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Health data hosting: The new French HDS Certification has been released

The revised French Health Data Hosting (HDS) certification framework, published on May 16, 2024, in the Official Journal, addresses data localization and transfers amidst concerns about...

News

Public consultation and major updates from French Data Protection Authority on health data and research

On May 16, 2024, the CNIL announced a critical public consultation and three significant updates to adapt health research regulations in France. These updates, focusing on remote quality...

News

Scrutiny on health care professional transparency and inducement in the Netherlands

On 8 April 2024, the Dutch Minister of Medical Care sent a letter to Dutch Parliament (in Dutch: “Tweede Kamer”) regarding interactions between life sciences companies and...

Insights and Analysis

Life Science Law Update – Key developments for pharma & device companies in EU

The Q1/24 Life Science and Health Care Law Update covers key trends across EU life sciences regulatory, corporate, compliance, competition, and privacy.Key new developments: Pharma: EC ...

News

HHS finalizes changes to Section 1557 regulations strengthening anti-discrimination protections

On April 26, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) finalized updates to...

News

CMS Issues Draft Guidance on Inflation Reduction Act (IRA) Drug Price Negotiation Program for 2027

On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program...

News

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate...

News

FTC disputes new slate of Orange Book patents for weight loss, diabetes, asthma, and COPD drugs

On April 30, 2024, the Federal Trade Commission (FTC) announced that it sent a new set of warning letters to ten pharmaceutical companies. The letters inform the companies that the...

News

Repairing the supply chain

Now it’s adopted by the EU Parliament: the EU Directive on a right to repair. This proposal is a game changer. It affects manufacturers and sellers alike, and provides new ...

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