The following guidance could be relevant to manufacturers of software as a medical device (SaMD). The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent discontinuance … Continue Reading
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
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 … Continue Reading
Digital health companies are playing an important role in the global response to the COVID-19 public health emergency. For example, the White House Office of Science and Technology Policy issued a Call to Action to the tech community requesting help in answering urgent scientific questions about COVID-19. As readers of this blog are aware, some … Continue Reading
This is the 11th, and final, of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: Why involve a lawyer?… Continue Reading
This is the tenth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: What are the priorities for the solution?… Continue Reading
This is the ninth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: Who will own the intellectual property rights?… Continue Reading
This is the eighth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: what is novel in the digital health solution and what will give the solution a competitive advantage?… Continue Reading
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
This is the sixth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: what are the limits on how the data can be used and disclosed?… Continue Reading
This is the fifth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: who will pay for the offering?… Continue Reading
This is the fourth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: what data will be needed to substantiate the offering?… Continue Reading
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
This is the third of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: who will provide the data used in the offering?… Continue Reading
This is the second of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: who will provide the various components of the offering?… Continue Reading
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
On April 2, 2019, FDA released a discussion paper entitled “Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)” (the “AI Framework”). The AI Framework is the Agency’s first policy document describing a potential regulatory approach for medical devices that use artificial intelligence (“AI”) and machine learning (“ML”). The … Continue Reading
On January 3, 2019, the National Medical Products Administration (“NMPA”) published a draft standalone software appendix of medical device good manufacturing practice (“Draft Standalone Software GMP” or “Draft Appendix”) for public comment (available here). Comments are due on January 30, 2019. China revised its medical device GMP in 2014, which apply to all classes of … Continue Reading
As previewed by Commissioner Gottlieb several months ago (see our earlier post here), FDA published a notice in the Federal Register on November 20, 2018, to propose a new framework for “prescription drug-use-related software.” The Agency defines this digital health category widely as software disseminated by a prescription drug sponsor for use with the sponsor’s … Continue Reading
In light of the rapidly expanding field of medical software technology, and its recognition that traditional approval mechanisms for hardware-based medical devices may not be well suited to regulating such technology, FDA is piloting a new, streamlined regulatory approach for digital health technologies. The initiative, currently a “working model” and known as the Software Precertification … Continue Reading
On April 26, Commissioner Gottlieb addressed the agency’s progress on FDA’s Digital Health Innovation Action Plan and announced several additional steps the agency is taking to advance the potential benefits of digital health. Here is a recap of the key updates: (1) Launch of New FDA Program to Apply Digital Health to Drugs As our … Continue Reading
Inflection Point for IoT In a relatively short amount of time, the adoption of the Internet of Things (IoT) and its applications— from smart cars to the myriad of interconnected sensors in the General Service Administration building reminiscent of HAL 9000 from 2001: A Space Odyssey— has rapidly proliferated, providing significant opportunities and benefits. However, … Continue Reading
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
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
