Medical Device Legal News with Sam Bernstein: Episode 11
Over the last few years, the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more
In this month's edition, we examine the European Commission's Digital Services Act and its potential regulatory impact, the National Institute of Standards and Technology's draft guidance on internet-of-things devices'...more
NIST recently released the final public draft of SP 800-172, Enhanced Security Requirements for Protecting Controlled Unclassified Information: A Supplement to NIST Special Publication 800-171 (formerly Draft NIST SP...more
On January 7, 2019, the federal Office of Management and Budget (OMB) released a draft of a memorandum setting forth guidance to assist federal agencies in developing regulatory and non-regulatory approaches regarding...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
Newly published draft DoD Guidance for Reviewing System Security Plans (SSP) and the “NIST SP 800-171 Security Requirements Not Yet Implemented” answer some questions but may also result in an increased protest docket due to...more
The National Institute of Standards and Technology (NIST) announced this week that it has issued draft cybersecurity guidance for hospitals to consider when using infusion pumps, particularly since infusion pumps are no...more
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The...more
The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more
Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers...more
On January 15, 2016, the U.S. Food and Drug Administration (FDA) announced in a Press Release that it would issue draft guidance on January 22 outlining “steps medical device manufacturers should take to continually address...more
Private sector entities looking to comment on the draft should focus on its recommendations surrounding sharing communities, standardized transfer mechanisms, and the handling of corporate legal considerations....more