21st Century Cures Act

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Interoperability-MEME

As consumerism in healthcare increases, companies and the individuals they serve are increasingly sharing data with third-party application developers that provide innovative ways to manage health and wellness, among numerous other products that leverage individuals’ identifiable health data.  As the third-party application space continues to expand and data sharing becomes more prevalent, it is critical that such data sharing is done in a responsible manner and in accordance with applicable privacy and security standards. Yet, complying with applicable standards requires striking the right balance between rules promoting interoperability vis-à-vis prohibiting information blocking vs. ensuring patient privacy is protected. This is especially difficult when data is sent to third party applications that remain largely unregulated from a privacy and security perspective.  Navigating this policy ‘tug of war’ will be critical for organizations to comply with the rules, but also maintain consumer confidence.
Continue Reading Be Aware Before You Share: Vetting Third Party Apps Prior to Data Transfer

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Eighty years ago today, President Roosevelt signed the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).  In recognition of this anniversary, EBG reviews how the FD&C Act came to be, how it has evolved, and how the Food and Drug Administration (“FDA”) is enforcing its authority under the FD&C Act to address the demands of…

The 21st Century Cures Act (“Cures Act”) was enacted in December of 2016.  Among other things, the Cures Act includes provisions to encourage the interoperability of electronic health records. Specifically, the Cures Act provides for civil penalties for those who engage in “information blocking.”  The Cures Act defines “information blocking” broadly as a “practice…

Recent federal and state legislative efforts signal an increased focus on a significant and largely underappreciated public health threat – antimicrobial resistance (i.e., when a microorganism (such as a bacteria or virus) is able to resist the effects of medications such as antibiotics and antivirals, causing such medications to be ineffective). The results of a…

Last week, the U.S. Department of Health and Human Services (“HHS”) announced that FDA intends to update its regulations governing clinical studies of new drugs.  More specifically, FDA intends to update Parts 312 and 16 of Title 21 of the Code of Federal Regulations (the “Code” or “CFR”).  In its announcement, HHS stated that the…