News & Analysis as of May 5, 2025

Data Protection

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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 -

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on 1/13/2025

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

CPPA publishes new draft regulations addressing AI, risk assessments, cyber audits

Ballard Spahr LLP on 9/8/2023

The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the CPPA has not officially started the formal...more

CPPA Publishes New Draft Regulations Addressing AI, Risk Assessments, and Cyber Audits

Ballard Spahr LLP on 9/6/2023

The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the Agency has not officially started the formal...more

Does the UK's Age-Appropriate Design Code Apply to Your Business?

Orrick, Herrington & Sutcliffe LLP on 5/19/2023

Following the introduction of the Age-Appropriate Design Code (the Code) on 2 September 2021, companies have questioned whether the Code applies to their online service. A recent consultation by the ICO seeks to clarify when...more

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on 12/2/2022

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

CPRA Draft Regulations – Next Round(s)

Bass, Berry & Sims PLC on 11/10/2022

It has been a bustling fall for the California Privacy Protection Agency (CPPA or Agency). In the spirit of the upcoming holiday season, the Agency gifted us not one but two rounds of proposed modifications to the regulations...more

FDA updates “cybersecurity in medical devices” guidance, seeks industry input - Draft guidance addresses quality system...

Hogan Lovells on 4/15/2022

The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more...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

EU Data Protection Regulators Issue Critical Draft Guidance on Personal Data Transfers

Mintz - Privacy & Cybersecurity Viewpoints on 11/13/2020

US companies and other organizations whose activities involve the use of personal information from Europe were unsettled by the EU Court of Justice’s July 2020 Schrems II decision that cast doubt on the lawfulness of...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

EU Privacy Regulators Issue Draft Guidelines on Connected Vehicles and Mobility Applications

Wilson Sonsini Goodrich & Rosati on 3/10/2020

On February 7, 2020, the European Data Protection Board (EDPB) published draft guidelines on the processing of personal data in the context of connected vehicles and mobility related applications. If adopted in their current...more

EDPB Publishes Draft Guidelines On Connected Vehicles

Fox Rothschild LLP on 2/12/2020

The European Data Protection Board has published draft guidelines for public comment on the data protection aspects of connected vehicles. Key takeaways: The Relevant Players- Non exhaustive list of stakeholders: vehicle...more

Privacy & Cybersecurity Update - December 2019

Skadden, Arps, Slate, Meagher & Flom LLP on 1/3/2020

In this month's edition of our Privacy & Cybersecurity Update, we take a look at guidance on artificial intelligence released by the U.K. Information Commissioner's Office and the Turing Institute, as well as guidance...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

Privacy & Cybersecurity Update - October 2019

Skadden, Arps, Slate, Meagher & Flom LLP on 11/4/2019

In this month's edition of our Privacy & Cybersecurity Update, we examine the California attorney general's draft regulations on the California Consumer Privacy Act, the CJEU's clarified rulings on the use of cookies, the...more

CCPA Draft Regulations Expected in October

Robinson+Cole Data Privacy + Security Insider on 9/25/2019

Bloomberg Law reported this week that California Attorney General Xavier Becerra expects to issue draft regulations for the California Consumer Privacy Act (CCPA) in October....more

EDPB Issues Draft Guidelines On Legal Basis Of Data Processing ‘Necessary For The Performance Of A Contract’

Fox Rothschild LLP on 4/15/2019

The European Data Protection Board (EDPB) has issued draft guidelines on the GDPR legal basis of “necessary for the performance of a contract”....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

NIST Releases Draft Cybersecurity Guidance for Wireless Infusion Pumps

Robinson+Cole Data Privacy + Security Insider on 5/12/2017

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

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