News & Analysis as of May 5, 2025

Cybersecurity › Draft Guidance › Data Security

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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 -

FedRAMP Releases New Draft Authorization Boundary Guidance

Sheppard Mullin Richter & Hampton LLP on 1/30/2025

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the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more

New FDA electronic records guidance prioritizes Digital Health Technology oversight

Hogan Lovells on 3/28/2023

On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for...more

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

Hogan Lovells on 6/23/2021

On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more

Privacy & Cybersecurity Update - January 2021

Skadden, Arps, Slate, Meagher & Flom LLP on 2/4/2021

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Digital Services Act and its potential regulatory impact, the National Institute of Standards and Technology's draft guidance on internet-of-things devices'...more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 Proposes Draft Enhanced Security Requirements for Protecting CUI

Sheppard Mullin Richter & Hampton LLP on 7/30/2020

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

Right Of Access Under GDPR: Draft Guidance From The UK ICO

Fox Rothschild LLP on 12/30/2019

The United Kingdom's Information Commissioner's Office has issued, for public consultation, draft guidance on the right of access under the General Data Protection Regulation (GDPR). Key takeaways: To Prepare for a Data...more

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

Sheppard Mullin Richter & Hampton LLP on 11/30/2018

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

FDA, DHS Increase Coordination Over Medical Device Cybersecurity Risks to Patient Safety

Holland & Knight LLP on 10/19/2018

The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft...more

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

Jones Day on 8/2/2017

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

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