Dear John,

Join us on December 5 for our issue briefing focusing on Global Lessons From COVID-19 at which authors from around the world will present their work, engage in discussions, and answer questions on these important issues.

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Evaluating Clinical Studies Of Prescription Digital Therapeutics

Digital therapeutics rely on software as the primary mechanism for diagnosis or intervention, and prescription digital therapeutics are a growing subset of digital therapeutics regulated by the Food and Drug Administration (FDA).

In the November issue of Health Affairs, Anika Kumar of the University of California San Francisco and coauthors analyze clinical studies of twenty prescription digital therapeutics authorized by the FDA and available on the market as of November 2022. 

Kumar and coauthors identify a series of limitations in the rigor of evidence associated with these therapeutics, finding that “just 10 percent of these technologies were evaluated in at least one study that met all of the criteria for the highest strength of evidence,” and two-thirds of clinical studies examined were conducted on a postmarket basis with less rigorous standards of evidence than those standards used in premarket studies.

The researchers highlight the need for a more rigorous and inclusive approach to clinical research for prescription digital therapeutics. 

Arriving At A Fair Price In The Medicare Drug Price Negotiation Program: Considerations From Other Countries

John K. Lin et al.

With today's featured article focusing on pharmaceuticals and medical technology, get the full story by exploring our extensive archive of podcasts on these topics.

Take a look below at a few highlighted episodes:

• A Health Podyssey: James Robinson on Life Sciences Innovation Acceleration (August 2023)
• Health Affairs This Week: The Long and Winding Road of Regulating Laboratory Developed Tests (August 2023)
• A Health Podyssey: Amelia Bond on 340B's Influence on Biosimilars (May 2023)

For the month of November, we are recognizing National Family Caregivers Month.

Throughout this month, we will be highlighting papers from over the years that illuminate this role through a health policy lens.

In the 2019 Community Care For High-Need Patients theme issue, Katherine Ornstein and coauthors consider the effects of caregiving in the last years of life on surviving spouses and how this can result in increased depression as well as negative health outcomes.