Tag Archives: FDA

FDA Issues Final Guidance on Multiple Function Digital Health Software and Other Devices

By Amy Leiser, Christina Kuhn, Kathryn Culver, Scott Danzis and Wade Ackerman on Posted in Digital Health, Medical Devices and FDA, Software
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 added … Continue Reading

FDA Issues COVID-19 Policy for Certain Digital Health Solutions

By Elizabeth Guo and Wade Ackerman on Posted in COVID-19, Digital Health, Medical Devices and FDA, Uncategorized
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 … Continue Reading

Ideation Question #7: Are Healthcare Providers Involved, and What Questions Should Be Considered for Collaborations?

By Sarah Franklin on Posted in Data Security, Digital Health, Health Data, Medical Apps, Medical Devices and FDA
This is the seventh of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process.  Today’s video explores the question: are healthcare providers involved, and what questions should be considered for collaborations?… Continue Reading

FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

By Elizabeth Guo, Christina Kuhn, Wade Ackerman and Scott Danzis on Posted in Artificial Intelligence (AI), Digital Health, Medical Apps, Medical Devices and FDA, Software
On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ensure … Continue Reading

Top 10 Questions During Ideation of Digital Health Solutions

By Christina Kuhn, Wade Ackerman and Sarah Cowlishaw on Posted in Data Security, Health Data, Medical Apps, Medical Devices and FDA
Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions.  “Ideation” is the part of that process and involves the rapid identification and creation of ideas for digital health solutions, which are then prototyped and tested.  Covington has created a Top 10 Questions for Ideation of Digital Health … Continue Reading

FDA Announces Public Workshop on Using Randomized Clinical Trials to Generate Real-World Evidence

By Mingham Ji, Wade Ackerman and Krista Carver on Posted in EHR/EMR, Health Data
Today, FDA published a notice in the Federal Register announcing a public workshop on July 11-12 entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.”  This workshop builds on FDA’s ongoing efforts to implement the Real-World Evidence (RWE) Framework published in December 2018, which we previously discussed in this post. According to … Continue Reading

Key Takeaways from FDA’s Framework for Real-World Evidence for Pharmaceuticals

By Mingham Ji, Wade Ackerman, Krista Carver, Nigel Howard and Denise Esposito on Posted in Artificial Intelligence (AI), Health Data, Innovation, Medical Apps
On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”).  In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top … Continue Reading

What physicians are reading about digital health

By Nigel Howard, David Wildman and Wade Ackerman on Posted in Regulatory Incentives
There are two papers in the May 15 volume of the Annals of Internal Medicine that discuss digital health applications and are illustrative of the topics being considered by physicians as they evaluate the adoption and impact of digital solutions.  These papers serve as examples of the active dialogue taking place around the appropriate regulatory … Continue Reading

Key Takeaways from Covington’s Webinar about Digital Health Associated with Pharmaceuticals

By Grant Castle, Sarah Cowlishaw, Wade Ackerman, Christina Kuhn and Covington Digital Health Team on Posted in Emerging Companies, Medical Apps, Medical Devices and FDA
On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals.  Here are some key takeaways from that webinar: Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage, whether you’re a pharma company … Continue Reading

FDA Outlines Updated Approach to Regulating Digital Health Technologies

By Christina Kuhn, Wade Ackerman, Scott Danzis and Covington Digital Health Team on Posted in Artificial Intelligence (AI), Medical Apps, Medical Devices and FDA
On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft guidances announce the … Continue Reading

The Evolving FDA and EU Equivalent Regulation of Digital Health: A Device Perspective

By Grant Castle, Sarah Cowlishaw, Scott Danzis and Christina Kuhn on Posted in Medical Devices and FDA
On November 14, lawyers from Teva Pharmaceuticals and Covington & Burling discussed digital health innovation from a medical device regulation perspective in the U.S. and the EU. The presentation by Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals, and Grant Castle, Scott Danzis, Sarah Cowlishaw, and Christina Kuhn of Covington, covered topics such as … Continue Reading

FDA Initiates Software Precertification Pilot Program

By Christina Kuhn on Posted in Medical Apps, Medical Devices and FDA
On Friday, July 28, FDA announced a new Software Pre-certification (Pre-Cert) Pilot Program in a Federal Register notice.  The Pre-Cert program is one of three main action items discussed in the agency’s recently-released Digital Health Innovation Action Plan.  CDRH also held a webinar on August 1 to provide an overview of the program and answer … Continue Reading

FTC Releases Online Tool to Help Health App Developers Identify Applicable Laws

By Christina Kuhn on Posted in FTC, Health Data, HIPAA and Data Privacy, Medical Apps
On April 5, the Federal Trade Commission (FTC), in conjunction with the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), released a new web-based interactive tool to assist mobile health app developers in navigating applicable federal laws and regulations in the areas of advertising and marketing, medical devices, and … Continue Reading
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