Stefanie Linares Hood participated in a panel discussion on the legal and regulatory framework for data privacy in clinical studies at the National Association of Minority and Women Owned Law Firms (NAMWOLF) Driving Diversity & Leadership Conference in San Antonio.
Download Hood’s PowerPoint presentation here:
What is NAMWOLF?
The mission of NAMWOLF is to promote diversity in the legal profession by fostering successful relationships among preeminent minority and women owned law firms and private/public entities.
The Conference provided Edwards, Maxson, Mago & Macaulay, LLP an opportunity to present a Continuing Legal Education (CLE) for attendees. During the CLE entitled, “Whose Data is it Anyway?”, Stefanie discussed the 21st Century Cures Act and how to develop plans to implement interoperability requirements and avoid information blocking.
The program examined data compliance strategies, state law compliance and preemption, and related business risk issues.
What is Information Blocking?
The 21st Century Cures Act was signed into law on December 13, 2016. It contains provisions focused on advancing interoperability and preventing information blocking.
Information blocking is a practice by a healthcare provider, health IT developer, health information network or health information exchange that is likely to interfere with access, exchange, or use of electronic health information (EHI).
Application of the rule began April 5, 2021. The CLE covered practices that constitute information blocking and identified the exceptions defined by the Office of the National Coordinator for Health Information Technology (ONC).
The ONC’s Cures Act Final Rule established the United States Core Data for Interoperability (USCDI) standard, which sets forth data classes and elements that support nationwide interoperability.
Impact of the panel discussion
Stefanie discussed the interoperability between electronic health record systems and the benefits to patients and researchers.
The Cures Act puts the patient in control of their health care by providing secure and easy access to electronic health records. It promotes innovation and encourages transparency. This benefits researchers by eliminating barriers to health information and allowing patients to directly participate in clinical studies.
For more information, please check out Hood’s PowerPoint presentation here: