Medical Devices

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 Ideation Question #6: What Are the Limits on How the Data Can Be Used and Disclosed?

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 Ideation Question #4: What Data Will Be Needed to Substantiate the Offering?

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 alignment with the new approaches being adopted by the Agency.

As background, FDA issued draft guidance documents in December 2017 that sought to implement section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), which was enacted by Congress in the 21st Century Cures Act of 2016 (the “Cures Act”). Those guidance documents raised a number of issues that we discussed on this previous alert.

After receiving comments from stakeholders, the Agency responded by issuing: (i) a revised draft guidance document for clinical decision support (CDS) software (“Clinical and Patient Decision Support Software” or the “CDS Draft Guidance”) and (ii) a final guidance document for other software functions exempted by the Cures Act (“Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” or the “Software Policies Guidance”).

Here are key takeaways on FDA’s newly-issued guidance:
Continue Reading FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

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 Ideation Question #2: Who Will Provide Aspects of the Offering?

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 …
Continue Reading Top 10 Questions During Ideation of Digital Health Solutions

France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first…
Continue Reading French medicines regulator produces first in Europe medical devices cybersecurity guidelines

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 AI Framework does not establish new requirements or an official policy, but rather was released by FDA to seek early input prior to the development of a draft guidance. FDA acknowledges that the approach “may require additional statutory authority to implement fully.”

In an accompanying press release, former FDA Commissioner Scott Gottlieb outlined the need for a “more tailored” regulatory paradigm for algorithms that learn and adapt in the real world. FDA’s medical device regulation scheme was not designed for dynamic machine learning algorithms, as the Agency traditionally encounters products that are static at the time of FDA review. The AI Framework is FDA’s attempt to develop “an appropriate framework that allows the software to evolve in ways to improve its performance while ensuring that changes meet [FDA’s] gold standard for safety and effectiveness throughout the product’s lifecycle.”
Continue Reading FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software

Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they are but a few examples of the increasingly available and increasingly sophisticated “wearables” on the EU market. These technologies are an integrated part of many people’s lives, and in some cases allow healthcare professionals to follow-up on the condition or habits of their patients, often in real-time. How do manufacturers determine what wearables qualify as medical devices? How do they assess whether their devices need a CE-mark? Must they differentiate between the actual “wearable” and the hardware or software that accompanies them? In this short contribution, we briefly analyze some of these questions. The article first examines what “wearables” are, and when they qualify as a medical device under current and future EU rules. It then addresses the relevance of the applicability of EU medical devices rules to these products. The application of these rules is often complex and highly fact-specific.
Continue Reading Are Wearables Medical Devices Requiring a CE-Mark in the EU?