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Australia: New SOCI Critical Infrastructure Risk Management Program Rules now in effect

The Security of Critical Infrastructure (Critical Infrastructure Risk Management Program Rules) (LIN 23/006) 2023 (CIRMP Rules) came into force on 17 February 2023. Responsible entities for ...


Global Payments Newsletter, February/March 2023

Key developments of interest over the last two months include: the Central Bank of Ireland publishing a Dear CEO letter to the payments industry; the Bank of England and HM Treasury...


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...


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,...

Insights and Analysis

U.S. FDA regulatory insights: the seemingly shifting landscape of clinical decision support
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Clinical decision support (CDS) software has lately been a focus of discussion between FDA, industry, and other interested parties. CDS tools assist clinicians by analyzing patient data and ...


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....


MEDCAC Coverage with Evidence Development meeting offers CMS guidance on CED study requirements

On February 13-14, 2023, the Centers for Medicare & Medicaid Services (CMS) convened a virtual panel of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to...

Hogan Lovells Podcasts

Podcast: Talking the cure

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting-edge topics such as...

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