Michael W. Ryan
Subscribe to Michael W. Ryan's PostsMichael W. Ryan advises manufacturers, health care providers, developers, and investors on the legal, regulatory, and reimbursement issues that arise during the development and commercialization of medical devices, drugs, biological products, and clinical laboratory testing services. Read Michael Ryan's full bio.
The Toughest Problem Set: Navigating Regulatory and Operational Challenges on University Campuses
By Jennifer S. Geetter and Michael W. Ryan on Aug 27, 2020
Posted In Data Privacy, Mobile Apps, Workplace Privacy
When the academic year ended in the spring of 2020, many US university students assumed that a return to campus would be straightforward this fall. However, it is now clear—at least in the near term—that a return to the old “normal” will not be possible. Some universities have concluded that their best course of action...
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Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents
By Anisa Mohanty, Michael W. Ryan and Vernessa T. Pollard on Oct 4, 2019
Posted In General Interest, Mobile Apps
The 21st Century Cures Act, enacted in December 2016, amended the definition of “medical device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) to exclude five distinct categories of software or digital health products. In response, the US Food and Drug Administration (FDA) issued new digital health guidance and revised several pre-existing medical...
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Mid-Year Digital Health Report: Focus on Medicare
By Dale C. Van Demark, Lisa Mazur, Marshall E. Jackson, Jr. and Michael W. Ryan on Jul 30, 2018
Posted In Telehealth
It has been only a little over six months, and already 2018 has been a busy year for digital health, particularly in the area of Medicare reimbursement. The Centers for Medicare and Medicaid Services (CMS), Congress, the Medicare Payment Advisory Commission, and the US Department of Health and Human Services (HHS) Office of Inspector General...
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Live Webinar: Developing and Procuring Digital Health AI Solutions: Advice for Developers, Purchasers and Vendors
By Vernessa T. Pollard, McDermott Will & Emery, Bernadette M. Broccolo, Dale C. Van Demark, Jeremy Earl, Jennifer S. Geetter, Jiayan Chen, Michael W. Ryan and Paul W. Radensky, MD on Jun 8, 2018
Posted In Cybersecurity, Data Privacy, Data Transfers/Safe Harbor/Privacy Shield, General Interest, Mobile Apps, Telehealth
Join McDermott next Wednesday for a live webinar on the unique considerations in developing and procuring AI solutions for digital health applications from the perspective of various stakeholders. We will discuss the legal issues and strategies surrounding: Research and data mapping essential to the development and validation of AI technologies Protecting and maintaining intellectual property...
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Order now: The Law of Digital Health Book
By McDermott Will & Emery, Amanda Enyeart, Anisa Mohanty, Amy C. Pimentel, Bernadette M. Broccolo, Dale C. Van Demark, Jiayan Chen, Lisa Mazur, Marshall E. Jackson, Jr., Michael W. Ryan, Ryan S. Higgins, Scott Weinstein and Vanessa K. Burrows on Mar 20, 2018
Posted In Big Data, Cloud, Consumer Protection, Data Privacy, General Interest, Telehealth
Designed to provide business leaders and their key advisors with the knowledge and insight they need to grow and sustain successful digital health initiatives, we are pleased to present The Law of Digital Health, a new book edited and authored by McDermott’s team of distinguished digital health lawyers, and published by AHLA. Visit www.mwe.com/lawofdigitalhealth to order this...
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Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018
By Jiayan Chen, Lisa Mazur, Michael W. Ryan, Scott Weinstein, Vernessa T. Pollard, McDermott Will & Emery, Bernadette M. Broccolo, Dale C. Van Demark and Jennifer S. Geetter on Jan 12, 2018
Posted In Advertising & Marketing, Big Data, Cloud, Consumer Protection, Cybersecurity, Data Privacy, Data Transfers/Safe Harbor/Privacy Shield, Mobile Apps, Telehealth
Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing...
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Guidance on Low Risk General Wellness Devices Is Finalized
By McDermott Will & Emery, Michael W. Ryan and Vernessa T. Pollard on Aug 4, 2016
Posted In Consumer Protection, General Interest, Mobile Apps, Telehealth
On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory requirements for low risk products that promote a healthy lifestyle—coined “general wellness products.” In the Final Guidance, the FDA makes minimal substantive changes to...
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Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws
By Jennifer S. Geetter, Michael W. Ryan, Vanessa K. Burrows and Vernessa T. Pollard on Apr 20, 2016
Posted In Consumer Protection, Data Privacy, General Interest, Mobile Apps
This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps that collect, create and share consumer information, including health information. The interactive series of questions and answers augments and cross-references existing...
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FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness
By Jennifer S. Geetter, Michael W. Ryan and Vanessa K. Burrows on Feb 17, 2016
Posted In Big Data, General Interest
At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel infrastructure to conduct post-market effectiveness studies. Sentinel is an electronic surveillance system that aggregates data from electronic medical records, claims and...
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FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices
By Daniel F. Gottlieb, Jennifer S. Geetter, Michael W. Ryan and Vanessa K. Burrows on Jan 29, 2016
Posted In Cybersecurity, Data Privacy, Mobile Apps
On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for managing postmarket cybersecurity vulnerabilities in medical devices that contain software or programmable logic and software that is a medical device, including networked medical devices. The...
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