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Sheppard Mullin Richter & Hampton LLP

FedRAMP Releases New Draft Authorization Boundary Guidance

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the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more

DLA Piper

China: Important New Guidance on Defining Sensitive Personal Information

DLA Piper on

While the definition of sensitive personal information in China has always been different to other jurisdictions, with a focus on risk of harm at its heart, new draft guidance should make it easier for organisations to map...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

Hogan Lovells

New FDA electronic records guidance prioritizes Digital Health Technology oversight

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On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for...more

Hogan Lovells

In proportion - UK ICO issues draft guidance on information about workers' health

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As part of its project to update the Employment Practices Data Protection Code, the UK ICO has published its second topic-specific draft guidance for consultation. The guidance covers processing information about workers’...more

McDermott Will & Emery

Special Report: Developments in UK Life Sciences – Spring Update 2022

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MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - January 2021

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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

Sheppard Mullin Richter & Hampton LLP

NIST Proposes Draft Enhanced Security Requirements for Protecting CUI

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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

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

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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

Holland & Knight LLP

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

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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

Jones Day

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

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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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