HOUSTON
Oncology Research pg.3
Mental Health ..................... pg.5
Healthy Heart pg.6
The Framework ................... pg.7
Financial Forecast pg.12
FDA Finalizes Rule Regulating Laboratory Developed Tests
TheFDA recently issued a Final Rule to phase out its general enforcement discretion for most Laboratory Developed Tests (LDTs). The Final Rule amends FDA regulations to explicitly classify LDTs as in vitro diagnostic products (IVDs) that are regulated as devices under the Federal Food, Drug, and Cosmetic Act. It implements a four-year phaseout policy, divided into five stages, that will require all IVD manufacturers to meet the same device requirements unless the test meets a specific enforcement discretion policy.
The Rule is set to significantly reshape the regulatory landscape for LDTs, with far-reaching implications for manufacturers, patients, and healthcare providers. Hospital systems that have integrated laboratories performing specialized LDTs will need to review the Rule to understand how these tests may be subject to additional regulatory requirements.
We expect stakeholders to challenge the Final Rule in court, arguing that it exceeds FDA’s statutory authority. This legal battle could shape the future of LDT regulation or prevent the Final Rule from being fully implemented. Additionally, Congress may renew its efforts to establish a legislative framework for LDTs.
With the Final Rule, FDA is hitting the reset button on IVD regulation to regulate all IVDs, including LDTs, similarly. For example,
the Final Rule applies to all “IVDs offered as LDTs” regardless of whether the test meets the traditional definition of an LDT, e.g., an IVD that is designed, manufactured, and used within a single laboratory. In broadening the scope, FDA is suggesting that not all laboratories have understood the limited nature of FDA’s enforcement discretion and that FDA perhaps has not been strictly enforcing its policies regarding LDTs.
FDA Enforcement Discretion
FDA intends to continue to exercise enforcement discretion for all or some applicable device requirements consistent with FDA’s general priorities.
• Exempt From all Applicable Requirements: FDA intends to apply its enforcement discretion to all regulatory requirements such as registration and listing, premarket review, and quality system (QS) regulations for the following tests: “1976 Type” LDTs with certain characteristics, e.g., use of manual techniques using components legally marketed for clinical use
Human Leukocyte Antigen Tests
− Tests for Forensic Law Enforcement Purposes
LDTs manufactured within the Department of Defense or Veterans Health Administration
• Exempt from Premarket Review Requirements: LDTs approved by the New York State Clinical Laboratory Evaluation Program are exempt from premarket review requirements.
• Exempt from Premarket and Quality System Regulations (Except for Part 820, subpart M (Records)): Other regulatory requirements, such as registration and listing, MDR requirements, and corrections and removals, must be followed in accordance with the phaseout timeline: LDTs manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system. FDA considers an unmet need to be one where there is no available FDA-authorized IVD that meets the patient’s needs. FDA is instituting this policy because the Agency recognizes that the cost of compliance with these
Memorial Hermann and Houston Community College Make It Easier for Employees to Attend Nursing School
Houston Methodist Clear Lake Hospital
By Suzanne Bassett, J.D.
Michael Gaba, J.D. Polsinelli, PC
Join 250,000+ professionals who get free Continuing Medical Education (CME) with Texas Health Steps Online Provider Education. Choose from over 50 CME courses developed by trusted Texas experts, for experts like you. Quick courses and case studies on topics such as Medicaid guidelines, ethics and mental health, and more are all available 24/7.
Oncology Research Five Strategies for Men to Combat Their Cancer Risk Today
ABy Miguel Mercado, M.D., Texas Urology Specialists–The Woodlands
ccording to the Centers for Disease Control (CDC), men have a higher rate of getting and dying from cancer than women. Among the ten top cancer types in U.S. men in 2024, an estimated 1,029,080 new cases will be diagnosed, and 322,800 men will die. This is why it is so important for men to take proactive steps to safeguard their health.
Here are five strategies men can implement today to reduce their risk of cancer and promote overall wellness and well-being:
1) Prioritize Regular Screenings
Screenings are essential for detecting cancer in its early stages, when treatment is most effective.
While these screenings may not always prevent cancer, they can detect abnormalities early on, allowing for timely intervention and potentially life-saving treatment.
Prostate cancer
Statistics show that prostate cancer remains one of the most prevalent cancers among men in 2024, with an estimated 1 in 8 men being diagnosed during their lifetime. Prostate cancer screenings typically involve a prostate-specific antigen (PSA) blood test beginning at age 45 and a digital rectal exam.
New guidelines for prostate cancer screenings for Black men now recommend starting annual PSA screenings at age 40. According to researchers with the Prostate Cancer Foundation, lowering the recommended age for baseline PSA to 40, along with regular screening intervals until the age of 70, could reduce prostate cancer deaths by about 30% in Black men. Colorectal cancer
Colorectal cancer follows closely behind prostate cancer, with the overall lifetime risk of men developing colorectal cancer being about 1 in 23. However, survival rates are significantly improving, which can be attributed to an increase in screenings.
Colonoscopies can prevent colorectal cancer through the detection and removal of precancerous growths at an early stage when treatment is usually more successful. For those at average risk, colonoscopies are recommended beginning at age 45. Those at a higher risk with a family history of colorectal cancer or polyps should consult with their doctor to determine the appropriate age to begin
colorectal cancer screening. Skin cancer
Per the American Academy of Dermatology Association, by age 50, men are more likely than women to develop skin cancer. This number rises by age 65, with men two times as likely as women of the same age to develop melanoma. Yearly skin checks can help detect and remove precancerous growths, and if necessary, treat skin cancer at its earliest and most treatable stage.
2) Maintain a Healthy Diet and Weight Eat a balanced diet of fruits,
Transformative Healthcare Innovations Across the TMC: A Symposium on Engineering and Medical Science
By Krystel G. Johnson and Shadia Sadaqa
Amidstthe renowned corridors of the Texas Medical Center (TMC) in Houston, Texas, a symphony of transformative healthcare innovation unfolded. On May 3, 2024, the Texas A&M School of Engineering Medicine (EnMed) orchestrated a symposium within the architectural marvel of TMC3 Helix Park Collaborative Building, converging leading luminaries to illuminate the nexus of cutting-edge medicine and engineering.
Dr. Roderic Pettigrew, Inaugural Dean of Texas A&M University School of Engineering Medicine, commenced the proceedings by articulating the imperative of collaborative synergy within the TMC ecosystem. Echoing this sentiment, Dr. Bernard A. Harris, Board Member of TMC,
accentuated the fertile ground for innovation cultivated within TMC’s collaborative framework.
The inaugural keynote by Dr. Harvey Fineberg, esteemed from the Gordon and Betty Moore Foundation, and former president of the National Academy of Medicine, underscored the imperative of interdisciplinary approaches in addressing contemporary medical challenges, laying the foundation for a cascade of enlightening discussions.
Pioneering endeavors were showcased, including Dr. Katy Rezvani’s breakthroughs in engineering natural killer (NK) cells for cancer therapeutics at MD Anderson Cancer Center, and Dr. Brendan Lee’s exploration of genome sequencing’s transformative potential in personalized medicine at Baylor
College of Medicine.
Subsequent sessions delved into a diverse array of topics, ranging from noninvasive cardiovascular imaging to mRNA nanotherapeutics and gene editing for sickle cell disease, showcasing the breadth and depth of TMC’s commitment to medical innovation.
The afternoon segment continued the intellectual odyssey,
with Dr. Gang Bao of Rice University illuminating advances in gene editing for sickle cell disease, Dr. Omid Veiseh exploring the frontier of immunoengineering and cell therapies, and Dr. Cynthia Hipwell of Texas A&M University unveiling the evolution of remote physical exams, epitomizing how technology enhances
Inside the architecturally stunning TMC3 Helix Park Collaborative Building, from left to right: Dr. Bernard Harris, Dr. Rory Cooper, Dr. Harvey Fineberg, and Dr. Roderic Pettigrew gather at the Transformative Healthcare Innovations Across the TMC Symposium, exploring the dynamic intersection of medicine and engineering.
see TMC ...page 14
Mental Health Three Buddhist Concepts to Practice Today
By Michael Jones Ph.D
In the bustling marketplace of modern life, three Buddhist concepts stand out as serene sanctuaries we can step into any moment, transforming our day with peace and mindfulness. These ancient teachings, far from being relics, are as relevant today as ever, offering us tools to navigate the complexities of our lives with grace and composure.
First up, Mindfulness: This is about being fully present in the moment, observing our thoughts, feelings, and sensations without judgment. Imagine treating each moment as if it were a precious gem, examining it with curiosity and openness. Whether you’re sipping your morning coffee, walking
to the mailbox, or listening to a friend, mindfulness invites you to fully inhabit that experience, bringing a sense of clarity and calm to your day.
Next, Compassion: Compassion is the heart’s response to suffering— both our own and others’. It’s recognizing the struggle in the person who cut you off in traffic and choosing empathy over anger. Compassion can be as simple as offering a kind word to someone having a tough day or as profound as forgiving yourself for a past mistake. It’s about opening your heart, allowing it to be touched by the pain, and responding with kindness.
Lastly, Impermanence: This teaches us that all things change, that nothing is permanent. It’s a reminder not to hold too tightly to possessions, experiences, or even emotions, understanding that they will pass. This doesn’t mean living in detachment but rather embracing the flow of life, celebrating the good times without clinging and accepting the challenging
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times without despair.
By weaving mindfulness, compassion, and an understanding of impermanence into the fabric of our daily lives, we can find a deeper sense of peace and fulfillment. These practices encourage us to live more thoughtfully, to connect more deeply
with others, and to navigate life’s ups and downs with a grounded sense of ease. Today, let’s choose to step into the serene sanctuary of these teachings, transforming our day, one mindful moment at a time.
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Healthy Heart
How Are Asthma and Heart Health Linked?
By Thor Christensen American Heart Association
Althoughthe heart and lungs are neighbors in your chest, people may think of them as separate entities with unrelated problems.
But a growing body of evidence suggests that asthma – one of the most common lung disorders – is a risk factor for cardiovascular disease.
Asthma is a serious chronic disease in which airways are inflamed, often in response to specific triggers. It affects about 25 million people in the U.S., including nearly 5 million children, causing millions of annual visits to doctors’ offices and emergency rooms.
“We call these major changes in the airways the three S’s: swelling, snot and squeezing,” said Dr. Tyra
Association showed that participants with persistent asthma had higher carotid plaque scores and higher levels of inflammatory biomarkers than people without asthma. A carotid artery runs along each side of the neck, and a high carotid plaque score is a strong predictor of clot-caused strokes and major cardiovascular events.
Dr. Nizar Jarjour, who co-authored the JAHA study, said many questions remain about the relationship between asthma and cardiovascular disease.
“If we’re treating asthma and improving asthma symptoms, what happens to cardiovascular health? What happens to brain health? Do they improve? Or don’t they?” said Jarjour, a pulmonologist and chief of Allergy, Pulmonary and Critical Care Medicine at the University of Wisconsin in
Bryant-Stephens, a pediatrician at Children’s Hospital of Philadelphia and medical director of its Community Asthma Prevention Program. “We try to control the swelling and the snot, which is mucus, because that’s what causes the airways to be twitchy as they respond to certain irritants or allergens.”
Madison.
Scientists do know that asthma and cardiovascular disease share a common bond: inflammation. The lungs add oxygen to blood, which the heart then pumps to the rest of the body. It’s possible, Jarjour said, that inflammation in the lungs “gets carried by the blood and spills over to the rest of the body and (impacts) brain health and cardiovascular health.”
Chronic inflammation of the airways over time can damage blood vessels and lead to hypertension, Bryant-Stephens said. In addition, this inflammation has been associated with
Several studies suggest people with asthma may face a higher risk for a variety of heart-related problems. One analysis, published in the journal CHEST in 2020, followed participants for more than 35 years and found a link between asthma and an increased risk for cardiovascular disease, after adjusting for other factors. A 2022 study in the Journal of the American Heart see Healthy Heart...page 13
The Framework
Legacy Community Health Breaks Ground on New Pasadena Southmore Clinic as Part of a $50 million Gift
from Houston Methodist
Legacy Community Health
(Legacy) commemorated its long-anticipated Legacy Pasadena Southmore Clinic on May 10, 2024 with Legacy and Houston Methodist leadership, board members, government officials and community supporters in attendance.
Located at 1951 Southmore Avenue in Pasadena, Legacy’s newest clinic will provide critical health care services designed to meet the unique needs of the Pasadena community.
Legacy Pasadena Southmore is one of two clinic locations funded by a $50 million gift from Houston Methodist.
“For more than 30 years, Houston Methodist has served some of the most vulnerable across the Greater Houston area,” said Cathy Easter, senior vice president of community development at
Houston Methodist. “We are proud of this expanded partnership with Legacy Community Health in Pasadena and know the community will benefit from the much-needed quality resources available at this new clinic.”
The Legacy Pasadena Southmore Clinic will fill a significant gap for residents in the area, offering access to affordable health care services. These include a full range of adult and pediatric primary care, obstetrical services, behavioral health, dental services, pharmacy and wraparound support services. Designed by Kirksey Architects, the new two-story clinic will be 40,000-square-foot and will be equipped with state-of-the-art technology.
“We at Legacy are extremely proud of the spirit of partnership and
collaboration that we have developed with Houston Methodist,” said Dr. Robert Hilliard, Jr., CEO of Legacy Community Health. “We thank Houston Methodist and the entire team, who share our commitment for increasing access to health care services in our communities.”
The Legacy Pasadena Southmore Clinic is expected to open in 2025. As part of its collaboration with Houston Methodist, Legacy is developing a second clinic in the North Acres Homes area of Houston. Legacy’s long-standing relationship with Houston Methodist
started in 1998. The hospital system has supported Legacy through such landmark programs as the Youth Re-entry Program, the Community Scholars Program, the Community Network of Care Program and Legacy Baytown’s Family Medicine Residency Program.
The largest Federally Qualified Health Center (FQHC) in the state of Texas, Legacy Community Health has over 57 clinic locations. Legacy currently serves more than 200,000 community members.
With a combined 40+ years of experience in the healthcare profession plus a decade as top producing Realtors, our expertise makes us the ideal partners for medical professionals relocating to or away from Houston.
Houston Methodist and Legacy Community Health leadership, L to R: Cathy Easter, Gregory Nelson, Rev. Kenneth Levingston; Dr. Marc Boom, Dr. Robert Hilliard, Jr., George Hawkins, Ryan Martin, and Chree Boydston
Memorial Hermann and Houston Community College Make It Easier for Employees to Attend Nursing School
Memorial Hermann Health System and Houston Community College (HCC) have partnered on a new pilot program that is giving Memorial Hermann employees a chance to attend nursing school full-time, work full-time, keep their benefits, and still have one to two days off each week.
“Many times, full-time employees enroll in nursing school and then life gets in the way,” said Bryan Sisk, senior vice president and chief nursing executive for Memorial Hermann Health System. “It’s nearly impossible for them to go to school four days a week, work three 12-hour days, take care of their children and have any kind of a life. The success rate of this is almost zero. We believe this program gives them the flexibility that they need.”
The 10 employees will participate in a 12-month pilot program, which
will take part within the hospital where they already know the rules, regulations, and policies. In addition, the participants will be able to test out of a basic skills course, allowing them to earn college credit. This reduces time needed in a lengthier course and gives them the opportunity to earn their certification quicker. Students receive a stipend through Memorial Hermann’s Learn Well Program to pay for tuition and so they can take part in nursing clinical rotations.
Employees who complete the program will also be given a chance to work as a nurse in a Memorial Hermann facility.
“If an employee has to drop out of nursing school for one reason or another, they cannot go back and pick up where they left off. They have to start all over again,”
Sisk said. “By removing some of the barriers for a working adult to become a licensed nurse, they will have a better chance to succeed. This program not only addresses workforce challenges, but it can also be life-changing for the participants and their families.”
Sisk believes this program is a creative and innovative way to generate people in the health care pipeline and put a dent in the massive nursing shortage projected to reach more than 50,000 by 2032. Partnering with HCC and other institutions on nursing programs supports a pathway for employees to bolster their professional growth and advance their careers while providing them with opportunities that
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otherwise might not be possible.
“It really does take a village, and the support our employees taking part in this program have received from the nurses they work with on the unit has been nothing short of amazing. Many have said they will do whatever they can to make sure their colleagues succeed,” Sisk said. “This is an amazing opportunity for our valued staff to help us realize our vision to create healthier communities, now and for generations to come.”
Houston Methodist Clear Lake Hospital Celebrates 10-Year Anniversary
Houston Methodist Clear Lake Hospital is celebrating 10 years as part of the Houston Methodist hospital system. Since 2014, the hospital has provided the Houston Methodist standard of care to its patients and expanded to meet the growing needs of Clear Lake and surrounding communities.
Left to right: Levi Benton, board chair; Chris Siebenaler, EVP, Network Hospitals; Jerry Neff, board trustee; Dr. Vince Nguyen, medical staff president; Carl Little, hospital CEO; Dr. Marc Boom, system president and CEO; board trustees The Honorable Holly Williamson; Elaine Renola; John Kennedy.
Last week, the hospital
commemorated the anniversary with board members, hospital and system leaders, physicians, employees and volunteers – reflecting on a decadelong journey with Houston Methodist and its contributions to the system and community.
In the last 10 years, Houston Methodist Clear Lake Hospital has hit several significant milestones focused on meeting the community’s expanding health care needs and improving access to care. New construction includes a medical office building to house Houston Methodist Orthopedics & Sports Medicine at Clear Lake
and physical therapy facilities, plus office and clinic space. The hospital also has recruited more than 40 new physicians from a broad range of specialties and opened emergency care centers in Deer Park and League City, as well as clinics in League City, Pasadena and Friendswood.
“Our journey over the last
decade has been extraordinary,” said Carl Little, chief executive officer of Houston Methodist Clear Lake Hospital. “But the true measure of our success lies with the exceptional nurses, employees, physicians and volunteers, who put our patients at the center of everything they do.”
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From Conroe to Downtown, Healthpeak is in every healthcare hub around the city.
Left to right: Levi Benton, board chair; Chris Siebenaler, EVP, Network Hospitals; Jerry Neff, board trustee; Dr. Vince Nguyen, medical staff president; Carl Little, hospital CEO; Dr. Marc Boom, system president and CEO; board trustees The Honorable Holly Williamson; Elaine Renola; John Kennedy.
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Biking Revealed to Be Associated with Less Knee Pain, SOA and ROA Later In Life
By Baylor College Of Medicine
Anewstudy published in Medicine & Science in Sports & Exercise reveals that people who participated in regular bicycling over their lifetime had a lower prevalence of frequent knee pain, radiographic osteoarthritis (ROA) and symptomatic radiographic osteoarthritis (SOA).
Rheumatologists often encourage regular physical activity for the prevention of osteoarthritis, the most common form of arthritis. However, some exercises are more effective than others. In this study, researchers were interested in studying the relationship between a
The study revealed that people who biked at any point in their lives reported less knee pain, ROA and SOA than those who never biked. Moreover, those who did bike and did so across age periods throughout their lives reported even fewer instances of all three.
“Compared to non-bicyclers, bicyclers were 17% less likely to have frequent knee pain, 9% percent less likely to have ROA, and 21% less likely to have SOA compared to non-bicyclers,” said Lo. “Additionally, each increase in the number of age periods engaged in bicycling resulted in lower likelihood of reporting knee pain, ROA and SOA.”
The main limitation to the
history of bicycling and symptomatic and structural outcomes of knee osteoarthritis.
Dr. Grace Lo, associate professor of medicine – allergy, immunology and rheumatology at Baylor and first author of the paper, conducted a retrospective, cross-sectional study using participants in the Osteoarthritis Initiative, a multicenter observational study of knee osteoarthritis of people ages 45 to 79. A self-administered questionnaire asked about leisure physical activity over a lifetime, including bicycling activities (outdoor or individual stationary cycling) or spinning over four age periods of their lives: ages 12–18; 19–34; 35–49; and age 50 and older. For each period, they indicated the number of years, months per year, and times per month they engaged in their top three bicycling activities. More than 2,600 participants completed a questionnaire with over half of the participants recording a consistent history of biking.
study was that the information regarding bicycling was retrospectively ascertained. However, the respondents were not aware of the hypothesis when recording their biking history, reducing the probability of recall bias.
Data gathered from the Osteoarthritis Initiative also has been used to evaluate running and swimming as forms of activity that may lead to less knee pain, SOA and ROA.
“The natural history of osteoarthritis is very long, making it difficult to track the different exercises you’ll do throughout your life as well as their impact on joint health,” Lo said. “The big takeaway from this observational study is that if people are concerned about knee pain, ROA and SOA later in life, biking may serve as a way to prevent this and that the more often they do it throughout their lives, the higher the probability of better knee health.”
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Financial Forecast Working in Retirement
Should You Continue to Generate an Income After You’ve Retired?
WhileBy Grace S. Yung, CFP Midtown Financial Group, LLC
many people strive to say goodbye to employment world upon retirement, it could make sense to continue working after you retire. Today’s world is far different from just a generation ago – starting with the fact that people are living longer. And a longer life means that you’ll need money to keep flowing in so you can
Not knowing how to best generate income and/or draw down assets
Outliving savings
Given this, there are many reasons to work in retirement, such as for:
Generating extra cash
Keeping pace with inflation
Maintaining health insurance
Increasing savings
Maximizing Social Security benefits
Staying active socially
Generating Extra Cash
Typically, when you are working, you aren’t spending money
pay for the goods and services you need.
Longevity is often considered one of the biggest threats to your financial security in retirement, because a longer life exposes you to other monetary-related risks for a longer period of time. So, having a plan in place to continue generating income is critical.
Why Consider Working During Retirement
According to the Schroders 2024 U.S. Retirement Survey, the top concerns facing retired Americans include:
Inflation lessening the value of assets
Higher than expected healthcare costs
A stock market downturn
unnecessarily. In retirement, every day is “Saturday.” This could involve more trips to the store and spending on non-essential items. In some cases, shopping could provide a way to fight boredom.
Keeping Pace with Inflation
With longer life expectancy, it’s possible that some people could live for 20+ years in retirement. Over time, prices of goods and services usually go up. So, even if you currently generate a comfortable amount of income, you will likely need more in the future just to keep your lifestyle on pace.
Maintaining Health Insurance
If you retire before you are eligible for Medicare, working could
Healthy Heart
Continued from page 6
plaque buildup in the arteries, which can result in a heart attack or stroke, she said.
Many people with asthma find relief from medicine delivered through an inhaler or in tablet form. Those with persistent asthma typically use daily medications to control the symptoms and prevent asthma attacks. But, some have questioned whether the medications can influence asthma’s negative impact on cardiovascular health.
“That’s the million-dollar question,” Jarjour said. “The problem is that you cannot ethically conduct studies where patients have persistent asthma and who are not being treated with proper medications.”
Like many health problems, including cardiovascular disease, asthma does not affect everyone equally. A 2020 report from the Asthma and Allergy Foundation of America said multiple studies show the burden of asthma falls disproportionately on Black, Hispanic, American Indian and
Alaska Native people.
“It’s a significant health disparity that really needs to be addressed,” Jarjour said. “And it’s hard to disentangle the various aspects of these disparities because multiple (risk factors) come with socioeconomic disadvantages, like poverty, poor nutrition, stress or living close to a highway or having a job that exposes you to pollution.”
Medical professionals who treat asthma patients advise them to avoid external triggers, which include pollens, molds, dust, mice and cockroaches, as well as air pollution sources, such as smog, ozone and smoke from charcoal grills, wood fires and cigarettes.
Weather can also worsen asthma, especially if you exert yourself outdoors when it’s too hot or too cold, or the air is especially humid or dry, Jarjour said.
“Our bodies are used to conditioning the air we breathe to the normal body temperature of 98.6 degrees and a proper humidity level,” he said. “If you move away from this too much in one direction or another, you
Financial Forecast
Continued from page 12
provide you with employee benefits like health insurance. If you work for a company that does not offer these benefits, the extra money that you earn working could go towards paying the premium for an individual policy.
Increasing Savings
There are many ways that working in retirement can help you increase your savings. For instance, the company you work for could offer a retirement plan. If so, participating allows you to generate tax-advantaged earnings. Many companies also “match” a percentage of their employees’ retirement plan contributions. This is “free money.”
Maximizing Social Security Benefits
If you work during retirement, you may also be able to delay taking Social Security. There are several advantages to this. For instance, while Social Security can be claimed as early as age 62, the dollar amount of the benefit is less than it would be
if you waited until your full retirement age.
Conversely, delaying receipt of Social Security can increase the dollar amount of your benefit. For every year you wait to file beyond your full retirement age (until age 70), you essentially get a “raise” of 8%.
Staying Active Socially
Working during retirement can also provide you with a way to spend your time productively and socially. Plus, studies show that doing so can help to keep your mind sharp.
Should You Work During Retirement?
While working in retirement can provide financial benefits, it may not be right for everyone. To determine what is best for you and your specific needs, it is best to discuss your situation with a CERTIFIED FINANCIAL PLANNER™ professional who can walk you through various scenarios and guide you in the right direction.
put added stress on the bronchial tubes, which can stimulate constriction.”
Climate change could make asthma and cardiovascular disease worse. A 2023 study in the AHA journal Circulation said cardiovascular deaths from extreme heat in the U.S. could double by 2050. While few studies have looked at global warming’s potential impact on asthma, Bryant-Stephens said an increase in hot, humid days will definitely impact breathing and lengthen the pollen season, “so we will see an increase in the number of acute respiratory events.”
Even though there’s no cure for asthma, it can be controlled. “It’s exciting to see how much better we are at controlling symptoms than we were 30 years ago,” she said.
However, it’s impossible to control asthma if you don’t know you have it, Bryant-Stephens said.
“I hear parents and grandparents all the time say, ‘Oh, I don’t have asthma. I have bronchitis.’ And when I ask them about their symptoms over
the course of their life, it is asthma,” she said. “If you’re suffering from recurrent coughing, especially if it seems triggered by weather changes, my advice is to ask your doctor to actually test you for asthma.”
Bryant-Stephens also said it’s essential for adults to control their asthma even if they’re dealing with other major health problems.
“When people are focusing on heart disease, asthma kind of gets dropped by the wayside,” she said. “But it’s important to make sure your asthma is fine-tuned and managed as closely as possible, because that will put less stress on your heart from a breathing perspective.”
Rules
Continued from page 1 requirements may be too high given the limited market of LDTs for unmet needs. Further, FDA believes there are appropriate safeguards in place within a hospital system as well as shared responsibility and liabilities for patient outcomes to allow for this enforcement discretion. Therefore, FDA emphasizes that this limited exception would not extend to patients treated at an affiliated hospital with a different corporate ownership than the laboratory. The policy is also restricted to LDTs ordered by a healthcare practitioner on staff or with credentials and
Oncology
Continued from page 3
vegetables, whole grains, and lean proteins, and limit the intake of processed foods, sugary snacks, and red meats, which have been linked to increased cancer risk. Additionally, strive to maintain a healthy weight through regular exercise and portion control, as obesity can be a factor in cancer development.
3) Stop Smoking
Smoking remains one of the leading causes of cancer, increasing risk of lung, throat and mouth, esophagus, stomach, kidney and bladder, pancreas, liver, and colon and rectal cancers, as well as acute myeloid leukemia. In
privileges at a facility owned and operated by the same healthcare system employing the laboratory director and performing the LDT.
Currently marketed IVDs offered as LDTs that were first marketed before the issuance of the Final Rule. In a significant win LDTs already on the market, FDA will not require these tests to undergo premarket review. This policy only applies provided the LDTs are not modified or are modified in limited ways.
Non-molecular antisera LDTs for rare RBC antigens when such tests are manufactured and performed by blood establishments, including transfusion services and
immunotherapy laboratories, and when no alternative IVD is available to meet the patient’s need for a compatible blood transfusion.
Next Steps
IVD manufacturers should continue to monitor the situation closely as it evolves. Regardless of how this process plays out in the courts, stakeholders should presume change is on the horizon. Stakeholders should read the Rule carefully to understand what they need to do to become compliant. For entities manufacturing several LDTs, this may include taking an inventory of all tests currently being marketed and understanding which buckets of regulatory compliance will be relevant for each test.
Continued from page 4
patient care and accessibility.
EnMed student teams captivated the audience with rapid-fire presentations, showcasing the forefront of healthcare innovation and affirming TMC’s dedication to fostering emerging talent. Among the standout projects were those of Basil Alias, M3, who unveiled “A Novel Approach to Thromboembolic Event Detection,” a groundbreaking endeavor poised to transform cardiovascular health.
Meanwhile, Duncan Salmon, M2, delved into the intricate realm of neuro-navigation with his project, “Developing Clinical Software to Map Resting-State fMRI (rs-MRI)
2024, an estimated 116,310 new cases of lung cancer in men in the U.S. are predicted, with 65,790 deaths. If you smoke, take immediate steps to quit. Seek support from cessation programs, nicotine replacement therapies, or counseling services.
4) Limit Alcohol Consumption
The more alcohol you consume, the higher your risk of cancer. Excessive drinking can elevate the risk of certain cancers, including liver, colorectal, esophagus, and head and neck. Some studies have shown that drinking three or more alcoholic drinks per day can increase the risk of stomach and pancreatic cancers. The 2020-2025 Dietary Guidelines for Americans recommends moderate alcohol intake, limiting men to no more than two
Networks,” offering promising advancements in brain imaging that could revolutionize surgical planning.
In a bold departure from convention, Koby Reid, M3, presented “Clean Cuts with Dirty Tools: Re-using Medical Instruments in the Wild,” challenging established norms and reshaping perceptions on sustainability in medical practices. These visionary projects not only stirred excitement but also hinted at the transformative potential driving the future of healthcare.
The rapid-fire presentations from EnMed student teams, exemplify the vanguard of healthcare innovation and underscores EnMed’s Inaugural Dean, Dr. Roderic Pettigrew’s leadership and vision and TMC’s commitment to nurturing emerging talent.
drinks per day.
5) Stay Active
According to the American Society of Clinical Oncology (ASCO), a growing body of research suggests that regular exercise can help lower cancer risk. Aim for at least 150 minutes of moderate exercise or 75 minutes of vigorous activity each week, incorporating a mix of aerobic, flexibility, and strength training exercises for optimal health benefits. By adopting these proactive measures, men can take control of their health and reduce their risk of cancer. Prioritizing preventive care and making health-conscious choices are powerful actions to reduce a man’s risk of cancer.
Dr. Rory Cooper, laureate of the National Medal of Technology and White House honoree, culminated the symposium by articulating the intricate amalgamation of art and science in healthcare innovation, stressing its pivotal role in addressing global health challenges.
The symposium served not only as a crucible for ideation but also as a nexus for forging alliances that transcend the boundaries of the Texas Medical Center. As attendees departed, they embraced a shared vision, fortified by wisdom and collaboration, and fueled by the inspiring efforts to revolutionize healthcare, thereby enhancing countless lives worldwide.
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