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Clinical Research and Data: HIPAA, the Common Rule, the General Data Protection Regulation, and Data Repositories

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Clinical Research and Data: HIPAA, the Common Rule, the General Data Protection Regulation, and Data Repositories

October 7, 2018

Clinical Research and Data: HIPAA, the Common Rule, the General Data Protection Regulation, and Data Repositories

The inexorable march of Moore’s Law has resulted in changes in all areas of our lives, including how we do clinical research. Researchers and patients are more connected. We store, access, and manipulate data in different ways; we conduct studies in multiple countries sharing data and samples around the world; and cybersecurity and hacking are a reality. This article touches on different legal aspects arising at the intersection of technology, data, and clinical research— specifically HIPAA (the Health Insurance Portability and Accountability Act), human subjects research, the European data law (the General Data Protection Regulation), and data repositories. It attempts to explain how two different law-making bodies, the US and the EU, have tried to balance the necessity of using data for research purposes that benefit society with the privacy issues and risks of that same data.

The full article can be downloaded below.  

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