Year: 2024

The demographic landscape in the United States is undergoing an unprecedented shift as the older population continues to increase. In the next decade, the number of people aged 65 or older is projected to outnumber those under 18. Older adults face unique social, physical, and economic challenges. As this population grows, our nation will need to find comprehensive alternatives to the current systems, which are already struggling to adequately support the complex needs of persons 65 and older.

As we age, daily tasks and activities become more difficult. While moving into an assisted living facility or nursing home may seem like the obvious next step for aging adults who need additional care and support, for many, this move may be unnecessary, unattainable, or unwanted.

Studies show that approximately 95 percent of older adults want to continue residing in their own homes and communities. This concept, known as aging in place, allows the nation’s growing population of older adults to live independently and “age with dignity.” This desire is driven by numerous factors, including high facility costs, the uncertainty of transitioning to a new and unfamiliar environment, the desire for independence, and the absence of their support systems.

However, there are challenges and risks associated with living independently in one’s own home, such as increased difficulty performing daily tasks, lack of transportation, a risky home setup, potential for isolation, and the need for additional care. Additionally, as the nation’s aging population grows, so will the fraction of vulnerable older adults who will require more assistance than those who are in good health, have strong social connections, and possess adequate resources.

Nevertheless, individuals can safely remain in their homes and communities with support. Given the increase of older adults who will inevitably age in place, and face challenges that can make independent living more difficult, the need for additional services and support is imperative.

On February 6, 2024 the Administration for Community Living (ACL) announced its final rule to update regulations for implementing its Older Americans Act (OAA) programs. This update reflects the increased needs of a nearly doubled senior population since the last substantial update to the OAA regulations in 1988.

First passed in 1965, the OAA authorized programs and services to help older adults remain in their homes and communities. Since the last substantial update to OAA regulations 36 years ago, there is a deeper understanding of how social determinants of health can be used to reshape healthcare, and health care service delivery models, through the use of non-medical services. OAA programs provide older adults with resources to remain in their communities and places of residence, empowering them to age in place and avoid institutionalization or hospitalization. The OAA offers a range of services and support, such as home-delivered meals, congregate meals, caregiver assistance, personal and home care services, preventive health services, and transportation. These services play a crucial role in enabling older adults to maintain their independence and place in their communities, ensuring that aging in place becomes a viable and sustainable option for individuals across the country.

Between 2019 and 2021, the market for mental health and wellness apps such as Calm, Headspace, and BetterHelp increased by 54.6%. In 2020 alone, the top 100 wellness apps were installed over 1.2 billion times. This increase can be attributed to the Covid-19 pandemic. Lockdowns and the rise of remote work led to an increased number of people turning to mobile apps to work on their health and fitness goals from home. Studies have also shown that individuals with existing mental health problems reported that their symptoms worsened during the pandemic. In this case, the convenience of mental health apps has enabled users to connect with therapists and mental health coaches from the comfort of their home. Today, an increasing number of physicians recommend their patients to use mental health apps to reduce stress and improve sleep habits, with apps such as Calm allowing patients to access content through their health insurance plan. 

But as mental health apps continue to grow in popularity, researchers have begun raising privacy concerns surrounding the collection of user data. For instance, the Federal Trade Commission (FTC) issued a proposed order in 2023 banning BetterHelp, an online counseling service, from sharing sensitive information about mental health challenges for advertising. This included requiring the app to pay a $7.8 million settlement to consumers. In this case, it is useful to consider what the current privacy concerns are as well as policy solutions to address the issue. One of the main issues concerns the volume of data that is collected by mental health apps. For instance, data collection can include geolocation information such as clinic visits and purchase history for healthcare services. Furthermore, mental health apps may collect other sensitive information such as a user’s full name, date of birth, or home address, as well as health biometrics on a user’s mood, sleep habits, or symptoms. In the case of BetterHelp, the app’s privacy policy now states that they are not paid for user data, but that they may share visitor data with third party advertisers such as Meta, TikTok, Snap, and Reddit. 

This leads to the question of what improvements can be made to protect sensitive data of users on mental health apps and what solutions are available to developers and policymakers. Currently, HIPAA regulations do not apply to most mental health apps unless it involves a covered entity, a business associate relationship, and the disclosure of electronic protected health information (ePHI). However, there are various steps that can be taken to safeguard user data. One study created a list of actions that stakeholders could take to ensure data privacy. This includes a variety of recommendations, including the creation of a privacy impact assessment and having readable privacy policies with accessible language. De-identification is another option that developers can take to protect user data, which can involve removing specific identifiers such as names and addresses. In addition, apps that do not fall under HIPAA regulations are now required to follow the FTC’s Health Breach Notification Rule, released in June 2023, which requires apps providing health care services or supplies to to notify consumers, the FTC, and often the media of data breaches. Overall, both new and current developers behind mental health apps can take these steps to better protect sensitive data and to build trust among users in the digital space. 

In the rapidly evolving world of reproductive technologies, in vitro fertilization (IVF) stands out as a beacon of hope for countless individuals striving to conceive. As this technology advances, it is increasingly confronted with complex ethical, legal, and medical challenges. These challenges highlight the ongoing struggle to maintain a balance between facilitating medical innovation and ensuring rigorous regulatory practices while also prioritizing comprehensive patient care.

A recent incident involving CooperSurgical, a major supplier in the fertility industry, brings to light this balance between innovation and regulation in the fertility industry. The company is facing several lawsuits from patients who claim that one of its products—a nutrient-rich liquid that helps fertilized eggs develop into embryos—was defective, destroying the embryos for potentially thousands of patients worldwide. This incident not only underscores the vulnerabilities inherent in assisted reproductive technology (ART) industries but also the critical importance of ensuring that the advancements in ART are matched with effective legal frameworks and ethical standards. Addressing these challenges is essential to safeguarding patient interests, and ensuring the pursuit of fertility treatment is safe and effective.

This week, the Food and Drug Administration (FDA) issued a notice stating that CooperSurgical recalled three lots of the liquid used for embryo transfer in multiple clinics during November and December. While CooperSurgical notified the affected clinics on December 13^th, it is unclear how many bottles of the botched media they used before the recall. In lawsuits filed by impacted patients, the plaintiffs assert that the defective product purportedly lacked magnesium, a key nutrient whose absence halted the development of their embryos, rendering those embryos unviable for transfer. These lawsuits further demonstrate the challenging and emotional journey of IVF for individuals seeking fertility treatment that is further complicated by corporate negligence and product recall. In the most recent of eight lawsuits filed, a couple received a phone call on Thanksgiving notifying them that all the embryos had stopped growing. Unaware of the product recall, the plaintiff attributed this failure to herself, blaming her age, before being notified two months later that the clinic used the defective CooperSurgical media on her embryos.

Infertility affects approximately 1 in 8 couples in the United States, many of whom turn to IVF as a solution. Fertility medicine and ART are relatively new fields with the first live birth from IVF occurring in 1978. However, since this breakthrough, IVF has rapidly become a common remedy for those seeking infertility treatment and now accounts for 1.6% and 4.5% of all live births in the United States and Europe. The growing demand for IVF incentivizes companies like CooperSurgical to position themselves as leaders in a largely unregulated industry. The regulatory landscape of assisted reproduction is complex as the U.S. Department of Health and Human Services exerts only limited oversight over fertility clinics. The lack of stricter federal regulatory practices incentivizes corporations to prioritize economic considerations over ethical principles in their decision-making. CooperSurgical owns multiple large sperm and egg banks, bringing in $1.2 billion in revenue last year with 40 percent coming from fertility services and supplies. This lucrative market for fertility treatment underscores the recent trend in manufacturing issues resulting from rapid growth and consolidations in those companies that supply the industry with their products. The IVF journey, while filled with hope for individuals facing infertility, is fraught with challenges that demand attention from medical professionals, regulatory bodies, and legal authorities. The issues that arise out of the case against CooperSurgical are a stark reminder of the devastating impact that corporate oversights, a lack of stricter regulatory practices, and overall disregard for an already emotional process can have on individuals’ lives. As the field of reproductive medicine continues to evolve, it must do so with a commitment to protecting patient care and ethical standards.