Vernessa T. Pollard
Subscribe to Vernessa T. Pollard's PostsVernessa T. Pollard advises companies on regulatory, compliance, enforcement and policy matters involving pharmaceuticals, medical devices, health information technology (HIT) and digital health solutions, services and software. She advises companies and investors on regulatory and compliance issues arising from mergers, acquisitions and other transactions involving Food and Drug Administration (FDA)-regulated products. She also counsels manufacturers, distributors and retailers on regulatory and compliance issues related to food and cosmetic marketing and safety. Read Vernessa Pollard's full bio.
FDA Issues Artificial Intelligence/Machine Learning Action Plan
By Vernessa T. Pollard and Anisa Mohanty on Jan 20, 2021
Posted In Big Data
On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan outlines five actions that FDA intends to take to further its oversight of AI/ML-based SaMD: Further develop the proposed regulatory framework, including through draft guidance on a...
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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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To Market, To Market: FDA’s Digital Health Precertification Program
By Vernessa T. Pollard on Sep 18, 2019
Posted In Cybersecurity, General Interest
In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software applications and other transformative technologies, such as artificial intelligence and 3D printing, are reshaping how medical devices are developed, and FDA...
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Reviewing Key Principles from FDA’s Artificial Intelligence White Paper
By Anisa Mohanty and Vernessa T. Pollard on Aug 28, 2019
Posted In General Interest
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,” announcing steps to consider a new regulatory framework to promote the development of safe and effective medical devices that use advanced AI algorithms. AI, and specifically...
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FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers
By Anisa Mohanty and Vernessa T. Pollard on Jul 24, 2019
Posted In General Interest
As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. In...
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Live Webinar: Developing and Procuring Digital Health AI Solutions: Advice for Developers, Purchasers and Vendors
By McDermott Will & Emery, Bernadette M. Broccolo, Dale C. Van Demark, Jeremy Earl, Jennifer S. Geetter, Jiayan Chen, Michael W. Ryan, Paul W. Radensky, MD and Vernessa T. Pollard 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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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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FDA Outlines the New Digital Health Innovation Action Plan and Software Precertification Pilot Program
By McDermott Will & Emery and Vernessa T. Pollard on Aug 7, 2017
Posted In Data Privacy, General Interest, Telehealth
Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation...
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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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