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General Data Protection Regulation (GDPR) › Pharmaceutical Industry

Follow this channel for updates and analysis on all aspects of the European Union's General Data Protection Regulation, a reform of EU's data protection rules that impacts... more +
Follow this channel for updates and analysis on all aspects of the European Union's General Data Protection Regulation, a reform of EU's data protection rules that impacts individuals throughout the Union and all businesses operating therein. less -
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

White & Case LLP

CJEU: Competitors Can Sue over Data Protection Violations

White & Case LLP on

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

Gardner Law on

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

Gardner Law on

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

TransPerfect Legal

GDPR Compliance: At the Intersection of AI and Life Sciences

TransPerfect Legal on

Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more

Goodwin

What’s Next for AI? Six Areas to Watch in 2024

Goodwin on

Generative AI (GenAI) surged to the forefront of corporate agendas and public policy debates last year, promising to boost productivity and innovation. What’s in store for AI in 2024?...more

Foley & Lardner LLP

Recommendations for Managing Cybersecurity Threats in the Manufacturing Sector

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In the hyper-connected era of smart manufacturing, accelerated by “Industry 4.0,” the manufacturing sector is undergoing a digital revolution. By leveraging technologies such as advanced automation, artificial intelligence,...more

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

A&O Shearman on

Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

Nelson Mullins Riley & Scarborough LLP

Clinical Research and Patient Data Protection are at a Complicated Intersection

Nelson Mullins Riley & Scarborough LLP on

The privacy landscape in the United States and much of the world is quickly evolving around the framework of the General Data Protection Regulation (GDPR) within the European Economic Alliance (EEA). Clinical trials involve...more

Hogan Lovells

Long-awaited update of the French “Convention Unique” for clinical trials finally published

Hogan Lovells on

A new French template agreement for clinical trials (Convention Unique) was published on April 9, 2022. This new version was much awaited since the initial version, dated back to 2016, was missing some key provisions...more

Hogan Lovells

Heads up! New Spanish Code of Conduct on personal data in clinical trials and pharmacovigilance

Hogan Lovells on

The Spanish Data Protection Authority published on Friday on its website the new "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well as pharmacovigilance"...more

Hogan Lovells

Ne manquez pas la consultation sur les référentiels Accès Précoce et Accès Compassionnel

Hogan Lovells on

Le 15 février 2022, la CNIL a publié deux projets de référentiels. Ces référentiels étaient très attendus car l’Autorisation Unique 041 sur les traitements de données personnelles dans le cadre des Autorisations Temporaires...more

Hogan Lovells

UK ABPI transfer of value disclosures: transitioning from consent to legitimate interests

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UK pharmaceutical companies have historically relied upon consent as the lawful basis for the disclosure of healthcare professionals’ personal data relating to transfers of value. However, the low consent rates and the...more

McDermott Will & Schulte

International Legal Highlights - May 2021

McDermott Will & Schulte on

Expect More Criminal Enforcement & What You Can Do To Minimize Your Risk - Antitrust cartel and related collusive scheme enforcement is poised to increase. Several factors support this: (1) the Antitrust Division (the...more

Hogan Lovells

Looking ahead to 2021: AI – A brave new world?

Hogan Lovells on

In recent years, AI has become a buzzword in life sciences and health care as the technology has developed to create applications from drug discovery to diagnostics to therapeutics. Most recently, AI has been used in the...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Skadden, Arps, Slate, Meagher & Flom LLP on

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

Hogan Lovells

The importance of conscientious health data collection in European clinical trials

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Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Akin Gump Strauss Hauer & Feld LLP on

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Skadden, Arps, Slate, Meagher & Flom LLP

Cross-Border Investigations Update - September 2019

Skadden, Arps, Slate, Meagher & Flom LLP on

This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more

Hogan Lovells

EDPB’s Position on Clinical Trials Creates Friction with Other EU Legislation

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Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of...more

McDermott Will & Schulte

Brexit Update - March 2019

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SPECIAL REPORT - BREXIT: CHALLENGES AND OPPORTUNITIES - In this report, we explain some of the key legal implications associated with the United Kingdom leaving the European Union (EU) without a deal for future...more

Foley Hoag LLP - Security, Privacy and the...

EDPB Issues Opinion on the Interplay between the Clinical Trials Regulation and the GDPR

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On January 23, 2019, the European Data Protection Board (“EDPB”) issued an interesting opinion about personal data processed in relation to clinical trials. The main role of the EDPB – which succeeded the Article 29...more

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