Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Follow us:



FDA M-CERSI AI workshop highlights future FDA comment period on AI in drug development

The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently...


CMS issues initial guidance on Drug Price Negotiation Program

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction...


Health and safety training: not just a tick box exercise

Every employer in South Africa has the legal obligation to provide and maintain a safe working environment, as far as is reasonably practicable, which is without risk to the health of...


The False Claims Act Guide: 2022 and the road ahead

In the latest edition of our False Claims Act Guide: 2022 and the road ahead, we analyze the key developments from 2022 and discuss how the most important cases and issues are shaping FCA...


After the Public Health Emergency: Implications for Medicare and U.S federal health care policies

On January 30, 2023, the Biden Administration announced that it intends to allow the COVID-19 national emergency and public health emergency (collectively, “PHE”) to expire...


Patient claims and medical secrecy within the EU

In product liability cases involving health products, one of the key issues is to obtain patients’ medical records, including their electronic health records (EHR). Most of the time,...


HHS OCR creates new HIPAA enforcement arm and enhances focus on cybersecurity and privacy oversight

This week the U.S. Department of Health and Human Services, the agency responsible for HIPAA enforcement, announced the formation of three new divisions within the Office for Civil Rights...


EU Data Act Series (part 3): medical and health devices and data sharing obligations

The Data Act Proposal envisages the rights of users of medical devices / health wearables to have access to and to share the data originated from the use of the device with third parties....


Recent developments in African data protection laws – Outlook for 2023

Africa is continuing to strengthen its data protection legal and regulatory framework. To date, thirty six out of fifty four African countries have data protection laws and/or regulations....

Loading data