News & Analysis as of

Cybersecurity › Draft Guidance › Comment Period

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +
Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now.   less -
Sheppard Mullin Richter & Hampton LLP

FedRAMP Releases New Draft Authorization Boundary Guidance

Sheppard Mullin Richter & Hampton LLP on

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the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more

Hogan Lovells

New FDA electronic records guidance prioritizes Digital Health Technology oversight

Hogan Lovells on

On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for...more

Goodwin

Mitigation of Cybersecurity Risks in Medical Device Software: FDA Discussion & Insights for OEMs, Remanufacturers, and Servicers

Goodwin on

I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more

Hogan Lovells

“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

Hogan Lovells on

On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more

Mintz - Health Care Viewpoints

FDA 2018 Year in Review (and a Few Thoughts on 2019)

Mintz - Health Care Viewpoints on

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

Sheppard Mullin Richter & Hampton LLP on

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

Saul Ewing LLP

FDA Releases Medical Device Cybersecurity Draft Guidance

Saul Ewing LLP on

In recognition of the increasing prevalence of connected medical devices, and the potential cybersecurity vulnerability of the same, the U.S. Food and Drug Administration (FDA or the Agency) issued on October 18, 2018 a draft...more

Poyner Spruill LLP

Securing Wireless Infusion Pumps in Healthcare

Poyner Spruill LLP on

The National Cybersecurity Center of Excellence (NCCoE) announced in August that it has finalized the draft guidance it first issued in May of last year on securing wireless infusion pumps. Infusion pumps are often tasked...more

Jones Day

FDA Establishes Electronic Privacy, Security, and Reliability Criteria for Clinical Trial Records

Jones Day on

In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more

BakerHostetler

FDA Issues Guidance on Cybersecurity Issues for Postmarket Medical Devices

BakerHostetler on

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

Morgan Lewis

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

Morgan Lewis on

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more

Mintz - Health Care Viewpoints

FDA Releases Draft Guidance for Medical Device Cybersecurity

Mintz - Health Care Viewpoints on

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called...more

Tucker Arensberg, P.C.

Food And Drug Administration Issues Draft Guidance On Cybersecurity In Medical Devices

Tucker Arensberg, P.C. on

On January 22, 2016, the Food and Drug Administration (“FDA”) released draft guidance regarding postmarket management of cybersecurity risks in medial devices. This guidance comes over a year after the FDA issued similar...more

King & Spalding

FDA Issues Draft Guidance Governing Postmarket Cybersecurity Risk Management Standards

King & Spalding on

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

14 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide