In recent years, organizations have been developing and using predictive models, which are powered by artificial intelligence (AI) and machine learning (ML) technologies, for numerous use cases in clinical and health care settings, including to aid in clinical decision-making. Currently, healthcare AI systems and tools have both clinical and administrative applications, namely monitoring patients, recommending treatments, predicting health trajectories, recording clinical notes, optimizing operational processes, and supporting population health management.

The Department of Health and Human Services (HHS) and federal agencies have been developing policies to advance transparency and manage risks for the development and use of AI/ML-powered health care technologies. Most recently, the Office of the National Coordinator for Health Information Technology (ONC) issued regulations that addresses predictive models and health AI systems.Continue Reading Taking a Closer Look at ONC’s AI Transparency Regulations

On February 21, Senator Bill Cassidy (R-LA), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report to propose policy recommendations to revise the Health Insurance Portability and Accountability Act of 1996 (HIPAA) framework and ensure privacy protections for health data and information. In the report, Senator Cassidy highlights recent reports of breaches and violations of patients’ health data privacy and outlines several proposals to modernize the HIPAA framework and other privacy regulations.Continue Reading Senate HELP Committee Ranking Member Issues Health Data Privacy Policy Recommendations

The Office of the National Coordinator for Health Information Technology (ONC) released a draft of their 2024–2030 Federal Health IT Strategic Plan (Draft Strategic Plan) on March 27, 2024, updating the 2020-2025 Federal Health IT Strategic Plan. In collaboration with 25 other federal organizations, the purpose of this strategic Plan is to create overall improvements in health care by aligning its health IT policies, programs, and investments and to signal priorities to the industry. This Draft Strategic Plan builds on the previous Plan, and includes objectives to address challenges in our healthcare landscape post-COVID as well as recognizing current disparities in health care access and outcomes.Continue Reading ONC Releases an Updated Draft of Their 2024–2030 Federal Health IT Strategic Plan

On February 8, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a quality standard memorandum (Memorandum) clarifying that hospitals and critical access hospitals (CAHs) may transmit patient information and orders via text message under certain conditions. Although Computerized Provider Order Entry (CPOE) continues to be the preferred method of order entry, healthcare team members are permitted to share patient information and orders among themselves through a Health Insurance Portability and Accountability Act of 1996 (HIPAA)-compliant secure texting platform (STP) in accordance with Medicare and Medicaid Conditions of Participation (CoPs). The Memorandum reverses CMS’s position in a January 2018 memorandum and is effective immediately.Continue Reading CMS Issues Guidance on HIPAA-Compliant Secure Texting Platforms

The ever-changing healthcare policy landscape will witness at the federal level regulatory changes driven by the need to transform healthcare delivery, quality and innovation. Looking forward in 2024, this summary examines a number of healthcare innovation topics that have seen significant policy activity in recent years and that are relevant to healthcare stakeholders, including providers, plans, electronic health record (EHR) vendors and health technology companies.

Stakeholders should use this summary to examine existing regulatory and compliance gaps, prepare their organizations to comply with forthcoming federal regulations, and keep apprised of federal funding opportunities. For more information on these policy developments, please contact the professionals listed below, or your regular Crowell contact.Continue Reading Healthcare Policy Developments to Watch in 2024

On December 22, 2023, FDA issued final guidance–Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. This final guidance is aimed at sponsors and others who may be involved in remote data acquisition for clinical trials to evaluate medical products. As digital health technologies (DHTs) used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research the FDA is providing guidance for ensuring that technologies used are safe, appropriate, and store and transmit data appropriately. Highlights of the guidance are below.Continue Reading FDA Releases Guidance on Digital Health Technologies for Clinical Investigations  

On August 18, 2023, the World Bank issued a publication entitled, “Digital-in-Health: Unlocking the Value for Everyone (“World Bank Report”),” which recommends to governments a new digital-in-health approach where digital technology and data are infused into every aspect of health systems management and health service delivery to improve individuals’ health outcomes. The stated goal of the World Bank Report is to provide governments and other stakeholders with practical guidance on how to build digital health infrastructure, regardless of a country’s digital maturity or fiscal challenges.Continue Reading World Bank Issues Digital Health Recommendations in Report

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