One well-recognized way to protect patient privacy is to de-identify health data.  However, trends around increases in publicly-available personal data, data linking and aggregation, big data analytics, and computing power are challenging traditional de-identification models.  While traditional de-identification techniques may mitigate privacy risk, the possibility remains that such data may be coupled with other information to reveal the identity of the individual. Last month, a JAMA article demonstrated that an artificial intelligence algorithm could re-identify…

On February 15, 2019, the U.S. Food and Drug Administration (“FDA”) finalized two guidance documents regarding regenerative medicine therapies (see FDA’s announcement here). This development comes nearly 14 months after FDA issued both guidance documents in draft form, which also coincided with FDA’s announcement of a new comprehensive regenerative medicine policy framework intended to spur innovation and efficient access to new regenerative medicine products. FDA Commissioner Scott Gottlieb remarked that the finalization of regenerative…

On February 11th, blockchain advocates, digital health enthusiasts, and patients received positive news from the Center for Medicare and Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”) regarding patient data sharing.  These rules, taken together, seek to make data more liquid, which can promote patient access, continuity of care, research, collaboration across the industry and several other activities that previously faced challenges within a health care system built…

GenomeDx Biosciences Corp., which markets a genomic test (Decipher®) intended to assess the aggressiveness of prostate cancer, has agreed to pay $1.99 million to the U.S. Department of Justice to resolve allegations that it violated the False Claims Act (31 U.S.C. §§ 3729 et seq.)(“FCA”) by submitting claims to Medicare for tests conducted to evaluate treatment options for men after prostate surgery. The government and a whistleblower alleged that between September 2015 and June 2017, GenomeDx…

Gummies, brownies, sodas, cookies . . . consumer appetite for food and dietary supplement products containing cannabidiol (“CBD”) has grown over the last few years as states have moved to legalize cannabis for medical or limited recreational use.  With the passage of the 2018 Farm Bill on December 20, 2018, which legalized the cultivation of hemp for certain purposes, the “edibles” industry appeared poised for further expansion. However, recent developments at both the federal and…

There is a new kid on the block . . . the Chief Data Officer (CDO).  There is no surprise in our data-driven world that such a role would exist. Yet, many organizations struggle with defining the role and value of the CDO. Effective implementation of a CDO may be informed by other historical evolutions in the C-Suite. Examining the rise of the Chief Compliance Officer (CCO) in the 2000’s mirrors some of the same…

For the first time since 2008, the Advanced Medical Technology Association (“AdvaMed”) has updated its “Code of Ethics on Interactions with Health Care Professionals.”  These updates were announced on January 9, 2019 and will become effective on January 1, 2020. AdvaMed’s goal in updating the Code was to address the evolving nature of interactions between the medical device industry and health care professionals (“HCPs”), bring existing examples up-to-date, and enhance user-friendliness.  Topics that were previously…