Medical Apps

The EU’s regulatory rules for medical devices are due to change on 26 May 2020, when the new Medical Device Regulation (“MDR”)[1] comes into effect.  The regime for in vitro diagnostic devices will change two years later from 26 May 2022 when the In Vitro Diagnostic Devices Regulation (“IVDR”)[2] will apply.

In advance of these changes, the EU Medical Device Coordination Group (“MDCG”) has recently published guidance on the Qualification and Classification of Software in the MDR and IVDR (the “Guidance”).

The aim of the Guidance is to assist manufacturers with interpreting the new Regulations to assess whether their software meets the definition of a medical device or an in vitro diagnostic device (i.e., “qualification”); and if so, what regulatory class the software would fall under (i.e., “classification”).

The MDCG is a coordination group established under Article 103 of the MDR, comprising up to two medical device experts from each EU Member State.  Its key functions include contributing to the development of guidance to ensure effective and harmonized implementation of the EU’s new medical device rules.  The Guidance is not legally binding nor does it necessarily reflect the official position of the European Commission.  However, given the MDCG’s important role in the regulatory landscape, the Guidance is likely to be highly persuasive.Continue Reading EU Medical Device Coordination Group Publishes Guidance on the Qualification and Classification of Software under Upcoming Medical Device Regulations

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As background, FDA issued draft guidance documents in December 2017 that sought to implement section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), which was enacted by Congress in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

Last week, Senators Amy Klobuchar (D-MN) and Lisa Murkowski (R-AK) introduced the Protecting Personal Health Data Act (S. 1842), which would provide new privacy and security rules from the Department of Health and Human Services (“HHS”) for technologies that collect personal health data, such as wearable fitness trackers,
Continue Reading Senators Introduce Legislation to Regulate Privacy and Security of Wearable Health Devices and Genetic Testing Kits

On Friday, April 19, 2019, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) explained in an FAQ the circumstances under which electronic health record (EHR) systems may be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) liability for an
Continue Reading HHS Clarifies HIPAA Liability for EHR System Developers that Transfer Data to Health Apps

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

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 strategic priority for the FDA.”  FDA opened a docket for public comments on the Framework through February 5, 2019.

The Framework focuses in particular on the use of RWE to support regulatory decisions about effectiveness.  The agency outlines three considerations that will guide its overall RWE Program and inform the agency’s assessment of individual drug applications.  The Framework also offers background on the agency’s previous use and current initiatives with respect to RWE and related topics, such as innovative clinical trial designs.  This blog post provides an overview of FDA’s proposal and highlights a few initial takeaways noted by Covington’s Digital Health team.Continue Reading Key Takeaways from FDA’s Framework for Real-World Evidence for Pharmaceuticals