Archives: Medical Devices and FDA

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Digital Health Checkup (Part Two): Key Commercial Questions When Contracting for Digital Health Solutions

In the second of a three-part series, Covington’s global cross-practice Digital Health team considers some additional key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Commercial Questions When Contracting for Digital … Continue Reading

Digital Health Checkup: Key Questions Market Players Should Be Asking (Part One)

In the first of a three-part series, Covington’s global cross-practice Digital Health team answers key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Regulatory Questions About Digital Health Solutions 1. What are … Continue Reading

AG Opinion on Software Medical Devices

On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software medical devices. … Continue Reading

FDA Initiates Software Precertification Pilot Program

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

FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan

On July 27, FDA published its Digital Health Innovation Action Plan. The plan provides details and timelines for the agency’s Digital Health Innovation Plan, announced by FDA Commissioner Scott Gottlieb last month. The action plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes … Continue Reading

After Two-Day Workshop, CDRH Releases Postmarket Cybersecurity Draft Guidance

Earlier today, on the InsideMedicalDevices blog, our colleague Christopher Hanson posted a summary of the FDA’s recent issuance of draft guidance on “Postmarket Management of Cybersecurity in Medical Devices.”  The release of the draft guidance coincided with the conclusion of a two-day public workshop hosted by the FDA entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.”  You … Continue Reading

OIG FY 2016 Work Plan Includes Review of FDA’s Oversight of Networked Devices

On November 2, 2015, the HHS Office of Inspector General (OIG) published its FY 2016 Work Plan, which summarizes new and ongoing activities that OIG plans to pursue with respect to HHS programs and operations during the fiscal year. The FY 2016 Work Plan includes a new review initiative to examine “whether FDA’s oversight of … Continue Reading

FDA Regulatory Science Priorities Address Use of Data, Health Information Technology

On October 20, 2015, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) released its top ten Regulatory Science Priorities for FY 2016 to facilitate improvements in the safety and effectiveness of medical devices and accelerate innovation. Several of the priorities would harness health information technology or health data to … Continue Reading

Multistakeholder Group Seeks Comment on Draft Framework for IoT Device Manufactures

Last week, our colleague Libbie Cantor published a post on our InsidePrivacy blog regarding the Online Trust Alliance’s (OTA) release of a draft framework of best practices for Internet of Things device manufacturers and developers.  This draft framework applies to, among other things, eHealth technology, such as wearable fitness and health technologies.  The OTA is seeking comments on … Continue Reading

Cybersecurity Risks with Connected Devices

Earlier this week, our colleague Bianca Nunes published a post on cybersecurity risks with connected devices on Covington’s InsideMedicalDevices blog.  This post describes the FDA’s increasing focus on promoting cybersecurity, as well as a draft practice guide for securing health records maintained on mobile devices published by the National Institute of Standards and Technology (NIST).… Continue Reading

FDA to Focus on “Complementary” Diagnostics in Addition to Companion Diagnostics

Bloomberg BNA reports (subscription required) that FDA will recognize a regulatory category called “complementary diagnostics” for tests that provide additional information about how a drug might be used, but that are distinct from “companion diagnostics,” which are essential for the safe and effective use of a drug.… Continue Reading

House Cures Draft Includes Provisions to Expand Access to Data, Facilitate Research

On April 29, 2015, members of the U.S. House Energy and Commerce Committee released a revised discussion draft of the 21st Century Cures Act (“Cures”). The draft bill includes a number of provisions intended to facilitate drug, biologic, and medical device discovery and development through greater collection and dissemination of data and the use of … Continue Reading

FDA Regulation of mHealth Updates

At the Food Drug and Law Institute’s annual conference on April 21, 2015, Bakul Patel, Associate Director for Digital Health, Office of Center Director, Center for Devices and Radiological Health (CDRH), held a discussion of “FDA Regulation of Mobile Health/Medical Applications.”  As we discussed in a previous post (see here), there have already been several … Continue Reading

The Cyber Future of Long-Term Care: Applying Health Care Laws to Aging in Place Technologies

Earlier this month, the National Law Journal published its annual Special Report on Health Care Law. Included in this Special Report is an article written by CovingtonEHealth contributors Caroline Brown, Anna Kraus, and Phil Peisch, entitled, The Cyber Future of Long-Term Care: Applying Health Care Laws to Aging in Place Technologies. This article explores how … Continue Reading

Upcoming Webinar: Regulation of eHealth Products and Mobile Apps (February 25, 2015)

As part of Covington’s ongoing Life Sciences Essentials webinar series, we will be presenting a program on Regulation of eHealth Products and Mobile Apps on February 25, 2015 (12:30-2:00 p.m. EST). Our panelists, including two alumni of the FDA Office of Chief Counsel, will address: What factors determine whether an eHealth product is considered a medical device … Continue Reading

Important Developments in FDA Regulation of Software, Including Mobile Apps

This year is set to bring several important developments from Congress and FDA relating to FDA regulation (or deregulation) of software, including mobile apps. FDA has recently issued several draft and final guidances in this space and Congress has circulated several draft bills. Most recently, the House Energy and Commerce Committee released a discussion draft … Continue Reading

FDA Publishes Draft Guidances Describing General Wellness Claims and Risk-Based Classification of Accessories

Our colleague and contributor Cassie Scherer just published a post on the InsideMedicalDevices blog analyzing today’s FDA draft guidances on the Center for Devices and Radiological Health’s (CDRH) policy regarding low risk general wellness products and regulation of medical device accessories.  Although the guidances are not solely focused on software, they provide further clarification to the rapidly developing and expanding mobile app and … Continue Reading

Welcome to Covington eHealth

While Covington eHealth is a new publication, lawyers at Covington & Burling LLP have been writing on topics related to eHealth for many years, including on other Covington blogs. Below is a selection of eHealth-related articles posted to other Covington blogs in the first half of 2014. We encourage you to visit our other sites … Continue Reading

FDA Issues Long-Awaited Draft Guidance Documents Concerning Internet/Social Media

Our colleagues at the InsideMedicalDevices blog have posted a short summary of two draft guidance documents recently issued by the FDA pertaining to internet/social media.  The first draft guidance document discusses how manufacturers of drugs, biological products, and medical devices should respond to misinformation about their products posted by third parties on internet/social media platforms.  The second document focuses … Continue Reading

FDA Releases FDASIA Health IT Report With Recommendations for a Risk-Based Regulatory Framework

On April 3, 2014, the Food and Drug Administration (“FDA”) proposed a risk-based approach to determining the level of oversight that should apply to health information technology (“HIT”).  The FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework divides HIT into three functional categories that pose varying levels of safety risks and … Continue Reading

Mobile Health in the United States and China

Last week, the Center for Technology Innovation at the Brookings Institution presented a paper and hosted a panel discussion on how mobile technology can decrease the cost and improve the quality of health care in the United States and China.  The presenters noted, however, that significant policy and legal challenges face the telemedicine industry in … Continue Reading
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