23 July 2019
New CNIL standard for all companies doing product vigilance activities
www.twobirds.com/en/news/articles/2019/global/new-cnil-standard-for-all-companies-doing-product-vigilance-activities

New CNIL standard for all companies doing product vigilance activities

02 December 2019
The French Health Data Hub becomes reality
www.twobirds.com/en/news/articles/2019/france/the-french-health-data-hub-becomes-reality

The French Health Data Hub was born officially with the publication on 30 November 2019 of a ministerial decision (arrêté).

21 April 2020
COVID-19: ANSM guidance on Data Protection requirements for on-going trials
www.twobirds.com/en/news/articles/2020/france/covid-19-ansm-guidance-on-data-protection-requirements-for-on-going-trials-in-france

French data protection law on health research applies to all sponsors, whatever their country of establishment, when they perform clinical trials in France.

27 April 2020
COVID-19: The NIPN’s Regulatory and Data Protection Guidance on adjustments in clinical trials
www.twobirds.com/en/news/articles/2020/global/covid-19-the-nipns-regulatory-and-data-protection-guidance-on-adjustments-in-clinical-trials

On the tails of the EMA’s Guidance on the Management of Clinical Trials during the COVID-19 pandemic, the Hungarian National Institute of Pharmacy and Nutrition (NIPN) has issued its guidance on how local regulations ...

11 July 2019
French healthcare system reform: The final steps of the legislative process are expected soon
www.twobirds.com/en/news/articles/2019/france/french-healthcare-system-reform-the-final-steps-of-the-legislative-process-are-expected-soon

The Bill of the Law on the organization and transformation of the French healthcare system at the French parliament, adoption of the final version is expected for the end of July.

18 March 2019
French Legal Framework for the exchange of health data by secured health messaging systems
www.twobirds.com/en/news/articles/2019/france/french-legal-framework-for-the-exchange-of-health-data-by-secured-health-messaging-systems

Before the entry into force of the GDPR on May 25th 2018, healthcare professionals and facilities and professionals in medico-social sectors empowered by law in France had to comply with the provisions stated in the ...

01 March 2019
Processing health data in France: What to look out for after GDPR?
www.twobirds.com/en/news/articles/2019/france/processing-health-data-in-france-what-to-look-out-for-after-gdpr

French law imposes stricter requirements than the General Data Protection Regulation (“GDPR”) regarding health data processing.

20 March 2020
Legal considerations when launching a gym or fitness establishment
www.twobirds.com/en/news/articles/2020/singapore/legal-considerations-when-launching-a-gym-or-fitness-establishment

Fitness and wellness options in Singapore have been steadily rising thanks in large part to the growing awareness of the manifold benefits of health. This is reflected in the life choices that are now commonplace not ...

14 June 2019
China Cyber Security Law Update: Long-Awaited Second Draft Measures on Security Assessment for Export of Personal Information: Any clarity?
www.twobirds.com/en/news/articles/2019/global/china-cyber-security-law-update

On 13 June 2019, the Cyberspace Administration of China (CAC) issued a long-awaited second draft Measures on Security Assessment for Export of Personal Information. In this update we examine some of the key takeaways.

24 February 2020
Blockchain in the Life Sciences & Healthcare Sectors
www.twobirds.com/en/news/articles/2020/global/blockchain-in-the-life-sciences-and-healthcare-sectors

Blockchain is perhaps best known as the technology on which Bitcoin and other digital cryptocurrencies are built. Adoption of blockchain technology – especially in the financial services sector – has been rapid but in ...