announcement, HHS Sets Clear Goals and Timeline for Shifting Medicare Reimbursements from Volume to Value January 26, 2015 WASHINGTON, DC -- In a meeting with nearly two dozen leaders representing consumers, insurers, providers, and business leaders, Health and Human Services Secretary Sylvia M. Burwell today announced measurable goals and a timeline to move the Medicare program, and the health care system at large, toward paying providers based on the quality, rather than the quantity of care they give patients. HHS has set a goal of tying 30 percent of traditional, or fee-for-service, Medicare payments to quality or value through alternative payment models, such as Accountable Care Organizations (ACOs) or bundled payment arrangements by the end of 2016, and tying 50 percent of payments to these models by the end of 2018. HHS also set a goal of tying 85 percent of all traditional Medicare payments to quality or value by 2016 and 90 percent by 2018 through programs such as the Hospital Value Based Purchasing and the Hospital Readmissions Reduction Programs. This is the first time in the history of the Medicare program that HHS has set explicit goals for alternative payment models and value-based payments. To make these goals scalable beyond Medicare, Secretary Burwell also announced the creation of a Health Care Payment Learning and Action Network. Through the Learning and Action Network, HHS will work with private payers, employers, consumers, providers, states and state Medicaid programs, and other partners to expand alternative payment models into their programs. HHS will intensify its work with states and private payers to support adoption of alternative payments models through their own aligned work, sometimes even exceeding the goals set for Medicare. The Network will hold its first meeting in March 2015, and more details will be announced in the near future. “Whether you are a patient, a provider, a business, a health plan, or a taxpayer, it is in our common interest to build a health care system that delivers better care, spends health care dollars more wisely and results in healthier people. Today’s announcement is about improving the quality of care we receive when we are sick, while at the same time spending our health care dollars more wisely,” Secretary Burwell said. “We believe these goals can drive transformative change, help us manage and track progress, and create accountability for measurable improvement.”
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HHS Proposes Path to Improve Health Technology and Transform Care January 30, 2015 WASHINGTON, DC -- The Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) today released Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Version 1.0. The draft Roadmap is a proposal to deliver better care and result in healthier people through the safe and secure exchange and use of electronic health information. “HHS is working to achieve a better health care system with healthier patients, but to do that, we need to ensure that information is available both to consumers and their doctors,” said HHS Secretary Sylvia M. Burwell. “Great progress has been made to digitize the care experience, and now it’s time to free up this data so patients and providers can securely access their health information when and where they need it. A successful learning system relies on an interoperable health IT system where information can be collected, shared, and used to improve health, facilitate research, and inform clinical outcomes. This Roadmap explains what we can do over the next three years to get there.” The draft Roadmap builds on the vision paper, Connecting Health and Care for the Nation: A 10Year Vision to Achieve an Interoperable Health IT Infrastructure, issued in June 2014. Months of comment and feedback from hundreds of health and health IT experts from across the nation through ONC advisory group feedback, listening sessions and an online forum aided in the development of the Roadmap. “To realize better care and the vision of a learning health system, we will work together across the public and private sectors to clearly define standards, motivate their use through clear incentives, and establish trust in the health IT ecosystem through defining the rules of engagement. We look forward to working collaboratively and systematically with federal, state and private sector partners to see that electronic health information is available when and where it matters,” said Karen DeSalvo, M.D., national coordinator for health IT. Today’s announcement is linked with the administration’s Precision Medicine Initiative to improve care and speed the development of new treatments, as well as the Department-wide effort to achieve better care, smarter spending and healthier people through improvements to our health care delivery system. As part of this work, HHS is focused on three key areas: (1) improving the way providers are paid, (2) improving and innovating in care delivery, and (3)
sharing information more broadly to providers, consumers, and others to support better decisions while maintaining privacy. The draft Roadmap identifies critical actions to achieve success in sharing information and interoperability and outlines a timeframe for implementation. The draft Roadmap calls for ONC to identify the best available technical standards for core interoperability functions. With today’s announcement, ONC is delivering on this action with the release of the Draft 2015 Interoperability Advisory: The best available standards and implementation specifications for interoperability of clinical health information (“Standards Advisory”). The Standards Advisory represents ONC’s assessment of the best available standards and implementation specifications for clinical health information interoperability as of December 2014. “ONC’s interoperability Roadmap will help guide our progress toward seamless integration of electronic health record data,” said Mr. Christopher Miller, program executive officer for Defense Healthcare Management Systems within the Department of Defense. “We are proud to be working closely with ONC and other public and private partners to ensure that our health care providers have a complete picture of health information from all sources. The availability of this information increases the medical readiness of our operational forces and enables delivery of the highest quality care that our service members, veterans and their families deserve. We look forward to our continued partnership with ONC as we expand the safe and secure exchange of standardized healthcare data to improve the overall health of our nation.” “The benefits to patients and to the future of American health care in achieving full interoperability are enormous. A system built on accessible information and secure, meaningful data sharing will elevate health care delivery, advance quality and cost-efficiency and enable new strides in medical research. We applaud HHS and the Office of the National Coordinator for making interoperability a national priority and we believe that, by bringing together the ideas and technological expertise from both the public and private sectors, it is a foreseeable and achievable goal,” said Mary R. Grealy, president, Healthcare Leadership Council. “Interoperability plays a critical role in improving the quality, cost, and patient experience of care and is foundational to both consumer decision-making and new models of health care delivery and payment,” said Janet Marchibroda, director of the Health Innovation Initiative and executive director of the CEO Council on Health and Innovation at the Bipartisan Policy Center. “We applaud ONC’s leadership in creating the roadmap and releasing the standards advisory, as well as its ongoing commitment to public engagement in shaping a path forward.” “While we have made great strides as a nation to improve EHR adoption, we must pivot towards true interoperability based on clear, defined and enforceable standards,” said CHIME President and CEO Russell P. Branzell, F.C.H.I.M.E., C.H.C.I.O. “This Roadmap incorporates a tremendous amount of stakeholder input and articulates a clear path towards interoperability. It is a cornerstone in the continuing evolution of federal health IT policymaking.”
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Cerner Completes Acquisition of Siemens Health Services February 2, 2015 KANSAS CITY, MO -- Cerner Corp. today announced the completion of its acquisition of Siemens Health Services’ assets, client relationships and associates. Cerner and the former Siemens business unit have a combined annual research and development investment of more than $650 million. The cumulative resources are expected to speed delivery of the company’s next generation of health IT solutions, enabling clients to control costs and improve health care outcomes in their communities. “By combining client bases, investments in R&D and associates, we are in a great position to lead clients through one of the most dynamic eras in health care,” said Neal Patterson, Cerner chairman, CEO and co-founder. “Cerner remains focused on key development areas including population health, physician experience, open platforms, revenue cycle and mobility. We see these as critical areas of investment to ensure providers can meet growing regulatory demands and control costs, while continuing to improve quality of care.” Cerner and Siemens AG, the former parent company of Siemens Health Services, are also moving forward with a strategic alliance designed to advance industry innovation. The alliance pairs Cerner’s health IT leadership with Siemens AG’s device and imaging expertise. Each organization expects to invest up to $50 million during an initial three-year term. The early focus of the alliance is on integrating diagnostics and therapeutics into the electronic health record. “Siemens AG is a tenured company with a long and respected track record in health care,” said Patterson. “A unique feature of this acquisition is we’ll continue working with Siemens AG in a R&D capacity, in order to advance the interoperability of electronic health records with medical devices.” Cerner expects revenue in 2015 to be approximately $4.8 billion to $5 billion, with a client base spanning more than 30 countries across more than 18,000 facilities. “The Cerner client family has grown and so has our team. We’re now more than 21,000 associates strong across a global network, all with the singular focus of advancing the state of the art in health and care,” said Patterson.
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Kallo Selects IBM Cloud Technology to Help Transform Health Care in Remote Communities February 5, 2015 ARMONK, NY and MARKHAM, ONTARIO -- IBM and Kallo Inc. today announced that Kallo has deployed its remote health-care delivery system on the IBM cloud to bring advanced real-time medical services to rural areas of the world. Kallo’s mobile health-care systems will be used to build and extend primary care infrastructure in countries including Guinea and Ghana, making health care accessible to everyone. The company’s mission is to deliver public health services, manage communicable and infectious diseases such as Ebola, balance health care delivery inequities, and address rural disease and health threats. On-demand tele-health services will be delivered from the company’s global command center in Markham, Ontario and regional command centers in countries of operation. IBM provides Kallo with technology consulting and services as well as a cloud infrastructure hosted at the recently opened SoftLayer cloud center in Toronto. The Toronto location is part of IBM’s expanding global network of more than 40 centers serving a growing roster of clients looking to move to hybrid cloud computing environments that encompass open integration, data control and unique industry expertise. “The health-care industry is in a time of accelerating change that needs continual innovation,” said John Cecil, Kallo’s chairman and CEO. “IBM’s cloud technology enables us to ‘reach the unreached’ to scale and securely deliver North American standards of health care to some of the world’s most remote or underserved populations.” Kallo services include MobileCareTM, RuralCareTM, DialysisCareTM, hospital information systems, tele-health systems, pharmacy information, disaster management, air and surface patient transportation systems, and clinical training. The units work in collaboration with each other, with the mobile and rural clinics providing primary care. Secondary/local specialized care is provided by the regional command centers while the global command center provides specialized consultative care. With the volume of cases per country and the privacy and confidentiality standards in cross border tele-health practice, plans include dedicated global command centers for each country.
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St. Jude Medical Launches U.S. Study of the Country’s Smallest Pediatric Mechanical Heart Valve February 10, 2015 ST. PAUL, MN -- St. Jude Medical, Inc., a global medical device company, today announced the launch of the HALO U.S. IDE Trial. The trial will evaluate the safety and efficacy of the St. Jude Medical Masters HPTM Series 15mm mechanical heart valve, the smallest pediatric mechanical heart valve in the world. The HALO Trial will enroll pediatric patients in need of mitral valve replacement who cannot be implanted with the current range of approved valves without additional risks and who have no alternative approved treatment options. In the U.S. alone, more than 35,000 babies are born each year with congenital heart defects, some of which will impact valve function to the point they’ll require surgical valve replacement. For many of these patients, mechanical heart valves can effectively mimic natural heart valves, opening and closing with each heart beat and permitting blood flow into the heart. While there are several replacement valves of varying size available for older patients, there are no prosthetic heart valves under 16mm in tissue diameter approved for standard use in newborns, infants and toddlers. With limited availability of valves that can suitably match the anatomy of children under the age of five, some surgeons are forced to implant larger valves in their smallest patients, which may lead to suboptimal placement that can disrupt hemodynamics, damage to surrounding tissue and an elevated risk of side effects such as poor blood pressure and potential heart blockage. “There’s a profound need within the medical community for a mechanical heart valve dedicated to our tiniest patients who can’t safely be implanted with the current range of valve sizes,” said Dr. Kirk R. Kanter, professor of surgery at the Emory University School of Medicine and cardiothoracic surgeon and surgical director of the Heart Transplant Program at Children's Healthcare of Atlanta. “This small valve represents a big step forward in helping cardiovascular surgeons provide our patients the optimal level of care.” In 2007, the U.S. Congress passed the Pediatric Medical Device Safety and Improvement Act to prompt development of medical devices designed and engineered specifically for the pediatric patient population. With its legacy of innovation in the field of pediatric cardiology, St. Jude Medical was uniquely positioned to meet the challenge of designing a mechanical heart valve
that could provide very young patients a chance of survival until they can be implanted with a larger, permanent valve implant they will carry with them the rest of their life. The launch of the HALO IDE stems from a new approach to the design, evaluation and regulatory approval of pediatric heart valves that emerged from an FDA led workshop in 2010 organized in response to the pressing need to develop products for this patient population. In a speech held in October 2014 the St. Jude Medical pediatric heart valve was cited by FDA Commissioner Margaret A. Hamburg, M.D., as an example of what collaboration can achieve when industry, FDA staff, clinicians and academics come together to support pediatric medical device development. The HALO Trial will enroll patients at up to 40 sites nationwide. Data collected during the HALO Trial across all trial sites will be used to support FDA approval of the Masters Series 15mm mechanical heart valve, which is currently available only under “emergency or compassionate use” protocols. “The Masters Series 15mm mechanical heart valve was developed based on feedback we received from physicians and the FDA’s Office of Pediatric Therapeutics, who have expressed the need for a more suitable mechanical heart valve to offer pediatric patients for which there are simply no other options,” said Dr. Mark Carlson, vice president of global clinical affairs and chief medical officer at St. Jude Medical. “As a market leader in pediatric cardiology solutions, St. Jude Medicalhas the capability to develop devices that fill critical needs, and we will continue to look for more opportunities to create solutions for some of the biggest challenges facing pediatric surgeons and cardiologists today.” St. Jude Medical is a market leader in designing and developing electrophysiology and interventional cardiology solutions for pediatric patients worldwide. The company currently offers low voltage and high voltage pacemakers, ablation catheters and occluders to treat congenital heart defects for the pediatric population. In addition, St. Jude Medical is the most experienced mechanical valve company in the world, with more than 2 million valves implanted to date.
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New Affordable Care Act Initiative to Encourage Better Oncology Care February 12, 2015 BALTIMORE, MD -- The U.S. Department of Health and Human Services (HHS) today announced a new multi-payer payment and care delivery model to support better care coordination for cancer care as part of the Department’s ongoing efforts to improve the quality of care patients receive and spend health care dollars more wisely, contributing to healthier communities. The initiative will include 24-hour access to practitioners for beneficiaries undergoing treatment and an emphasis on coordinated, person-centered care, aimed at rewarding value of care, rather than volume. Cancer is one of the most common and devastating diseases in the United States: more than 1.6 million people are diagnosed with cancer each year in this country. According to the National Institutes of Health, cancer cost the United States an estimated $263.8 billion in medical costs and lost productivity in 2010. A majority of those diagnosed are over 65 years old and Medicare beneficiaries. “Based on feedback from the medical, consumer and business communities, we are launching this new model of care to support clinicians’ work with their patients,” said Patrick Conway, M.D., CMS chief medical officer and deputy administrator for innovation and quality. “We aim to provide Medicare beneficiaries struggling with cancer with high-quality care around the clock and to reward doctors for the value, not volume, of care they provide. Improving the way we pay providers and deliver care to patients will result in healthier people.” As part of the Department’s “better care, smarter spending, healthier people” approach to improving health delivery, the Oncology Care Model is one of many innovative payment and care delivery models developed by the Centers for Medicare & Medicaid Services (CMS) Innovation Center and advanced by the Affordable Care Act. The model was created in response to feedback from the oncology community, patient advocates, and the private sector that a new way of paying for and delivering oncology care is needed. This model will invest in physician-led practices, allowing the practices to innovate and deliver higher-quality care to their patients. CMS is seeking the participation of other payers in the model to leverage the opportunity to transform care for oncology patients across a broader population.
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Cerner, Mortara Introduce CareAware Waveform Management February 12, 2015 KANSAS CITY, MO -- Cerner Corp., one of the largest health information technology suppliers, and development partner Mortara Instrument, a leading U.S. manufacturer of diagnostic cardiology instrumentation, including multi-parameter patient monitoring, have joined together to introduce CareAware Waveform Management™. The new solution displays waveforms and other physiological data from patient monitoring systems and integrates them into the Electronic Health Record (EHR). “This solution is one of the final steps toward creating a fully digital hospital,” said Stephanie Rogers, RN-BC and director of critical care at Cerner. “Although hospitals are working toward a fully integrated digital care process, today they are still subjected to printing rolls of paper strips to monitor patient waveforms. We expect the integration of physiological waveforms and data into the electronic health record will lead to enhanced decision-making and improved patient outcomes by streamlining documentation and viewing of waveforms in the context of other relevant patient information.” With CareAware Waveform Management, clinicians will be able to view physiologic waveforms, data and alarms on devices with access to the patient record. Caregivers will be able to monitor patient waveforms in the context of other relevant patient information. The solution will help streamline documentation by enabling clinicians to electronically view, measure, annotate and save waveform strips to the EHR, eliminating one of the final pieces of paper in the hospital setting. “Bringing Mortara’s waveform management capabilities to the Cerner solution reflects our vision of fully integrating medical devices into ever more connected EHR systems,” said Dr. Justin Mortara, CEO of Mortara. “We are confident that, by extending waveform capabilities to CareAware, clinicians will realize easier access to relevant data.” The University of Missouri (MU) Health Care and Cerner leveraged their collaborative relationship with the Tiger Institute to alpha test the new waveform technology with live data. “MU Health Care is committed to providing high-quality patient care throughout our clinical enterprises,” said Bridgett Robbins, RN, clinical manager, MU Health Care. “As the alpha client of Cerner’s CareAware Waveform Management solution, this partnership helps us move toward our goal of implementing innovative and progressive processes to provide superior care.”
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NIH-Funded Scientists Create Potential LongActing HIV Therapeutic February 19, 2015 Scientists have created a new molecule that shows promise for controlling HIV without daily antiretroviral drugs. The molecule foils a wider range of HIV strains in the laboratory than any known broadly neutralizing HIV antibody and is more powerful than some of the most potent of these antibodies. In addition, the molecule safely protected monkeys from infection with an HIV-like virus during a 40-week study period. Together, the data suggest that the molecule could, with further research, be used to subdue HIV in humans. The authors note that the molecule potentially could be used as both a preventative drug and as a treatment. The new findings appear in the February 18 issue of the journal Nature. “This innovative research holds promise for moving us toward two important goals: achieving long-term protection from HIV infection, and putting HIV into sustained remission in chronically infected people,” said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The research was led by Michael Farzan, Ph.D., a professor in the department of infectious diseases at The Scripps Research Institute in Jupiter, Florida. The work was funded primarily by NIAID. The new molecule is called eCD4-Ig and works by tightly binding to two unchanging sites on the surface of HIV that the virus uses to attach to receptors on cells called CD4 and CCR5. Typically, when HIV attaches to these receptors, it unlocks a door to the cell and gets inside. However, when eCD4-Ig binds to HIV, it effectively takes away the virus’s key, locking it out of the cell and preventing it from multiplying. To make eCD4-Ig, the scientists took an antibodylike molecule that latches onto the CD4 binding site but does not neutralize HIV on its own, and fused it with a short protein fragment that attaches tightly to the CCR5 binding site. Together, these two arms of the molecule are much more effective at stopping HIV than either one is alone. To test whether eCD4-Ig would protect monkeys from an HIV-like virus (simian immunodeficiency virus, or SIV), the scientists synthesized genetic instructions for making the molecule and placed them inside a harmless carrier virus called adeno-associated virus, or AAV. This gene-therapy tool was designed such that once the AAV-modified virus infected a cell, it would cause the cell to make eCD4-Ig indefinitely. The researchers injected the genetically modified AAV into four monkeys. Then they exposed both the treated monkeys and four untreated monkeys to SIV six times at increasingly higher doses over a 34-week period. None of the treated monkeys became infected with SIV, while all of the untreated monkeys did.
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Booz Allen Hamilton Partners with HITRUST on Series of Cyber Preparedness and Education Town Halls for Healthcare Industry February 19, 2015 MCLEAN, VA -- Booz Allen Hamilton has partnered with the Health Information Trust (HITRUST) Alliance to hold a CyberRX 2.0 cyber preparedness, education and simulation event in Washington, D.C., on March 25, 2015. The Cyber Town Hall event will feature participants from the healthcare industry as well as from the U.S. Department of Health and Human Services (HHS), Federal Bureau of Investigation (FBI) and the U.S. Department of Homeland Security (DHS). This “Cyber Town Hall” session, which is part of the ongoing HITRUST CyberRX 2.0 program, is the first in a series of events Booz Allen will host in major cities across the U.S. The Cyber Town Hall session in D.C. will provide an opportunity for attendees from the government, insurers, hospitals and other providers to learn how to assess their ability to respond effectively to cyber threats and attacks, and understand what resources from HHS, FBI, DHS and HITRUST are available to improve collaboration and cyber intelligence sharing. “Given recent high-profile cyber attacks perpetrated against the health care industry and the overall increase in incidents HITRUST is seeing in its cyber center both in volume and sophistication, the CyberRX Cyber Town Hall events are more urgent and critical than ever. We are pleased to partner with Booz Allen Hamilton and its recognized experts in cybersecurity programs, to offer the D.C. and other events around the country,” said Daniel Nutkis, CEO, HITRUST. “HITRUST is committed to continuing to provide critical support and protect the U.S. healthcare industry from disruption by cyber attacks through important programs including HITRUST CyberRX, the HITRUST Cyber Threat Intelligence and Incident Coordination Center (C3), HITRUST Cyber Threat Briefings and the HITRUST Cyber Threat XChange. Thousands of healthcare organizations have already benefitted from these services and we expect to see a critical mass of interest and participation this year that will transform the way the industry approaches information security.” The Cyber Town Hall session allows organizations to learn about the CyberRX 2.0 program and assess their response and threat preparedness against healthcare cybersecurity attacks.
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Surescripts Leverages Technology to Help Doctors Address Prescription Fraud and Abuse February 19, 2015 ARLINGTON, VA -- Surescripts, the nation’s largest health information network, is working industry-wide to improve care and curb prescription fraud, diversion and abuse by connecting pharmacists and doctors and encouraging the adoption of electronic prescribing of controlled substances (EPCS). In 2015, Surescripts expects to deliver at least 5 million electronic prescriptions of controlled substances, representing an increase of nearly 400 percent over the prior year. “A number of complex regulatory and technology requirements exist, and the amount of misinformation about EPCS is daunting, with many prescribers unaware that they have this option or that it’s legal,” said David Yakimischak, Executive Vice President and General Manager at Surescripts. “By eliminating the paper prescription and connecting physicians and pharmacists electronically, there is an opportunity to improve care, reduce fraud, and identify potential instances of abuse.” Currently, electronic prescribing of controlled substances is legal in 48 states plus the District of Columbia, and lawmaking is pending in Montana and Missouri to allow the practice by the middle of this year. New York is taking it a step further and requiring that prescriptions for all drugs, including controlled substances, be delivered electronically. “It’s important that we take steps as an industry to enable the flow of information about prescribing patterns for controlled substances to help manage fraud and abuse,” said Bob Robke, Vice President for Interoperability Strategies and Solutions at Cerner. “Creating an interoperable network for providers and pharmacies to share this information gets us one step closer to breaking down interoperability barriers across all of health care.” Across the country, more than 70 percent of pharmacies are ready to receive electronic prescriptions for controlled substances, but the number of prescribers who are ready to send them is approximately six percent. This is despite the fact that more than 60 percent of prescribers who already e-prescribe use software that has at least one EPCS-certified version enabled today. Beyond the required software updates, medical practices must complete several additional steps before they can legally send electronic prescriptions for controlled substances. To make this process easier for doctors and to help them get started, Surescripts has created a step-by-step video guide and tools available at www.getEPCS.com.
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HHS Invests in Enhancing Domestic Preparedness Efforts for Ebola February 20, 2015 WASHINGTON, DC -- The Department of Health and Human Services released a new funding opportunity announcement (FOA) today: the Hospital Preparedness Program (HPP) Ebola Preparedness and Response Activities. This funding opportunity will award a total of $194,500,000 to states and other grantees for Ebola health care system preparedness and response and the development of a regional Ebola treatment strategy. This funding, in addition to the Ebola emergency funds that will soon be awarded through the Public Health Emergency Preparedness (PHEP) program, provides a total investment of $339,500,000 to enhance state, local and health care system preparedness for Ebola through the emergency appropriations passed with bipartisan support in Congress in December 2014. These funds build on gains that have been made in health care and public health preparedness efforts over the past decade through the HPP and PHEP cooperative agreements with states. “I’d like to thank cities, states, and hospitals across the country and the public health community for stepping up and taking action,” said HHS Assistant Secretary for Preparedness and Response (ASPR) Dr. Nicole Lurie. “We are building on the work we’ve already done and further investing in domestic preparedness to protect the public’s health from Ebola, as well as boosting preparedness for many other types of health threats.” Since last fall, the United States has strengthened domestic preparedness and response efforts. State and local public health officials, with technical assistance from the Centers for Disease Control and Prevention (CDC) and ASPR, collaborated with hospital officials across the U.S. to increase domestic capacity to care for patients with Ebola. Important lessons were also learned during the response effort. Safety of health care workers must be foremost in health care system preparedness and response activities; the care of Ebola patients is clinically complex and demanding; and early case recognition is critical for preventing spread and improving outcomes. Assuring that Ebola patients are safely and well cared for in the U.S. health care system and that frontline providers are trained to recognize and isolate a person with suspected Ebola are the cornerstones of the Hospital Preparedness Program Ebola funding announcement.
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3D Systems Debuts Powerful New All-In-One Medical 3D Printer at LMT LAB DAY Chicago February 24, 2015 ROCK HILLS, SC -- 3D Systems announced today the immediate availability of its revolutionary all-in-one medical 3D printer, the ProJet 3510 DPPro, which the company plans to debut at LMT LAB DAY Chicago 2015. The ProJet 3510 DPPro, the latest in 3DS' stellar MultiJet (MJP) line, gives medical and dental labs the power to print precision dental waxups; durable implant drill guides; temperature-resistant, thermoformable orthodontic patterns; and crown and bridge molds interchangeably, at up to twice the throughput of today's printers. Armed with the ProJet 3510 DPPro's game-changing speed, throughput and versatility, dental and medical labs can print precision, personalized medical tools and devices created directly from patients' data, in a matter of hours—all in a smaller footprint than existing medical printers. “Our primary purpose is to democratize access to more affordable and powerful tools for the benefit of our customers. With its high resolution, high capacity and expanded material compatibility, the DPPro can support the widest range of medical applications, at a very low cost of ownership,” said Buddy Byrum, Vice President, Product Management, 3DS. “LMT LAB DAY is the perfect venue to demonstrate this new, multipurpose machine to those who will benefit most from it.” Engineered specifically for demanding dental and medical lab environments, the multipurpose ProJet 3510 DPPro 3D printer provides round-the-clock printing capabilities and features a large build volume, allowing lab managers to rethink maximum throughput and tighten production schedules. With the ProJet 3510 DPPro's variety of specifically engineered materials, labs can print enhanced, highly accurate wax-ups for crowns, bridges and partial denture frameworks, in addition to working models for crown and bridge, orthodontic, partial dentures, and medical models, such as a jaw models, in USP Class VI-capable VisiJet® Stoneplast. The ProJet DPPro also produces superior, customized implant drill guides in a durable biocompatible plastic material. Enhanced with efficient material use, low-maintenance operation and an unprecedented five-year print head warranty, the ProJet DPPro conveniently melds with existing workflows and pays owners back on their investment faster.
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New Data from CCN Demonstrate Potential of CT to Transform the Cardiac Care Pathway March 4, 2015 VIENNA -- Centre Cardiologique du Nord, Saint Denis today presented data at the European Congress of Radiology (ECR) that show GE Healthcare’s new Revolution* CT scanner could impact the way in which coronary artery disease is diagnosed and managed. The findings of the study, which was carried out under the leadership of Drs. Jean-Louis Sablayrolles, Laurent Macron and Jacques Feignoux, showed GE Healthcare’s Revolution CT produced high quality images using lower doses of radiation for cardiac exams even with clinically-challenging patients, contributing to more confident diagnoses at lower patient doses. According to the authors, the findings suggest the possibility that high performance CTs such as Revolution CT could be used as a first-line examination in the evaluation of coronary artery disease. Coronary Computed Tomography Angiography (CCTA) is a well-established non-invasive imaging technique used in the detection of coronary artery disease (CAD). It offers an alternative to exercise stress tests or coronary angiography (IC) for diagnosis, the latter being an invasive procedure that uses a catheter threaded through the blood vessels to the heart. However, a number of factors limit the use of CCTA in cardiac care. Patients with high heart rates or arrhythmia can be challenging to diagnose with confidence because high heart rates can introduce motion artefacts, making it difficult to find an appropriate phase of the cardiac cycle suitable for the analysis of all coronary segments. Levels of radiation exposure for patients are also a concern. GE Healthcare’s Revolution CT has been developed to help address these challenges, allowing the heart to be imaged in one beat, whatever the heart rate, while helping to reduce dose by up to 82% when the new reconstruction algorithm ASiR-V* is applied1. The study at CCN scanned 58 patients with high heart rates (>65 bpm) to compare the image quality and radiation dose of the Revolution CT 512-slice scanner with the previous generation 128-slice technology (Discovery CT750 HD). 58 patients with high heart rates were scanned in two groups of 29. The study found that Revolution CT images ranked higher on a five-point Likert scale. The Revolution CT also successfully imaged a very high percentage of assessable coronary segments, even though this group of challenging patients had a mean heart rate 75.7 ± 9.9 bpm. Dr. Sablayrolles, head of CT Cardiac Imaging Radiology at Centre Cardiologique de Nord (CCN) in Saint-Denis, France was the first user of Revolution CT in Europe.
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Northeastern University Researchers Find Inhaling Supplemental Oxygen Can Awaken Anti-Tumor Cells March 4, 2015 BOSTON, MA -- Northeastern University researchers have found that inhaling supplemental oxygen—40 to 60 percent oxygen as opposed to the 21 percent oxygen in air—can weaken immunosuppression and awaken anti-tumor cells. The new approach, some 30 years in the making, could dramatically increase the survival rate of patients with cancer, which kills some 8 million people each year. The breakthrough findings were published Wednesday in Science Translational Medicine. Michail Sitkovsky, an immunophysiology researcher at Northeastern,and his team found that supplemental oxygenation inhibits the hypoxia-driven accumulation of adenosine in the tumor microenvironment and weakens immunosuppression. This, in turn, could improve cancer immunotherapy and shrink tumors by unleashing anti-tumor T lymphocytes and natural killer cells. Breathing supplemental oxygen opens up the gates of the tumor fortress and wakes up ‘sleepy’ anti-tumor cells, enabling these soldiers to enter the fortress and destroy it,” explained Sitkovsky, the Eleanor W. Black Chair and Professor of Immunophysiology and Pharmaceutical Biotechnology at Northeastern and the founding director of the university’s New England Inflammation and Tissue Protection Institute. “However, if anti-tumor immune cells are not present, oxygen will have no impact.” The findings build upon Sitkovsky’s previous research and represent the culmination of his life’s work, which has been supported by Northeastern and the National Institutes of Health. In the early 2000s, Sitkovsky made an important discovery in immunology, which has come to inform his research in cancer biology. He found that a receptor on the surface of immune cells—the A2A adenosine receptor—is responsible for preventing T cells from invading tumors and for “putting to sleep” those killer cells that do manage to enter into the tumors. His latest work shows that supplemental oxygen weakened tumor-protecting signaling through the A2A adenosine receptor and wakes up the T cells that were able to invade lung tumors. “This discovery shifts the paradigm of decades-long drug development, a process with a low success rate,” Sitkovsy said.
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Saving Precious Time: Siemens’ New Ultrasound System for Faster Imaging March 4, 2015 ERLANGEN, GERMANY -- At this year's European Congress of Radiology (ECR) in Vienna, Austria, Siemens Healthcare introduces its new hand-carried Acuson P500 ultrasound system, Frosk edition. It allows reliable and fast imaging by offering new and timetested high-end imaging technology in a compact and easy-to-use device, making it particular suitable for the use in the emergency medicine and general imaging. When every second counts, clear image quality means precious time saved. Hence Siemens' newest member in the Acuson P Family of portable ultrasound systems, the Acuson P500, Frosk edition introduces two new premium technologies that continuously provide sharp ultrasound images, regardless of patient and probe motion: Dynamic Persistence and patent-pending Auto Flash Artifact Suppression. Both technologies were specially designed for the new system and work together to detect movements that affect image quality, and automatically reduce noise while simultaneously enhancing color sensitivity for clear images. Additionally, the new ultrasound system features established high-performance imaging tools migrated from Siemens' Acuson S Family of premium ultrasound systems such as Advanced SieClear spatial compounding and Dynamic TCE tissue contrast enhancement technology for excellent 2D color Doppler image quality. All this comes in a compact notebook format of 15-inches (38 cm), weighing under 8 kilograms. Equipped with a battery that offers up to 60 minutes of scanning time, the new platform can be easily carried and positioned in any clinical environment, helping clinicians make quick decisions even in difficult scanning conditions. With a standard rapid boot-up feature, the system is ready for scanning in less than 30 seconds. The Acuson P500 system's clear user interface is easy to learn and operate for users of all experience levels. It features a highly sensitive touch screen display with advanced infrared (IR) technology for accurate gesturing. A dual interface control panel offers flexible use of the touch screen or a traditional control panel based on each user's own scanning preferences, allowing them to spend less time on the system and more time on the patient. “The compact Acuson P500 system, Frosk edition is ideal for any setting where performance is critical and space is limited for instance in emergency settings,” says Jeffrey Bundy, CEO of the Siemens Healthcare Ultrasound Business Unit. “The combination of our two new motion controlling technologies designed specifically for this platform offer unprecedented image quality and ease of use, meeting the needs of general imaging and point-of-care ultrasound.”
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GE Ventures and Stanford Health Care Launch Digital Health Company March 5, 2015 MENLO PARK, CA -- Today, GE Ventures and Stanford Health Care announced the launch of Evidation Health, an independent company committed to improving health outcomes with evidence-based digital medicine. Focused on generating real-world clinical and economic evidence for digital health products and platforms, Evidation Health combines health outcomes data with new approaches to predictive analytics to identify and deploy the most effective and efficient patient management strategies and interventions. Evidation Health Chief Executive Officer Deborah Kilpatrick, said, “Our company has the core capabilities to make precision digital medicine a reality. We envision a digital health-enabled future where clinical interventions can be customized and concentrated in ways that maximize clinical and economic benefit for payers, providers and, most importantly, patients.” According to digital health seed fund Rock Health, more than $4B was invested in over 250 digital health companies in 2014 alone. As this new breed of disruptive tools and technologies enter the market, healthcare purchasers struggle to identify those that will most significantly impact outcomes and improve patient care. Rowan Chapman, managing director of new business creation at GE Ventures said, “Digital disruption in the health care industry has introduced a number of new but often unproven products and services. With Evidation Health, we will be able to not only improve outcomes, but also ensure that the best products reach patients.” To accelerate commercial progress, Evidation Health joined forces with The Activity Exchange, a digital health company with strong predictive analytics capabilities, and closed its Series A financing in January of 2015. The round was led by GE Ventures, with participation from Asset Management Ventures and Rock Health. The company is focused on forging new partnerships while continuing its corporate and academic collaborations with Humana, Biogen Idec., Sanofi, Harvard Business School and Wharton, amongst others. Stanford Health Care President and CEO Amir Dan Rubin, said “Stanford Health Care is committed to delivering integrated solutions to the complex problems patients face, and those solutions will increasingly be advanced through digital health.”
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FDA Approves First Biosimilar Product Zarxio March 6, 2015 The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:
patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia.
“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg, M.D. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.” The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act that President Obama signed into law in March 2010. The BPCI Act created an abbreviated licensure pathway for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product, called the “reference product.” This abbreviated licensure pathway under section 351(k) of the Public Health Service Act permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, and enables a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data.
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Concordia Healthcare Corp. to Acquire Covis Pharma Commercial Assets for $1.2 Billion March 9, 2015 TORONTO -- Concordia Healthcare Corp. (“Concordia” or the “Company”), a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population, today announced it has entered into a definitive asset purchase agreement to acquire substantially all of the commercial assets of privately held Covis Pharma S.à.r.l and Covis Injectables, S.à.r.l (together “Covis”) for US$1.2 billion in cash. All financial references are in U.S. dollars unless otherwise noted. The Covis drug portfolio being acquired (the “Portfolio”) consists of 18 branded and authorized generic products with stable revenue, strong margins and free cash flow. The distinctive product portfolio includes branded pharmaceuticals, injectables and authorized generics that address life threatening and other serious medical conditions in various therapeutic areas including cardiovascular, central nervous system, oncology and acute care markets. Key products are Nilandron®, for the treatment of metastatic prostate cancer; Dibenzyline®, for the treatment of pheochromocytoma; Lanoxin®, for the treatment of mild-to-moderate heart failure and atrial fibrillation; and, Plaquenil®, for the treatment of lupus and rheumatoid arthritis. In its fourth quarter of 2014, Covis expects to have revenue between US$47 and US$52 million related to the Portfolio. Overall for 2014, Covis expects to have revenue between US$140 and US$145 million with a gross profit margin of approximately 90%. Concordia believes that it can integrate the Portfolio it is acquiring into its existing business and leverage its existing infrastructure. Through the elimination of redundant distribution and G&A expenses, Concordia expects to recognize immediate synergies of approximately $20 million. “Covis’ strong commercial momentum will have an immediate and material impact on our top and bottom line financial results,” said Mark Thompson, Chief Executive Officer of Concordia. “In the longer-term, this transaction creates greater scale and diversification for Concordia, which should support the continued execution of our aggressive growth plans.”
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Apple Introduces ResearchKit, Giving Medical Researchers the Tools to Revolutionize Medical Studies March 9, 2015 SAN FRANCISCO -- Apple® today announced ResearchKit™, an open source software framework designed for medical and health research, helping doctors and scientists gather data more frequently and more accurately from participants using iPhone® apps. Worldclass research institutions have already developed apps with ResearchKit for studies on asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease. Users decide if they want to participate in a study and how their data is shared. “iOS apps already help millions of customers track and improve their health. With hundreds of millions of iPhones in use around the world, we saw an opportunity for Apple to have an even greater impact by empowering people to participate in and contribute to medical research,” said Jeff Williams, Apple’s senior vice president of Operations. “ResearchKit gives the scientific community access to a diverse, global population and more ways to collect data than ever before.” ResearchKit turns iPhone into a powerful tool for medical research. When granted permission by the user, apps can access data from the Health app such as weight, blood pressure, glucose levels and asthma inhaler use, which are measured by third-party devices and apps. HealthKit™ is a software framework Apple introduced with iOS 8 to provide developers the ability for health and fitness apps to communicate with each other. ResearchKit can also request from a user, access to the accelerometer, microphone, gyroscope and GPS sensors in iPhone to gain insight into a patient’s gait, motor impairment, fitness, speech and memory. ResearchKit also makes it easier to recruit participants for large-scale studies, accessing a broad cross-section of the population—not just those within driving distance of an institution. Study participants can complete tasks or submit surveys right from the app, so researchers spend less time on paperwork and more time analyzing data. ResearchKit also enables researchers to present an interactive informed consent process. Users choose which studies to participate in and the data they want to provide in each study. “We’re excited to use these new ResearchKit tools from Apple to expand participant recruitment and quickly gather even more data through the simple use of an iPhone app. The data it will provide takes us one step closer to developing more personalized care,” said Patricia Ganz, MD,
professor at the UCLA Fielding School of Public Health and Director of Cancer Prevention & Control Research at UCLA’s Jonsson Comprehensive Cancer Center. “Access to more diverse patient-reported health data will help us learn more about long-term aftereffects of cancer treatments and provide us with a better understanding of the breast cancer patient experience.” “When it comes to researching how we can better diagnose and prevent disease, numbers are everything. By using Apple’s new ResearchKit framework, we’re able to extend participation beyond our local community and capture significantly more data to help us understand how asthma works,” said Eric Schadt, PhD, the Jean C. and James W. Crystal Professor of Genomics at the Icahn School of Medicine at Mount Sinai, and Founding Director of the Icahn Institute for Genomics and Multiscale Biology. “Using iPhone’s advanced sensors, we’re able to better model an asthma patient’s condition to enable us to deliver a more personalized, more precise treatment.” Developed by the Icahn School of Medicine at Mount Sinai and LifeMap Solutions, the Asthma Health app is designed to facilitate asthma patient education and self-monitoring, promote positive behavioral changes and reinforce adherence to treatment plans according to current asthma guidelines. The study tracks symptom patterns in an individual and potential triggers for these exacerbations so that researchers can learn new ways to personalize asthma treatment. The Share the Journey app, developed by the Dana-Farber Cancer Institute, Penn Medicine, Sage Bionetworks and UCLA’s Jonsson Comprehensive Cancer Center, is a research study that aims to understand why some breast cancer survivors recover faster than others, why their symptoms vary over time and what can be done to improve symptoms. Share the Journey will use surveys and sensor data on iPhone to collect and track fatigue, mood and cognitive changes, sleep disturbances and reduction in exercise. Developed by Stanford Medicine, the MyHeart Counts app measures activity and uses risk factor and survey information to help researchers more accurately evaluate how a participant’s activity and lifestyle relate to cardiovascular health. By studying these relationships on a broad scale, researchers will be able to understand better how to keep hearts healthier. Massachusetts General Hospital developed the GlucoSuccess app to understand how various aspects of a person’s life—diet, physical activity and medications—affect blood glucose levels. The app can also help participants identify how their food choices and activity relate to their best glucose levels, enabling them to clearly see correlations and take more active roles in their own well-being. Developed by Sage Bionetworks and the University of Rochester, the Parkinson mPower app helps people living with Parkinson’s disease track their symptoms by recording activities using sensors in iPhone. These activities include a memory game, finger tapping, speaking and walking. Activity and survey data from your phone are combined with data from many other participants to fuel Parkinson’s research at a scale never before possible, making this the world’s largest and most comprehensive study of this disease.
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FDA Approves CPR Devices That May Increase Chance of Surviving Cardiac Arrest March 9, 2015 The U.S. Food and Drug Administration approved the ResQCPR System, a system of two devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on people whose hearts stop beating (cardiac arrest). The devices may improve the patient’s chances of surviving cardiac arrest. The Centers for Disease Control and Prevention estimates that approximately 300,000 Americans experience an out-of-hospital cardiac arrest each year. CPR is an emergency procedure that can be life-saving for people in cardiac arrest. During this procedure, rescuers manually compress the patient’s chest and manually ventilate the lungs to keep blood oxygenated and circulating until the heart and breathing restart—or until the rescuers can apply advanced life-saving techniques, such as defibrillation. If provided immediately after cardiac arrest, this standard CPR procedure increases a patient’s chance of survival. The ResQCPR System consists of two devices that are intended to be used together to assist in performing CPR on adult patients with out-of-hospital, non-traumatic cardiac arrest. The first device, the ResQPump Active Compression Decompression CPR Device, has a double-grip handle that attaches to the patient’s chest with a suction cup, allowing the rescuer to push to deliver compressions and lift for decompressions, which is different than standard CPR. It also includes a pressure gauge to help rescuers maintain recommended compression depth and a timing mechanism to help the rescuer maintain the necessary compression rate. The second device, the ResQPod 16.0 Impedance Threshold Device, fits onto a rescue face mask or breathing tube. When placed on the patient, it impedes airflow into the chest during chest decompression with the ResQPump, reducing the pressure inside the patient’s chest and drawing more blood back to the heart, a concept known as preloading. A greater volume of blood being drawn into the heart can mean a greater volume of blood flowing out of the heart during the next compression which may improve overall blood circulation as compared to standard CPR. When used together, the two devices may increase the amount of oxygenated blood circulated through a patient’s body during CPR. “Most people who suffer cardiac arrest outside of a hospital die,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The ResQCPR System may increase oxygenated blood circulation during CPR, which in turn may improve the likelihood of survival in adult patients with out-of-hospital, non-traumatic cardiac arrest.”
Event
Centers for Medicare and Medicaid Services (CMS) CISO Security & Privacy Forum April 7, 2015: Woodlawn, MD The CISO Security & Privacy Forum is hosted by the Information Security Privacy Group (ISPG) at CMS. The Vision for ISPG is to provide leadership to CMS in managing information security and privacy risks appropriate for evolving cyber threats. The Mission is to enable the safe use of sensitive and privacy data while servicing the healthcare needs of the nation. The format for this event will include briefings from government and industry. Our featured speaker is from the Interagency OPSEC Support Staff and will present on “TRASHINT: Dumpster Diving,” a very popular topic which teaches attendees how one person's trash can be another person's treasure. We are currently seeking presenters on Identity Theft and Cloud Security. Table top displays from prime contractors and small businesses will be a highlight for information exchange and networking. Each Marketing Service Package Includes: Pre-event promotional activity by FBC including postcards, posters and table tents placed throughout agency All-hands agency email to go out to CMS personnel from event host Customizable email template provided to invite current contacts Event Day: Admission for 2 company reps at the expo and training sessions Company description and contact info distributed to each attendee in the Exhibitor Guide Increased brand awareness through face-to-face interaction with agency attendees 6’ table, 2 chairs and standard electricity Continental breakfast and lunch will be provided Centers for Medicare and Medicaid Services Auditorium Woodlawn, MD For more information, visit: https://www.fbcinc.com
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HIMSS15 Annual Conference & Exhibition April 12-16, 2015: Chicago, IL The 2015 Annual HIMSS Conference & Exhibition, April 12-16 in Chicago, is the one must-attend event in the healthcare IT industry. HIMSS15 brings together 38,000+ healthcare IT professionals, clinicians, executives and vendors from around the world. Exceptional education, world-class speakers, cutting-edge health IT products and powerful networking are hallmarks of this industry-leading conference. More than 300 education programs feature keynotes, thought leader sessions, roundtable discussions and e-sessions, plus preconference symposia and workshops. No matter where you are in your career—a manager or director looking to optimize and maximize, a senior-level professional in need of new ideas, or just starting out—HIMSS15 has a track record of delivering the best cutting-edge education, pioneering health IT products services and solutions and opportunities to meet industry leaders and expand your network. This year’s conference is set to offer even more value. George W. Bush headlines a prominent panel of keynote speakers, including Alexander Gourlay and Bruce Broussard. Favorite exhibits such as the Connected Patient Gallery and the Federal Health IT Pavilion will make a reappearance, but various new education and networking sessions have been added to the program. These novel additions include miss must-see locations like Big Data, Mobile Health Knowledge Center and Cybersecurity Command Center in the exhibit halls. McCormick Place Convention Center 2301 S Martin Luther King Drive Chicago, IL 60616 For more information, visit: http://www.himssconference.org/
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2015 Preparedness Summit April 14-17, 2015: Atlanta, GA In an increasingly interconnected world, public health threats can emerge on the other side of the globe and arrive within a day on the doorstep of health departments, healthcare providers, schools, and more. Global health security preparedness issues such as protecting against infectious disease, the health effects of climate change and extreme weather, and cybersecurity threats to critical infrastructure, impact all levels of governmental public health and healthcare agencies. The Preparedness Summit is the premier national conference in the field of public health and healthcare preparedness and one of the only cross-disciplinary learning opportunities to address issues such as global health security. The Preparedness Summit is the first and longest running national conference on public health preparedness. Since its beginning in 2006, the National Association of County and City Health Officials (NACCHO) has taken a leadership role in convening a wide array of partners to participate in the Summit; presenting new research findings, sharing tools and resources, and providing a variety of opportunities for attendees to learn how to implement model practices that enhance the nationâ&#x20AC;&#x2122;s capabilities to prepare for, respond to, and recover from disasters and other emergencies. Last year, this 4-day annual event brought over 1,600 attendees to Atlanta, Georgia from nearly every state in the nation as well as several territories and countries, including China and Australia. In 2015, the Summit returns to the Atlanta Marriott Marquis from April 14-17 and we hope you will join us! The largest event of its kind, the 2015 Preparedness Summit will attract nearly 1,800 attendees who work all levels of government (local, state, and federal), emergency management, volunteer organizations, and healthcare coalitions. The 2015 Preparedness Summit also delivers opportunities to connect with colleagues and share new research. Most importantly, attendees will learn how to implement model practices that enhance capabilities to prepare for, respond to, and recover from disasters and emergencies. Atlanta Marriott Marquis 265 Peachtree Center Avenue NE Atlanta, GA 30303 For more information, visit: http://preparednesssummit.org/
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Military and Government Electronic Health Records & Health Data Interoperability Symposium April 28-29, 2015: Arlington, VA As part of the Omnibus Appropriations Bill, the Federal Government has set goals for the Department of Defense and the U.S. Department of Veterans Affairs around the former’s Electronic Health Record selection process and its work with the latter to achieve interagency interoperability with the VistA EHR. This unique symposium will provide attendees with critical and timely information on the latest advancements in government and military EHR interoperability, analytics, mobility, and patient privacy technologies that every health care professional must know. The event features over 25 leading health care experts from OUSD(AT&L)/DoD, DVA/VBA/VHA, VA/VLER, Gov/VA, DHHS, DoD/OT&E, ONC/DHHS, ARNG, USA/OTSG, Allscripts, Kaiser Permanente, PwC, KPMG, Walter Reed NMMC, Yale NewHaven HS, Stanford Medical Center, SAMHSA/CSAT, CSC, Oracle, HP, IHS, eHI, MAeHC, and OSEHRA presenting:
Emerging EHR & Health Data Interoperability IT Needs and Initiatives & Opportunities Department of Veterans Affairs & DoD Updates for AHLTA & VistA Information Assurance and Cyber Security Best Practices for Patient Privacy Exploiting Big Data HIT and Next-Generation EHRs & Mobile Technologies The Cloud and What You Must Know for a Secure, Virtual Lifetime EHR
Holiday Inn Rosslyn at Key Bridge 1900 North Fort Myer Drive Arlington, VA 22209 For more information, visit: http://www.militaryelectronichealthcare.com/
Event
VA Healthcare Summit 2015 May 11-13, 2015: Washington, DC The medical care requirements of our veterans have evolved due to the influx of military operations experienced by the United States throughout the past few decades. While once daunting, meeting these requirements are now feasible as a result of the many advancements across the Veterans Health Administration. However, facilitating this exceptional level of care is not without challenges. VA Healthcare 2015 will bring together strategic leaders and experts within the Veterans Affairs to share the best practices that have helped successfully implement new technology upgrades, clinical care advancements, and more precise administrative efficiencies. We Will Examine Topics Including: Future of mental healthcare within the VA Health informatics in the future of VA care Technology upgrades that will impact the patient experience such as Telehealth, Vista Evolution and Health Informatics for Mental Health Care Innovations in women’s specific care Treating the growing threat of traumatic brain injury Administrative innovations through enhancing Veterans Benefits Management System and Veterans Claims Intake Program New VA leadership structure and how it will transform the future of the VHA Implementing Lean Six Sigma to improve VA efficiency and productivity Benefits of Attending: Receive CME credits for 2015 Hear from 20+ expert speakers leading VA healthcare initiatives across the US Gain your Lean Six Certification during our Lean Six Sigma Focus Day Create your own agenda by choosing from our Technology, Clinical Care, and Administrative Tracks Kellogg Conference Hotel 800 Florida Avenue NE Washington, DC 20002 For more information, visit: http://www.veteransaffairshealthcare.com/
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2015 ASCO Annual Meeting May 29-June 2, 2015: Chicago, IL The American Society of Clinical Oncology Annual Meeting brings together 30,000 oncology professionals from around the world. Educational sessions feature worldrenowned faculty discussing state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field. Science sessions present the latest ground-breaking research in oral and poster format. You’ll meet friends and make connections, and bring back new ideas to your practices and hospitals. Take the time to familiarize yourself with the different opportunities the Annual Meeting offers. Mark key dates on your calendar, find out about networking opportunities, and learn about the committees that develop the session content you’ll discover onsite. The theme for ASCO 2015 is “Illumination and Innovation: Transforming Data into Learning.” Innovation—the imaginative and creative use of knowledge to transform how we improve the lives of patients in a sustainable and scalable manner—is the necessary companion to illumination. The transformation of data into knowledge, and knowledge into learning, enables us to move our health care delivery and research systems forward. Illumination and innovation are how the most adaptable will survive in a changing environment. As oncology professionals, we have always been and always will be at the forefront of creativity and disruptive change; it is the nature of who we are, and why we endeavor in this most difficult of medical specialties to illuminate the path forward. ASCO’s goal is not the accumulation of knowledge for its own sake, but rather the application of knowledge to patient care. With data as a shared resource, we can accelerate learning from one another and from our patients, sharing new insights and making faster strides against cancer. McCormick Place Convention Center 2301 S Martin Luther King Drive Chicago, IL 60616 For more information, visit: http://am.asco.org/
Chicago, Illinois
Event Visitor
Getting to Chicago: Chicago’s central location makes it easy for travelers to get there quickly. Most U.S. residents can drive to the city in one or two days, and those who prefer to fly can take one of the 2,900 daily flights to either the O’Hare International Airport or the Midway International Airport. O’Hare International Airport, located 17 miles from downtown, is one of the largest airports in the world. It is one of North America’s major international gateway airports, flying over 67 million passengers to and from over 200 destinations around the globe. Midway International Airport is located 10 miles from downtown Chicago and offers another convenient travel option for visitors. It is the nation’s premier point-to-point airport, offering valueoriented leisure and business travel to over 60 destinations. Both airports offer taxi service to the downtown area and the suburbs. Rates range from $40-50 from O’Hare and from $30-40 from Midway, although they may vary based on travel time and are subject to change. The Chicago Transit Authority serves both airports for easy and economical travel between downtown and Chicago neighborhoods using the “L” train. The 24-hour CTA Blue Line connects directly to O’Hare and the CTA Orange Line connects directly to Midway. Another option is GO Airport Express, which provides shared ride services to all downtown/suburban hotels and many businesses. Pair fares and group discounts are available along with customized reservation portals for your groups. Additionally, many major car rental companies have facilities at the O’Hare and Midway Airports, including Avis, Alamo, Budget, and Hertz. Please visit specific rental company websites for details. Limousine and chauffer agencies prefer that all customers reserve cars at least 48 hours in advance, although cars can occasionally be ordered with a two-hour notice.
Getting Around Chicago: Taxi: Taxis are plentiful and easy to hail downtown and at the airports, and offer a convenient way to get around the city. Credit cards are accepted in all cabs by city mandate. It is standard to tip the driver about 15-20% of the fare, plus $1-2 per bag if the driver helps you with luggage. Please note that all fares are subject to change.
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Chicago, Illinois
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Chicago Transit Authority (CTA): The CTA operates the nation’s second largest public transportation system—serving the city of Chicago and 40 neighboring communities by rail and bus. Pay cash for single-trip rides or purchase a reloadable Transit Card or Unlimited Ride Pass for added savings. For full fare information and maps, visit the Chicago Transit Authority website at transitchicago.com. Visitors may also opt to take one of Chicago’s eight “L” lines, which connect the city via above-ground, street-level, and subway trains. They serve 144 rail stations all over town, making it one of the most efficient and affordable methods of transportation available. Two lines operate 24 hours a day: the Blue Line, which connects the airport and downtown, and the Red Line, which offers service between the north and south sides of town. Additionally, more than 100 bus routes lace the city, with several lines operating 24 hours a day. Exact change is required for cash fare. Metra Commuter Rail: This train connects outlying suburbs to downtown and is a fast, easy way to get into the heart of the city. For exact fares and route maps, visit the Metra website at metrarail.com.
Weather in Chicago: From a spectacular winter wonderland to a stunning sun-splashed metropolis, you’ll find four seasons of fun and beauty in Chicago. Winters in the city come with chilly temps and numerous opportunities for snowy adventures. The average annual snowfall is 37 inches, and daily highs average between 30°F and 38°F. Springtime in Chicago means blooming flowers and a lively lakefront. Temperatures typically reach the 50s in April and then the 70s in May. Summers in Chicago are also warm, with average daytime temperatures around 85°F. Just note that June is typically the wettest month of the year, so make sure to bring an umbrella. Fall is a beautiful time of year to be in Chicago as the leaves turn and temperatures start to cool off. October is usually the driest month, and temperatures gradually drop from the mid-70s to the mid-40s as it gets closer to winter.
Chicago, Illinois
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Dining in Chicago: Recommendations for a Business Meeting Prosecco: This high-end Italian eatery offers gourmet comfort food from all 20 regions of Italy in an art-filled room reminiscent of the faded splendor of Venice. From house-made pastas to classic seafood dishes, Executive Chef Mark Sparacino fuses fresh ingredients with Old World recipes to create his menu of mouthwatering specialties. Prosecco also offers one of the largest selections of Italian sparkling wine in the city, making it easy to find a suitable pairing for your dish, whether it’s the spinach Gnocchi with Gorgonzola cream or the veal scaloppine with prosciutto di Parma and fresh mozzarella. Prosecco is open Monday through Friday for lunch and dinner and Saturdays for dinner only. 710 N Wells St., (312) 951-9500 La Scarola: Find a piece of Italy in Chicago at La Scarola, a cozy Italian restaurant serving up authentic fare. The eatery offers an extensive menu that features both contemporary and traditional Italian dishes, including eggplant parmigiana, clams Mondelli, lasagna, and veal Marsala. There is also a rotating specials menu with a few items that remain a stronghold, including the penne a la vodka with shrimp and asparagus. Just make sure that you come hungry—La Scarola is known for its heaping portions—and that you arrive early since the restaurant is often packed. If you have to wait, the restaurant has a full bar so you can enjoy a cocktail or a glass of wine until you are seated. The La Scarola is open for dinner seven days a week. 721 W Grand Ave., (312) 243-1740 Girl & the Goat: For a more casual meeting, head over to the Girl & the Goat, a local hotspot famous for its innovative small plates. This fun and funky restaurant is the brainchild and culinary home of “Top Chef” Season 4 winner Stephanie Izard, who uses Mediterranean flavors and local ingredients to create her unique dishes. While there is goat on the menu (including goat pizza with tart cherry soffrito), Izard serves up so much more. The restaurant’s menu is divided into vegetable, meat, and fish categories, with a total of 10 shared plates in each section. Though the offerings will change based on
Chicago, Illinois
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seasonality, you’ll be hard-pressed to find a dish that doesn’t sound delicious. And be sure to indulge in a dessert—Izard makes all her savory-sweet creations in-house, like frozen corn nougat and deconstructed Fudgsicles with olive oil gelato. 809 W Randolph St., (312) 492-6262
Quick Bites on a Budget Lou Malnati's Pizzeria: A popular pie place is the family-owned and operated Lou Malnati's Pizzeria, which is famous for its Chicago-style deep-dish pizzas. Founded by the son of Rudy Malnati—who was instrumental in developing the recipe for Chicago-style pizza—the eatery has become one of the area’s best-known local line of pizza restaurants. Each pie is made from scratch using the finest and freshest ingredients, such as hand-selected California vine-ripened tomatoes and fresh mozzarella from the same small dairy that has supplied the pizzeria for more than 40 years. The restaurant has also stayed true to the original recipe that was created in 1943, passing it down from generation to generation, so come experience these authentic Chicago-style pies which are unmatched in flavor and taste. 1120 N. State St., (312) 725-7777
Off the Clock: Navy Pier: For a dose of fun after a busy day, head over to Navy Pier, a 50-acre playground of museums, restaurants, parks, and attractions. The iconic 150-foot Ferris wheel offers stunning vistas of the city and Lake Michigan, as does the Crystal Gardens, a gorgeous one-acre botanical garden in a six-story glass atrium. During the warmer months, you can also take a bike tour of Chicago or see the city from the water on one of the many sightseeing boat cruises, all of which start at Navy Pier. But no matter what time of the year it is, there is always something happening at the pier. The fall is packed with Oktoberfest celebrations, firework shows, and art fairs, while the winter includes special events such as Winter WonderFest and Snow Days Chicago, both of which offer rides and activities ranging from snowboarding to snowshoeing to ice skating. 600 E. Grand Ave., (312) 5955282
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Chicago, Illinois
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The Art Institute of Chicago: Take pleasure in one of the nationâ&#x20AC;&#x2122;s finest and largest collections of Impressionist and Post-Impressionist art at the Art Institute of Chicago. The encyclopedic art museum encompasses more than 5,000 years of human expression from cultures around the world with works of art ranging from European decorative arts to Asian art to graphic design to American paintings. You can see pieces by Claude Monet, Henri Matisse, Pierre-Auguste Renoir, and Henri de Toulouse-Lautrec, as well as numerous other works by both legendary and lesser-known artists. Though there are more than 260,000 pieces of art to view, make sure to explore the architecturally stunning Modern Wing, which holds an impressive assortment of modern and contemporary art, including paintings by Pablo Picasso and original renderings by Frank Lloyd Wright. 111 S. Michigan Ave., (312) 443-3600 After 5 PM: For a night out on the town, head to one of the many wine bars, cocktail lounges, taverns, or dance clubs. The Wrigleyville area in Lakeview is always bustling, as is nearby Boystown. The main intersection of North, Milwaukee, and Damen Avenues in Wicker Park is also filled with trendy destination hotspots, such as the Double Door and the Violet Hour. For some laughs, head to the North Side neighborhoods, which have a mix of comedy clubs, including Zanies and the famed Second City in Old Town.
Per Diem Rates as of March 2015: The following rates apply for Chicago, Illinois Primary Destination*
County
Chicago
Cook / Lake
Max Lodging by Month (Excludes Taxes) Mar
Apr
May
Jun
159
159
192
192
Meals & Inc. Exp. ** 71
* NOTE: Traveler reimbursement is based on the location of the work activities and not the accommodations, unless lodging is not available at the work activity, then the agency may authorize the rate where lodging is obtained. ** Meals and Incidental Expenses, see Breakdown of M&IE Expenses for important information on first and last days of travel.
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