Tag Archives: Digital Health

OCR Clarifies Direct Liability of Business Associates Under HIPAA

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a new fact sheet outlining and clarifying violations of HIPAA (Health Insurance Portability and Accountability Act of 1996) for which a business associate can be held directly liable. Published shortly after the release of new guidance from OCR in the form … Continue Reading

Is Your Software a Medical Device? FDA Weighs-in with New Draft Guidances

On December 8, 2017 – nearly a year after President Obama signed into law the 21st Century Cures Act (“Cures Act”) – the Food and Drug Administration (“FDA”) released two new draft guidances that aim to implement section 3060 of the Cures Act, and provide clarity on the Agency’s regulatory approach to software as a … Continue Reading
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