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Data Security Draft Guidance

DLA Piper

China: Important New Guidance on Defining Sensitive Personal Information

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information in China has always been different to other jurisdictions, with a focus on risk of harm at its heart, new draft guidance should make it easier for organisations to map...more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

Dechert LLP

Dechert Cyber Bits - Issue 40

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FTC Settles with Experian for Alleged Customer Spamming - On August 14, 2023, the Federal Trade Commission (“FTC”) announced a proposed settlement involving Experian Consumer Services (“Experian”). A federal court entered...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On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for...more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In proportion - UK ICO issues draft guidance on information about workers' health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its project to update the Employment Practices Data Protection Code, the UK ICO has published its second topic-specific draft guidance for consultation.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

McDermott Will & Emery on

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

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On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - January 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

Sheppard Mullin Richter & Hampton LLP

NIST Seeking Comments on Draft AI Principles

The National Institute of Standards and Technology has issue a set of draft principles for “explainable” artificial intelligence and is accepting comments until October 15, 2020. The authors of the draft principles outline...more

Sheppard Mullin Richter & Hampton LLP

NIST Proposes Draft Enhanced Security Requirements for Protecting CUI

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

Fox Rothschild LLP

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

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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

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

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

Holland & Knight LLP on

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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