News & Analysis as of

Data-Sharing Safe Harbors

Latham & Watkins LLP

FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

Latham & Watkins LLP on

The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more

McGuireWoods LLP

Fraud and Abuse Rules Part II: Amended EHR and New Cybersecurity Donation Safe Harbors and Exceptions

McGuireWoods LLP on

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law...more

Eversheds Sutherland (US) LLP

NY’s Nuisance Call Act goes into effect; NY state of emergency prompts further marketing call restrictions

New York’s Nuisance Call Act (NYNC Act), signed into law in December 2019 and effective as of March 1, 2020, amends New York’s telemarketing law (specifically, N.Y. Gen. Bus. Law § 399-z) by requiring live voice outbound...more

Bass, Berry & Sims PLC

Sprinting to Coordinated Care: Healthcare Industry Urges Stark Law Relief as OIG Solicits Feedback on Changes to the Anti-Kickback...

August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more

King & Spalding

OIG Warns Information Blocking May Affect Safe Harbor Protection

King & Spalding on

In an alert published October 6, 2015, the OIG reminded the public that “information blocking”—generally described as individuals or entities knowingly and unreasonably interfering with the exchange or use of electronic...more

Robinson+Cole Data Privacy + Security Insider

EU endorsement of Safe Harbor will be decided on October 6

Last week, (September 23, 2015), Advocate General Yves Bot (AG), an adviser to Europe’s highest court, issued a nonbinding opinion that the agreement between the EU and the U.S. for data transfers from the EU to the U.S....more

Latham & Watkins LLP

Snowden's Legacy: Safe Harbor under fire at the CJEU

Latham & Watkins LLP on

This week the Court of Justice of the European Union (‘CJEU’) heard a case that could destabilise data flows between the US and EU under the EU-US Safe Harbor Decision. In Schrems v Data Protection Commissioner (C-362/14),...more

Snell & Wilmer

Can the U.S. – EU Safe Harbor Weather the Storm?

Snell & Wilmer on

On 24 March, the Court of Justice for the European Union (CJEU) heard argument on a case that could significantly impact, if not invalidate altogether, the Safe Harbor framework that facilitates the flow of personal data from...more

McGuireWoods LLP

European Hearing on the Future of Safe Harbor

McGuireWoods LLP on

Back on February 12th 2015, Max Schrems, the Austrian law student who began Europe v. Facebook, posted a tweet suggesting that the Court of Justice of the European Union (CJEU) may hear his case as soon as this month. Since...more

Dechert LLP

Data Transfers Within A Multinational Group - Safely Navigating EU Data Protection Rules

Dechert LLP on

Introduction - Multinational corporations increasingly have a need to share their data throughout their group. Often this will be necessary to service international clients or to coordinate marketing efforts....more

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