News & Analysis as of

Data Protection Pharmaceutical Industry

Smart & Biggar

Health Canada releases its Statistical Report 2024/2025 for PMNOC Regulations, data protection and CSPs

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On July 25, 2025, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report 2024/2025 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection (C.08.004.1 of the Food...more

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

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Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

Gardner Law

New DOJ Rule Restricts Deidentified Data Transfer

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No Safe Harbor: New DOJ Data Export Rule Restricts Deidentified Data Transfer - This article outlines new requirements from the Department of Justice regarding “bulk sensitive data”, including de-identified, anonymized,...more

A&O Shearman

Council position on EU pharma package adopted

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On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more

Hogan Lovells

EU Pharma Law Package: Council Position on Reduction of Regulatory Exclusivity Rights

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On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU’s general pharmaceutical legislation. The Council, consisting of all the 27 EU Member States and...more

Dorsey & Whitney LLP

23andMe Sparks Lawmaker Race to Protect Genetic Data in Bankruptcy

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When direct-to-consumer genetic testing company 23andMe Holding Co. and its affiliates (together, “23andMe”) filed for chapter 11 bankruptcy on March 24, 2025, they possessed data from over 15 million customers. Specifically,...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

A&O Shearman

China advances pharmaceutical data protection regime with new Draft Measures

A&O Shearman on

On March 19, 2025, China’s National Medical Products Administration (NMPA) released the Draft Measures for the Protection of Drug Trial Data (the “Draft Measures”), along with its accompanying implementation guidelines, the...more

Latham & Watkins LLP

Preparing for the European Health Data Space - Opportunities and Challenges for Europe’s Digital Future

Latham & Watkins LLP on

The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 120

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Ropes & Gray LLP

China Formalizes Regulatory Data Protection Mechanism

Ropes & Gray LLP on

Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more

Sheppard Mullin Richter & Hampton LLP

Reminder: FDA Does, In Fact, Review DOF

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 119

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Ballard Spahr LLP

Key Takeaways From the 2025 J.P. Morgan Health Care Conference

Ballard Spahr LLP on

Cautious Optimism for Deal Making. The general consensus is that we will likely see an increase in M&A and capital market transactions in the life sciences sector in 2025....more

Morgan Lewis - As Prescribed

IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025

The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A)....more

Troutman Pepper Locke

Q4 2024 Health Care Conference Roundup: AI and Government Enforcement Are on the Rise

Troutman Pepper Locke on

Last quarter, our attorneys had the privilege of attending three prominent health care conferences, each of which offered a wealth of knowledge and insights into the current and future landscape of the health care industry. ...more

Smart & Biggar

2024 highlights in Canadian life sciences IP and regulatory law

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In 2024, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law. Highlights from 2024 are below; see also our top ten Rx IP Update reads of 2024....more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 118

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Jones Day

Vital Signs: Digital Health Law Update | Fall-Winter 2024

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 117

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

White & Case LLP

CJEU: Competitors Can Sue over Data Protection Violations

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The German Federal Court of Justice (Bundesgerichtshof), tasked with resolving a conflict between two competing pharmacists, sought guidance from the Court of Justice of the European Union ("CJEU") on interpreting the General...more

White & Case LLP

AI implementation & data protection regulation: German authorities publish guidelines for implementing AI in compliance with the...

White & Case LLP on

The German federal and state data protection authorities published guidelines for the implementation and use of AI in compliance with the European Union's regulation of personal data ("Guidelines")....more

Gardner Law

[Ongoing Program] SESSION 3: Privacy Policy Pop Quiz – Are You Ready? - August 8th, 1:00 pm - 1:45 pm CT

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Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Gardner Law

[Ongoing Program] SESSION 2: Do I Really Need A Privacy Officer, DPO or CISO? - July 18th, 1:00 pm - 1:45 pm CT

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Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Gardner Law

[Ongoing Program] SESSION 1: 10 Things You Should Know About Privacy, Consent, and HIPAA - June 13th, 1:00 pm - 1:45 pm CT

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Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

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