On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for managing postmarket cybersecurity vulnerabilities in medical devices that contain software or programmable logic and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 The Draft Guidance represents FDA’s latest attempt to outline principles intended to enhance medical device cybersecurity throughout the product lifecycle.
FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices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 January 29, 2016
Daniel F. GottliebDaniel F. Gottlieb counsels a wide range of health care industry clients, including health care providers, health plans, health information technology (IT) vendors and life sciences companies. He represents these entities on health IT acquisitions, privacy and data protection, reimbursement, fraud and abuse, and other health care regulatory and transactional matters. Daniel is a co-leader of the Firm’s Global Privacy and Cybersecurity Practice. Read Daniel Gottlieb's full bio.
Jennifer S. GeetterJennifer S. Geetter advises global life sciences, health care and informatics clients on legal issues attendant to biomedical innovation, research compliance, financial relationship management, digital health practices, and global privacy and data security laws. Jennifer represents a broad range of clients. Read Jennifer Geetter's full bio.
Michael W. RyanMichael 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.
Vanessa K. BurrowsVanessa K. Burrows counsels clients on health care law and regulatory issues, with an emphasis on drug, medical device, food, beverage, and pharmacy law. Her broad-based experience also includes the Health Insurance Portability and Accountability Act (HIPAA) compliance, health privacy and security, alcohol beverages and public health. She advises health care entities and their contractors on compliance, regulatory, data sharing, licensing, and enforcement matters. She also counsels clients on compliance with Food and Drug Administration (FDA) regulations and guidance. Read Vanessa Burrows' full bio.
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