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Manufacturers Health Insurance Portability and Accountability Act (HIPAA) Compliance

Gardner Law

Navigating HIPAA and State Privacy Laws for Drug and Device Manufacturers

Gardner Law on

The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

Ankura

eDiscovery and Life Sciences Industry - Challenges and Solutions

Ankura on

The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Sheppard Mullin Richter & Hampton LLP

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information...more

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