On October 11, the National Institutes of Health (“NIH”) issued a request for information (“RFI”), which proposes sample language regarding the use of digital health technologies in research for inclusion in informed consent documents and requests public feedback on the utility and usability of the proposed language. Comments on the RFI are due by December 12, 2023.Continue Reading NIH Requests Information on Developing Consent Language for Research Using Digital Health Technologies

On August 19, 2023, the World Health Organization (“WHO”) announced a new initiative to operationalize the implementation of the Global Strategy on Digital Health 2020-2025 and to further enable digital health system transformation. The Global Initiative on Digital Health (“GIDH”) is a WHO managed network of stakeholders organized to facilitate the implementation of WHO norms and standards for digital health system transformation and to enable a global ecosystem to promote country capacity and strengthen international cooperation in digital health. The GIDH aims to amplify recent and past gains in global digital health while strengthening mutual accountability to enhance the impact of future investments.Continue Reading WHO Announces Global Initiative Focused on Digital Health

On April 4, The Coalition for Health AI (“CHAI”) released the “Blueprint for Trustworthy AI Implementation Guidance and Assurance for Healthcare,” (“CHAI Blueprint”) which addresses the lack of industry-accepted standard governing the development and implementation of artificial intelligence (“AI”) tools in health care, outlines key elements to establish standards on trustworthy AI, issues recommendations for health systems to deploy AI tools in clinical settings, and proposes specifications to be included in a potential assurance standards guide.Continue Reading Coalition for Health AI Introduces Blueprint for Trustworthy AI in Healthcare

Rapid developments and competition in artificial intelligence (AI) will drive proliferation of new AI technologies in health care in the coming years, along with a number of legal and ethical issues.

ChatGPT 3.5 created a huge splash, rife with controversy, when it was released in November 2022. Launched by the San Francisco-based startup OpenAI, ChatGPT is a natural language processing (NLP) model (a type of machine learning (ML)), that automatically learns and recognizes patterns. ChatGPT uses a neural network architecture to generate human-sounding responses to questions, providing users with large amounts of potentially useful information in seconds. According to a recent review, ChatGPT demonstrated that it was capable of passing all three parts of the U.S. Medical Licensing Exam (USMLE), which tests medical students on topics including the basic sciences, clinical knowledge and patient treatment and diagnosis, without any specialized training. ChatGPT also showed proficiency in medical charting, diagnosing, and performing nonclinical tasks. OpenAI recently launched ChatGPT 4.0, which offers expanded capabilities and improved performance on various professional and academic assessments.Continue Reading AI in Health Care: AI Bill of Rights, Future Regulations, and What Business Should Consider Now

On January 19, 2022, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published the Trusted Exchange Framework and Common Agreement (TEFCA) for health information exchange. The Trusted Exchange Framework established a set of non-binding, foundational principles for trust policies and practices to help facilitate