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On December 20, 2023, the National Institute of Standards and Technology (“NIST”) National Cybersecurity Center of Excellence (“NCCoE”) published its Cybersecurity of Genomic Data report (the “Report”).  The Report aims to assist organizations in protecting against misuse of genomic data and enabling secure collaborative innovations.  Note, however, that the Report is not authoritative with respect to its assessment of the treatment of genomic data under the current U.S. regulatory framework, including with respect to the identifiability of such information.Continue Reading NIST Cybersecurity Center of Excellence – Cybersecurity of Genomic Data Report 

The past year has seen unprecedented growth and development of artificial intelligence (“AI”) tools, which have been significantly propelled by the rapid deployment of generative AI (“GenAI”) tools.  The health care and life sciences industries have increasingly sought the use of AI and GenAI tools to promote innovation, efficiency and precision in the delivery of treatment and care, as well as in the production of biologics and medical devices.  For example, AI tools may more accurately predict and analyze diagnostic test results and develop personalized treatments than traditional tools; may improve clinical trial design, eligibility screening and data analysis; may be used as a diagnostic tool in a clinical trial designed to assess the safety or efficacy of a medical device; and may be used to accelerate the drug development timeline.  While such uses raise inherent concerns regarding, among other things, the improper use and/or disclosure of personal information, the introduction and/or perpetuation of bias and discrimination, as well as data security, reliability, transparency and accuracy, there is currently no developed federal or cohesive state regulatory framework designed to minimize such risks.  Continue Reading The 2023 AI Boom Calls for Further Regulation of the Use of AI Tools in the Health Care and Life Sciences Industries

Law360 (October 4, 2021, 5:30 PM EDT) —
On June 29, Florida Gov. Ron DeSantis signed into law H.B. 833, known as the Protecting DNA Privacy Act.

The act took effect on Oct. 1, and applies to the collection, use, retention, maintenance and disclosure of a DNA sample collected from an individual in Florida as well as the results of any subsequent DNA analysis. The act is self-executing and took effect without the need for creation of implementing regulations.

The act clarifies the extent to which individuals own their genetic information, and it creates new crimes for the unlawful collection, retention, analysis, disclosure or sale of an individual’s DNA sample and the results of a DNA analysis, subject to certain limited exemptions, such as use for specified clinical or research purposes.

The act also has important implications for secondary uses of data by health care providers and others that perform genetic testing and analyze genetic information.Continue Reading What Florida’s DNA Privacy Law Means For Health Care Providers

BillOn March 19, 2020, Governor Pritzker issued Executive Order 2020-09 (the “Executive Order”), expanding access to health care services for all Illinois residents provided through remote means during the term of the COVID-19 Gubernatorial Disaster Proclamation, which declares a state of disaster in Illinois. The Executive Order expands the technologies that may be used to deliver telehealth services and creates a coverage requirement for all medically necessary services delivered through telehealth. The Executive Order is followed by the recent CARES Act, which expands access to telehealth for Medicare beneficiaries, and the filing of an 1135 Waiver under the Social Security Act by the Illinois Department of Health and Family Services (“IDHS”) to expand its already broad Medicaid coverage of telehealth services.
Continue Reading Illinois’s Expansion of Access to Health Care via Telehealth Executive Order 2020-09 & Medicaid Emergency Rulemaking