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

To assist companies that are developing technology solutions to help predict, mitigate or contain the spread of COVID-19, our cross-practice digital health team has put together a checklist of considerations to keep in mind (available here).

For additional guidance, please visit our COVID-19 Legal and Business Toolkit (available here).

In this final instalment of our series of blogs on the European Commission’s plans for AI and data, announced on 19 February 2020, we discuss some potential effects on companies in the digital health sector. As discussed in our previous blog posts (here, here and here), the papers published by the European Commission cover broad concepts and apply generally — but, in places, they specifically mention healthcare and medical devices.

The Commission recognizes the important role that AI and big data analysis can play in improving healthcare, but also notes the specific risks that could arise given the effects that such new technologies may have on individuals’ health, safety, and fundamental rights. The Commission also notes that existing EU legislation already affords a high level of protection for individuals, including through medical devices laws and data protection laws. The Commission’s proposals therefore focus on addressing the gap between these existing rules and the residual risks that remain in respect of new technologies. Note that the Commission’s proposals in the White Paper on AI are open for public consultation until 19 May 2020.


Continue Reading European Commission’s Plans for AI and Data: Focus on Digital Health (Part 4 of 4)