On September 2, 2020, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a new “Health Apps” feature on the HHS.gov website.  The new website, which replaces the OCR’s Health App Developer Portal, highlights existing guidance for mobile health (“mHealth”) apps regarding the Health Insurance Portability and Accountability Act

On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software.

The concept of “multiple function” products was introduced by the 21st Century Cures Act (“Cures Act”) of 2016, which

Software development can teach us a lot about streamlining the research and development (R&D) process in other industries.  “Agile development”, or the process of dividing up an R&D project into smaller, more iterative segments instead of planning the entire project at its inception, is a hallmark of the software development process.  In a recently published

On May 8, 2020, the Federal Trade Commission (“FTC”) issued a notice soliciting public comment regarding whether changes should be made to its Health Breach Notification Rule (the “Rule”).  The request for comment is part of a periodic review process “to ensure that [FTC rules] are keeping pace with changes in the economy, technology, and

Lee TiedrichB.J. Altvater, and James Yoon recently published an article summarizing recent developments in artificial intelligence law and policy on the University of Pennsylvania Law School’s Regulatory Review.  The article primarily focuses on developments in the United States, including the National Artificial Intelligence Initiative Act introduced by members of the House Committee

On April 14, 2020, FDA issued a direct-to-final guidance outlining its “Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”  The guidance intends to “expand the availability of digital health therapeutic devices” – possibly the first time FDA has used such term in its written policies – to facilitate consumer and patient use and reduce potential exposure to COVID-19.  The guidance applies to two groups of products: (1) computerized behavioral therapy devices and other digital health devices for psychiatric disorders; and (2) low-risk wellness and digital health products for mental health or psychiatric conditions. Like FDA’s many other COVID-19 enforcement policies, the policy will remain in effect “only for the duration of the public health emergency related to COVID-19.”
Continue Reading FDA Issues COVID-19 Policy for Certain Digital Health Solutions

The rapid spread of COVID-19 has transitioned the telehealth debate from a matter of access, convenience, and cost-saving to a matter of absolute necessity on a large scale. A variety of barriers have traditionally stood in the way of broader adoption of telehealth including a lack of reimbursement by both state and private insurance, restrictions

On April 8, 2020, the Federal Trade Commission (“FTC”) released a blog post about the use of artificial intelligence (“AI”) and algorithms in automated decisionmaking. The blog highlighted the potentially great benefits and risks presented by increasingly sophisticated technologies, particularly in the “Health AI” space. However, it also emphasized that automated decisionmaking is not a

The COVID-19 crisis is demonstrating the potential of digital health technology to manage some of our greatest public health challenges.  The White House Office of Science and Technology Policy has issued a call to action for technology companies to help the science community answer high-priority scientific questions related to COVID-19.  The Centers for Disease Control

Product liability considerations are not likely the first concerns that spring to mind for the many companies working to develop digital health countermeasures and other products related to COVID-19.  Yet even while putting together solutions on an accelerated timeline, there are some straightforward actions that companies can take that may reduce litigation risk down the