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As more and more states are enacting privacy laws, organizations in the health care industry may be wondering what the impact these laws will have on them. At this point, there are privacy laws in 12 states, with one more (Delaware) likely to be signed by the governor soon. Those laws are in California, Colorado, Connecticut, Florida, Indiana, Iowa, Montana, Oregon, Tennessee, Texas, Utah, and Virginia. (There is also a new law in Delaware currently pending the governor’s signature). Not all are in effect. Only the laws in California, Connecticut, Colorado and Virginia are effective. The others will go into effect between December of this year and 2026, as follows:…

Continue Reading State Privacy Law Roundup: What Health Care Companies Need to Know

On April 27, 2023, the state of Washington enacted a landmark privacy law aimed at protecting the privacy of health data not covered by HIPAA. This law, named the “My Health My Data Act,” covers a very wide range of entities, consumers, and data. It also contains a private right of action. Companies should soon begin evaluating the scope of this law and its requirements before it comes into effect March 31, 2024 (for “small businesses,” June 30, 2024).…

Continue Reading Washington State Enacts Landmark Privacy Law Aimed at Digital Health Industry

In light of the increasing demand for mental health treatment and simultaneous provider shortages, the private insurance industry is rolling out targeted initiatives to increase mental health support for members by mitigating many of the barriers to entry facing the mental health industry today.…

Continue Reading Payor-Led Initiatives to Strengthen Mental Health Resources

As we approach the middle of the first quarter of 2023, private equity firms have continued to demonstrate their interest in investing in digital health. This does not come as a surprise, as most startups in the healthcare technology space have been active in developing attractive strategies. These companies strive to improve health outcomes and lower expenses by focusing on specific gaps, issues or illnesses, prioritizing technological innovation, and customizing individualized care plans.…

Continue Reading Private Equity and Digital Health in 2023: Policy Updates and Trends to Watch

This blog is the second installment of our Digital Health Trends series.

Overview

Digital health services have exploded since the onset of the COVID-19 pandemic, and behavioral health services have seen large increases in utilization. Prior to the pandemic, telehealth visits for mental health or substance use disorder represented less than 1% of outpatient visits, but by mid-2020 nearly 40% of telehealth outpatient visits were for mental health or substance use.[i] Behavioral health is the highest-funded clinical indication within digital health, and digital behavioral health companies raised $1.7 billion in the first three quarters of 2022.[ii] Investments in behavioral digital health services have the potential to transform the healthcare system in several key areas.…

Continue Reading The Transformation in Behavioral Digital Health Services

Most companies operating websites and mobile apps use some form of tracking technologies on these digital properties. While these types of technologies have been used for some time and serve a variety of purposes, the use of them by organizations regulated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) has garnered more recent attention within the past year. In the wake of recent public concerns, the Office of Civil Rights (OCR) at HHS recently released guidance on the use of these tools by HIPAA-regulated entities. OCR’s guidance distinguishes between tracking on authenticated and unauthenticated websites and on mobile apps. We summarize this guidance below.…

Continue Reading OCR Releases Guidance on Use of Tracking Technologies

This blog is the first in our Digital Health Trends series.

Digital health’s explosion in the last few years has led to the proliferation of new technologies and novel solutions to long-standing health problems. FemTech, in particular, has become a major movement in women’s healthcare, and the market appears ready to support this rapid growth. A recent report projects FemTech to grow by approximately 17% over the next five years with a market value over $60 billion.[1] Despite FemTech’s initial focus on access to reproductive health services, the FemTech market has evolved to encompass a broad range of women’s health issues from fertility to cardiovascular disease while increasing access to traditionally stigmatized or ignored health conditions such as menopause, mental health, and sexual health.…

Continue Reading The FemTech Revolution

As telehealth services surged in response to the COVID-19 pandemic, unique compliance challenges likewise developed in unexpected ways. Recognizing these challenges, the Office of Civil Rights (“OCR”) indicated that it would exercise its enforcement discretion by declining to impose penalties against covered health care providers for instances of good faith noncompliance with the requirements of the Health Insurance Portability and Accountability Act (“HIPAA”) in connection with the provision of telehealth services. In effect, a covered health care provider seeking to use audio or video communication technology to provide telehealth services during the public health emergency could do so with greater flexibility.…

Continue Reading Office of Civil Rights Publishes Guidance on Use of Audio-Only Telehealth Services

The metaverse has been described as the “next frontier” and the “new era” of healthcare. Although still a loosely defined and relatively broad term, the “metaverse” generally refers to a shared virtual environment accessed by individuals via the Internet. Individuals generally enter the metaverse through the following four technologies: virtual reality, augmented reality, mixed reality and extended reality.  …

Continue Reading Digital Health in the Metaverse: Three Legal Considerations

The digital health sector has seen tremendous growth and innovation over the past few years. This momentum introduces new complexities within the legal and regulatory landscape that is trying to…
Continue Reading Top 5 Legal Issues in Digital Health to Watch for in 2022

On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) announced that it will be taking actions to advance its strategic commitment to drive innovation to support health equity and high quality, person centered care. CMS’ 2022 Physician Fee Schedule final rule (the “Final Rule”), will focus on, amongst other things:
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Continue Reading Health Equity Remains a Priority for the Center for Medicare and Medicaid Services in 2022