Austin Medical Times News by Rick Delarosa

August Edition 2019

Inside This Issue

Web of Laws Affect Data Sharing

Researchers Highlight Legal Obstacles in Cross-Sector Data Sharing to Improve Public Health Research While Protecting Subject Privacy By Rae Lynn Mitchell

T Life-Threatening Genetic Cholesterol Condition Could Be Found Through Blood Donations See pg. 8

INDEX Financial Forecast............. pg.3 Legal Matters....................... pg.4 Oncology Research......... pg.6 Mental Health...................... pg.7 Healthy Heart..................... pg.10

St. David’s South Austin Medical Center Names New Chief Nursing Officer See pg. 9

he recent decades have brought exponential growth to the amount of data collected on virtually every person. This is apparent in public health research, which has steadily grown its reliance on data analysis to correctly identify and address problems. However, sharing data across different sectors, ranging from health care systems to state and local governments, can be challenging thanks in part to an inconsistent and often confusing framework of legal protections. In a new paper published in the Journal of Law, Medicine and Ethics, Cason Schmit, JD, research assistant professor in the Health Policy and Management Department at the Texas A&M School of Public Health, joins colleagues in describing some of the legal obstacles facing cross-sector data sharing. The paper also examined how one data-sharing effort overcame some of these challenges to get a clearer view how mental health care issues affect the community and improve delivery of necessary services. Additionally, Schmit and colleagues highlight the need for a new legal framework that can facilitate helpful data sharing while protecting the privacy of everyone involved. Cross-sector data sharing can be challenging because data are protected by laws at both the state and federal level that provide varying levels of protection depending on the type of data in question, how it was collected, who controls it and what the intended use of the data is. Such laws are in place mainly to protect the privacy of those in the data, and, as such, many laws focus on identifiable data. However, an analysis noted that 22 separate federal laws had differing standards for identifiable data, with

some only focusing on direct identifiers such as names and others concerned with information that could be connected to an individual as well.

comprehensive framework that clearly authorizes public health and research use would be beneficial for public health efforts to build a healthier population. However, despite the limitations presented by the morass of laws and lack of a clear legal framework, researchers have successfully used cross-sector data sharing to identify and address public health issues. In 2016, three county health departments in Illinois—Peoria, Tazewell and Woodford counties—developed a data-driven plan to reduce substance abuse and improve mental health. The research team was able to overcome legal barriers and address varying protection levels by sending data from different sources to the Peoria Health Department, which handled the data. Through these processes the researchers were able to discover trends in mental health and substance abuse issues related to health care,

Schmit and colleagues highlight the need for a new legal framework that can facilitate helpful data sharing while protecting the privacy of everyone involved. These inconsistencies, and similar ones at the state level, can lead data owners to err on the side of caution and strip more data than might be necessary. Another obstacle in data sharing is the frequent absence of specific language authorizing the use of data for research purposes. Of the 22 laws analyzed, only four had public health exceptions and 13 allowed at least limited research use of data. Thus, a

see Data Sharing... page 14

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Financial Forecast Recent Settlement with OCR and New OCR Fact Sheet Serve as Reminders That Business Associates Have Direct Liability under HIPAA By Thora A. Johnson, Jami Mills Vibbert & Judy Kim of the law firm Venable

he Department of Health and Human Services Office for Civil Rights (OCR) has shown once again that it is willing to enforce HIPAA against business associates, as seen in a recent settlement. The settlement highlights the importance of thorough risk analysis conducted by business associates and covered entities, as required by the HIPAA Security Rule, and serves as an indication that OCR remains ready to exercise its authority to enforce HIPAA’s requirements for business associates. Following the settlement, OCR released a fact sheet that provides guidance for HIPAA compliance and direct liability for business associates. Recent Settlement On May 23, 2019, OCR announced a settlement with a business associate relating to a 2015 data breach. The business associate provides software to healthcare providers that allows

patients to access and manage their electronic health records through a patient portal. The company has agreed to pay OCR $100,000 to settle potential violations of HIPAA. In July 2015, the company filed a breach report with OCR following discovery that hackers had used a compromised user ID and password to access the electronic protected health information (ePHI) of approximately 3.5 million individuals. The hackers gained access to a server containing names, addresses, usernames, passwords, and health insurance information. An investigation by OCR revealed that the company did not conduct a comprehensive risk analysis prior to the breach. In addition to a $100,000 settlement with OCR, the company will also undergo a two-year corrective action plan that includes a complete, enterprise-wide risk analysis. As part of the corrective action plan, the company has agreed to: • Conduct a comprehensive risk analysis of “the potential risks and

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v u l ner abi lit ie s to the confidentiality, integrity, and availability” of the company’s ePHI within 30 days of the effective date of the OCR settlement. OCR specified that the company’s risk analysis shall include an inventory of its facilities and categories of electronic equipment, data systems, and applications that create, receive, transmit, or maintain ePHI; • Develop and implement a written risk management plan to address and mitigate security risks and vulnerabilities identified in the risk analysis; and • Provide annual reports to OCR of its compliance efforts with respect to the action plan. In addition to OCR enforcement, the company has been the subject of the nation’s first multistate lawsuit against business associates involving a HIPAA-related data breach. On the same day as the OCR settlement announcement, the company also

settled a lawsuit brought by 16 U.S. state attorneys general regarding the same breach. The company has agreed to pay $900,000 to resolve the multistate action over alleged HIPAA violations related to the 2015 data breach. The lawsuit was filed in December 2018, alleging the company had violated HIPAA, state unfair and deceptive acts and practices laws, data breach notification statutes, and personal information protection laws. The 16 state attorneys general named as plaintiffs in the lawsuit included Arizona, Arkansas, Connecticut, Florida, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Nebraska, North Carolina, Tennessee, West Virginia, and see Financial Forecast...page 14

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Legal Matters

faith attempts to receive in-patient or out-patient services from in-network facilities, they are unnecessarily held financially responsible because of the everlasting reimbursement disputes between health insurers and health care providers. In recognition of the stress these surprise medical bills induce, the Texas Legislature passed a bipartisan bill that, when signed into law, will prohibit surprise medical bills from

Insurance (“TDI”) describes a surprise medical bill (i.e a balance bill) as a bill from a doctor, hospital, or other health care provider who is not a part of the insured’s network, and provides the following example: A patient goes to an in-network hospital for emergency care and is treated by an out-of-network doctor. The doctor and the hospital each bill $1,000 for their services, and the health plan [insurer] pays them each $400. The in-network hospital can only bill the patient for copays, deductibles, and coinsurance amounts. The doctor, however, may bill [the patient] for the $600 that

being sent to patients and force payers and providers to resolve these disputes, in good faith, on a claim-by-claim basis. The Texas Department of

the health plan [insurer] didn’t pay, as well as any copays, deductibles, and coinsurance. Unsuspecting patients had

Texas Passes Consumer Protection Law on Surprise Medical Bills

By Ebad Khan, JD Lauryn Sanders, JD

riven Governor Abbot recently signed Senate Bill 1264 which, effective September 1, 2019, provides consumer protections against certain medical and health care billing by certain out-of-network (“OON”) providers. Surprise medical bills have become a familiar life event for residents of the state of Texas. Either in instances of medical emergencies where Texans are left with no other option but to receive OON medical attention from providers or when Texans unknowingly receive OON ancillary services (e.g. lab or imaging services) despite their good

previously been saddled with this OON bill because either the insurer underpaid the provider, the provider’s billed amounts were too high, or a combination of both. With the passage of Senate Bill 1264 earlier this year, the Texas legislature took it upon itself to ensure that Texans are no longer left feeling exploited by this practice. Once effective, Texans receiving health care services from OON providers in the above mentioned instances will no longer be responsible for any amounts greater than their cost-share obligations (i.e. copay, deductible, coinsurance). Upon the processing of a claim, the patient’s insurer must include in the explanations of benefits a statement on the prohibition of balance billing the patient and the total amount the provider may bill the patient with an itemized breakdown of the patent’s cost-share obligations. Furthermore, in the event an amount on a OON claim, less the patient’s cost-share obligations, remains outstanding, either the OON provider or the insurer has the option to request a mandatory mediation or a mandatory arbitration of the claim through the see Leadership...page 12

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Oncology Research Fighting Fear Itself and Finding the Courage to Seek Support During Cancer By Mathew Meeneghan, M.D., Texas Oncology South Austin

o Bewilderment. Confusion. And perhaps most of all, fear. All of these feelings can accompany a diagnosis of cancer, one of life’s most uninvited and unwelcome challenges. But there’s also a certain kind of lonely fear. A sense that this is your challenge. That only you can fight your fight. Overcoming that isolated fear and asking for help when you need it itself is an act of courage. For some, it means showing vulnerability during a time when they want to be strong for themselves and those around them. The truth is cancer patients almost always

patients say their family members and friends are busy, and they don’t want to interfere with their lives. The response from loved ones is almost always that they want to provide this much-needed support – whether it’s helping clean or cook meals, providing transportation to and from appointments, or listening and being a source of emotional support. Everyone has different ways of facing their fears, but many patients and their loved ones cope best with all that cancer involves when they face it together. Find support groups and seek others with shared experiences. It’s true that every patient’s cancer journey is unique. But cancer patients also share a common and profound life experience. That’s why support groups that allow you to share with those who also have been through it are helpful. Bringing patients together

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benefit from seeking and accepting support. Following are considerations for reaching out for assistance. Open the lines of communication from the beginning. The first step in overcoming fear is communication. Communicating with your care team and loved ones allows for honest dialogue around your fears to help you overcome them. Don’t wait to talk about how you’re feeling. Communicate early and often. It can help you better understand your diagnosis, treatment and side effects, and outcomes. Communication can positively impact your experience as a patient. Learn to accept support from those close to you. Having cancer affects you and those around you. Common concerns among patients are the fear of burdening others and asking for help. We hear

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to address cancer-related concerns can be cathartic, whether discussing fear of recurrence or finding a new normal during and after cancer treatment or other issues. The groups are often led by current or former patients and may be focused on specific cancer types. Texas Oncology provides resources on support services for patients and caregivers, as does the American Cancer Society and the National Cancer Institute. You can also talk to your cancer care team about getting connected to the right resources for you and your family. Keep in mind this kind of exchange is two-way. Seeking support from those who have experienced similar things may help you cope with your fears. In turn, you may positively impact other patients by sharing your story. see Oncology Research...page 14

Austin Medical Times

Mental Health Unveiling Brain Circuits That Control Addiction Connections in The Brain’s Striatum Point to Possible Therapeutic Targets To Curb Addictive Behavior By Vandana Suresh

common distress among people who are addicted is the pressing urge to acquire their substance of abuse, be it alcohol or drugs. Thus, targeting connections in the brain that coordinate compulsive behaviors could be a solution to overcoming these intense cravings. Using alcohol as addictive agents for animal models, Texas A&M researchers have recently discovered a microcircuit in a brain region called striatum that might regulate the drive towards excessive alcohol consumption. They reported their findings in the journal Neuropsychopharmacology earlier this year. The striatum is part of a larger pathway in the brain that controls voluntary movements. Nerve endings from the midbrain supply the striatum with copious doses of a neurochemical called dopamine that is a major player in addiction. Studies show that

exposure to addictive substances like alcohol can alter dopamine function and affect the normal working of this dopaminergic pathway. “Addictive substances can highjack the brain’s dopaminergic system,” said Jiayi (Ada) Lu, MD, graduate student at Texas A&M College of Medicine and primary author of the study. “If these substances are used continuously, they can increase dopamine levels in the brain high enough to cause addictive behaviors.” Specialized cells called medium spiny neurons (MSNs) make up most of the striatum. They either express the D1 or D2 type of dopamine receptors. D1 MSNs initiate goal-directed movements or behaviors via the “go” pathway whereas the D2 MSNs inhibit the same movements or behaviors via the “no-go” pathway. Hence, MSN-regulated pathways have been implicated in behaviors related to addiction.

Also, MSNs receive connections from many parts of the brain including the cortex. Much like the volume knob on a radio can change the intensity of sound but not its tone, dopamine via their receptors can turn the connection strength (or synaptic strength) between MSNs and their cortical inputs up or down to influence drinking behavior. In particular, experimentally enhancing synaptic strength between cortex and D1 MSNs increases alcohol-seeking behavior in animal models. By influencing the way dopamine is regulated in the striatum, addictive substances can also alter connection strength between cortical inputs and D1 MSNs, however, the mechanisms are unknown. Lu’s study addresses this research gap by zooming into cortical-MSN synapses that are enriched with dopamine receptors. “I hoped to dissect the cortical-MSN synapse based on dopamine receptor expression, patterns and combinations,” she said. Using a combination of optogenetics and transgenics, she found that even in animal models that were teetotalers, synaptic strength between

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D2-expressing cortical inputs and D1 MSNs were naturally stronger than all other dopamine receptor-expressing cortical-MSN connections. Furthermore, in alcoholic animal models, this “D2-D1” connection was further strengthened suggesting that alcohol was influencing this circuit more than others. According to Lu, her findings have direct biological relevance in addictive behaviors: “Excessive alcohol consumption particularly affected the strongest (D2-D1) synapses which is an interesting result because it makes sense at the behavioral level,” she said. “They kind of promote the go pathway, and as a result, people with alcohol use disorder cannot really stop recurrent drinking.” see Mental Health...page 14

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Life-Threatening Genetic Cholesterol Condition Could Be Found Through Blood Donations By Lori Sundeen Soderbergh

hat if your blood donation held clues to a dangerous genetic cholesterol condition that could also affect the health of your loved ones? Cardiologists know that familial hypercholesterolemia (FH), a condition that causes extremely high levels of cholesterol at an early age, is genetic. When one person is diagnosed, other family members can be identified. However, only an estimated 10 percent of those with FH are diagnosed, leaving many others at risk. “For someone with FH, the risk of heart disease is higher because their clock started early. They’ve been bathed in high cholesterol since birth. At the same time, they may not know their kids are at risk,” said preventive cardiologist Dr. Amit Khera, Principal Investigator for the study and Professor of Internal Medicine at UT Southwestern Medical Center. “Sometimes by identifying one patient with FH, we find as many as eight or 10 more family members who

are at risk.” The study published in JAMA Cardiology concludes that blood donation programs represent a unique opportunity as a public health portal to screen for diseases such as FH. According to the American Association of Blood Banks (AABB), approximately 6.8 million people in the U.S. donate blood every year, and 32.3 percent are first-time donors. Up to 1.2 million people in the U.S. are estimated to have FH. If children are suspected to have the disease FH based upon their family history, then testing for FH begins at age 2. The standard treatment is diet and exercise, followed by the addition of statins in later childhood. Statins are a product of Nobel Prize-winning research on FH led by esteemed UT Southwestern molecular geneticists in the 1980s. People who are at risk must first be identified in order to receive treatment. Dr. Khera decided to try

examining blood donation records to find people who appear to have FH, but are less likely to see a doctor or receive statins. “Blood donors are young, healthy, and may have less necessity to see doctors regularly,” said Dr. Khera, who holds the Dallas Heart Ball Chair in Hypertension and Heart Disease. His team worked closely with Carter BloodCare in Dallas to review 1,178,102 individual blood donation records. They found 3,473 people who met criteria for FH based on

their cholesterol levels, similar to the estimated prevalence in the general population. It was more common in blood donors under the age of 30, and for men versus women. There was no significant difference by race except for Asian donors who had a slightly higher prevalence. The UT Southwestern cardiology team plans to develop a

see Cholesterol...page 9

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St. David’s South Austin Medical Center Names New Chief Nursing Officer

t. David’s South Austin Medical Center has named Ulondia Lee as its new chief nursing officer (CNO), succeeding Sally Gillam, who retired in April after serving 30 years in that role. “With more than 20 years of leadership experience in coordination of patient care, quality, efficiency improvement and managing clinical operations with fiscal responsibility, I am confident that Ulondia will serve as a valuable member of our leadership team,” David Huffstutler, president and chief executive officer of St. David’s HealthCare, Ulondia Lee said. Lee, who assumed her new role on April 8, served as CNO at Metropolitan Methodist Hospital, a 354-bed, full-service acute care hospital in San Antonio, for three years. In that role, she had direct oversight of all facility nursing operations, and she established a nursing strategy to support the hospital’s long-range goals, including operational efficiencies, volume growth, physician relations and employee engagement. Prior to her role as CNO at Metropolitan Methodist, Lee served as vice president of clinical nursing and director of medical-surgical

services, as well as coordinator of the hospital’s Magnet Program. Throughout her nursing career, Lee has held several nursing leadership positions, including medical-surgical assistant director at North Hills Hospital in North Richland Hills near Fort Worth, as well as nursing administrative supervisor at Osteopathic Medical Center in Fort Worth. Previously, she worked as a nurse in various departments at King’s Daughters Hospital in Greenville, Mississippi..

Cholesterol

Continued from page 4 process for following up with people who are identified, connecting them with the appropriate medical care including family screening, and to continue studying the effectiveness of these interventions. Anyone with a cholesterol level higher than 200 should see a physician for review of their family history, a full cholesterol panel (blood test), and a physical exam. The exam can identify

the disease through visible signs such as cholesterol deposits in tendons, called xanthomas. “The blood donor screening program could be a novel strategy to detect and notify people with potential FH, particularly younger people in whom early detection and treatment is especially impactful, as well as to guide screening of family members,” said Dr. Khera.

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Healthy Heart Protect Your Heart in The Heat By American Heart Association

t has been a hot summer, so the American Heart Association is urging people to take precautions to protect their hearts. While infants and the elderly are more vulnerable to problems from heat, extreme temperatures can be hard on the heart. Dehydration causes the heart to work harder, putting it at risk. Hydration helps the heart more easily pump blood through the blood vessels to the muscles and that helps the muscles work efficiently. “If you’re a heart patient, older than 50 or overweight, you might need to take special precautions in the heat. Certain heart medications [can] deplete the body of sodium, exaggerate the body’s response to heat and cause you to feel ill in extreme heat,” said Robert A. Harrington, M.D., FAHA, president of the American Heart Association and the Arthur L. Bloomfield professor of medicine and chair of the Department of Medicine at Stanford University.

Remember to talk to your doctor about any concerns. The American Heart Association suggests that everyone take these hot weather precautions: • Watch the clock: It’s best to avoid the outdoors in the early afternoon (about noon to 3 p.m.). • Get off on the right foot: Choose well-ventilated shoes and look for socks that repel perspiration. • Dress for the heat: Wear lightweight, light-colored clothing in breathable fabrics. Add a hat and sunglasses. Wear a waterresistant sunscreen with at least SPF 15. • Drink up: Drink a few cups of water before, during and after your exercise. Avoid caffeine or alcohol. • Take regular breaks: Find some shade or a cool place, stop for a few minutes, hydrate and start again • Follow the doctor’s orders: Continue to take all medications as prescribed. Watch for these signs and symptoms of

heat exhaustion: • Headaches, dizziness or fainting (syncope) • heavy sweating • cold, moist skin, chills • a weak and rapid pulse • muscle cramps • fast, shallow breathing • nausea, vomiting or both Watch for these signs and symptoms of heat stroke (which is not the same thing as a stroke): • warm, dry skin with no sweating

• strong and rapid pulse • confusion and/or unconsciousness • high fever • throbbing headaches • nausea, vomiting or both If you experience these symptoms, seek medical attention right away. Learn more about heat exhaustion and heat stroke by visiting https://www. heart.org/en/news/2018/07/20/protectyour-heart-and-health-during-the-dogdays-of-summer

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VA Telestroke Program Improving Care for Veterans Improving Veteran Access to Emergency Stroke Care

mergency stroke care for Veterans continues to improve thanks to the expansion of VA’s National Telestroke Program, one of the first nationwide telestroke programs in the world. The program was launched in 2017 to improve Veteran access to stroke specialists. “In just two short years, the VA National Telestroke Program has grown to provide acute stroke services in over 30 VA medical centers from coast to coast,” said Dr. Glenn Graham, VHA Deputy National Director of Neurology. “We’ve built an extraordinary team of over 20 stroke neurologists across the United States, united in their passion to improve the care of Veterans in the first hours after stroke. “We’ve developed new technological tools dedicated to the task, such as the Code Stroke mobile app, and have improved the consistency and quality of stroke care in VHA nationally.” Stroke is the fifth leading cause of death in the United States and the leading cause of serious longterm disability. When it comes to stroke, time is brain! During a stroke, 1.9 million brain cells die every minute. Delaying treatment one-hour ages the brain 10 years. Treatment of stroke with a clotbusting drug reverses the effects of a stroke and reduces long-term disability. Having a stroke neurologist readily

available to guide treatment improves outcomes for stroke patients. However, emergency access to a stroke neurologist 24/7/365 is often limited. Telestroke solves this problem Telestroke go-live training at the VA Medical Center by using technology to bring a stroke neurologist to a patient’s bedside stroke neurologists from around the country. “It’s the ability to serve anywhere in the country in seconds. In minutes, stroke victim talking to Veterans in a new way and to serve Veterans that otherwise wouldn’t get neurologist via video The VA program uses an that care, bringing a new service to innovative approach to providing those areas. It’s been really gratifying,” services by using low-cost, highly- said a VA telestroke neurologist. The reach of the program will reliable commercial technology: extend beyond VA with the upcoming iPads. When a patient has stroke symptoms, the telestroke neurologist worldwide release of the Code Stroke initiates a FaceTime video call to the App. The VA-developed app scheduled iPad at the patient’s bedside and has for release this summer will be free to a live conversation with the patient, users worldwide. The app is designed to caregiver, and on-site providers. The be used during a stroke code to reduce neurologist examines the patient, time-to-treatment by providing realreviews the medical record, and guides time information to all team members regardless of location. treatment. “The Code Stroke app focuses In the first two years of on accelerating the episode of acute operation, the program has conducted over 1,000 emergency consults and care by organizing and managing feedback has been overwhelmingly the repetitive aspects of care while positive. “Specialty doctors, really good providing decision support, structured between neurologist ones, are not able to be in every place interaction at every time. We had a way to connect and ICU/ER staff, and automatic the doctor with me when I needed it,” documentation,” said William Cerniuk, Director of VA’s Mobile Program. said one Veteran. The program has attracted Need for quick expert decision is

critical “While our initial focus was on small, rural VA medical centers with little or no specialty care in neurology, it is clear that even large, urban VA hospitals can benefit from participating in the VA Telestroke Program,” said Dr. Graham. “This is really no surprise, as with the increase in stroke treatment options, the need for expert decision making at the bedside and without delay is greater than ever. I can imagine a time when all VAs not having a resident or attending neurologists in the hospital at all times will use telestroke to fill these gaps. There is much exciting room for growth, and much important work to be done.” Call 9-1-1 right away if you or someone you are with shows any signs of a stroke, such as the abrupt onset of weakness, numbness, vision loss, difficulty speaking or understanding, or loss of coordination. Act FAST!

Legal Matters

Continued from page 4 TDI’s website. If mediation is requested, a mediator will have the discretion to adjust an amount to be paid to the provider if the mediator believes more should be paid on the patient’s OON claim. However, if arbitration is requested, then each party will submit the amount it believes to be

August 2019

paid (i.e. billed amount for provider and allowed amount for insurer) and the arbitrator, after reviewing the supporting documents provided from each party, will determine one of the submitted amounts as the final award. The arbitrator will not have the discretion to make any adjustments on the amount to be paid. This style of

arbitration is commonly referred to as “baseball” style arbitration. By the passage of this law, Texas has positioned itself to become one of the more patient friendly states by shielding its residents from the practice of surprise billing, and has created a pathway for all other states to follow. Of important note, this law only

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applies to insurance plans that are regulated by the State and TDI -which represent less than a quarter of the health insurance sold in Texas. The law does not apply to other types of health insurance plans that are not regulated by the TDI including self-funded employee benefit plans.

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Data Sharing

Continued from page 1 public health and law enforcement and emergency services groups. Their findings confirmed that a small number of people were involved in a disproportionately large number of cases, which enabled targeted interventions to help those people. Such improved interventions not only promise improved public health, but also stand to decrease public spending in the form of hospitalization or

incarceration. This effort shows what can be accomplished through sharing data across sectors and highlights the hard work and dedication of those involved in the two-year project. Such a success provides a concrete example of how useful data sharing can be. However, the legal obstacles the research team had to negotiate also point to the need for legal frameworks that can help

researchers share data across sectors to improve their research while protecting subject privacy. “As the volume of data collected on each of us continues to grow, and as data analysis becomes more sophisticated, such cross-sector work will likely become more common and necessary, further adding to the call for such a framework,” Schmit said.

Financial Forecast with OCR investigations; 2. Taking retaliatory actions against individuals for filing a HIPAA complaint; 3. Failure to comply with HIPAA Security Rule requirements; 4. Failure to provide a breach notification to a covered entity or another business associate; 5. Impermissible uses or disclosures of PHI; 6. Failure to fully comply with HIPAA’s right of access to PHI in a readily available form and format; 7. Failure to make reasonable efforts to limit access to PHI to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request; 8. Failure to provide an accounting of disclosures in certain circumstances; 9. Failure to enter into HIPAA-compliant downstream business associate agreements (BAAs); and 10. Failure to take reasonable steps to address a breach or violation of a downstream BAA. The guidance also notes that, by contrast, OCR lacks authority to enforce the “reasonable, cost-based fee” limitation in 45 C.F.R. § 164.524(c)(4)

against business associates, because the HITECH Act does not apply the fee limitation provision to business associates. A covered entity that engages the services of a business associate to fulfill an individual’s request for access to his or her PHI is responsible for ensuring that, where applicable, no more than the reasonable, cost-based fee permitted under HIPAA is charged. If the fee charged is in excess of the fee limitation, OCR can take enforcement action only against the covered entity. It is important to note, however, that a business associate may have contractual obligations to the covered entity to comply with such limitations, thus shifting the burden to the business associate. The Takeaways Business associates should conduct thorough, annual risk assessments. Risk assessments are required under the HIPAA Security Rule and can lead to protection from arguments that safeguards in place at the time of an incident or otherwise were inadequate. In addition, business associates should keep in mind their direct liability for HIPAA violations when negotiating liability shifting provisions in their business associate agreements.

Oncology Research Continued from page 6 There is nothing to fear when it comes to seeking and accepting the support of others. Whether it’s through your cancer care team, loved ones, or

your local community – leaning on others can greatly enrich your cancer journey. At Texas Oncology, we work tirelessly to ensure our patients never

face cancer on their own. Ensuring each patient is supported is a part of our commitment to caring for the whole patient.

If so, inhibiting the D2-D1 circuit may help curtail addictive behaviors in general. “We hope that in the future, our results on the striatal D2-D1 circuit

will contribute to identifying new therapeutic targets for addiction,” she said.

Mental Health

Continued from page 7 Lu noted that D2-D1 connections may not be affected only by alcohol, and it is possible that this circuit is influenced by other addictive drugs. August 2019

Director of Media Sales Richard W DeLaRosa Senior Designer Jamie Farquhar-Rizzo Web Development Lorenzo Morales

Continued from page 3 Wisconsin. In addition to the payment of $900,000, the agreement requires the company to implement multiple privacy and cybersecurity safeguards, such as the designation of a privacy officer and the implementation of multifactor authentication to access any personal health information. The respective settlements evidence that business associates may be held liable for HIPAA compliance not only by OCR, but also by state attorneys general. Confirmation of Direct Liability under HIPAA for Business Associates On May 24, 2019, OCR issued a fact sheet on the Direct Liability of Business Associates under HIPAA. Consistent with the Health Information Technology for Economic and Clinical Health (HITECH) Act and OCR’s 2013 final rule, the fact sheet provides an important reminder to covered entities and business associates regarding the circumstances in which OCR can and cannot take enforcement actions directly against business associates for violations of HIPAA regulations. The fact sheet identifies 10 categories of HIPAA violations for which a business associate may be directly liable: 1. Failure to provide records and compliance reports in cooperation

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