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 November 28, Crowell Health Solutions published a white paper outlining several policy recommendations to advance widespread adoption of decentralized clinical trials (DCTs). The white paper titled, “Advancing Adoption of Decentralized Clinical Trials: Rationale, Current State, and Policy Recommendations” examines the current environment on decentralized and hybrid clinical trials, including a discussion on benefits and challenges that DCTs may pose; existing legislation and regulation; and background on programs and policies that can be leveraged to support DCT adoption.Continue Reading Crowell Health Solutions Examines the Adoption of Decentralized Clinical Trials and Provides Policy Recommendations

On October 24, 2023, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) jointly released a publication identifying five guiding principles for predetermined change control plans (“PCCP”) for machine learning-enabled medical devices (“MLMD Guiding Principles”).Continue Reading FDA Releases Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles

On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued final guidance entitled, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring,” (the Final Guidance) to provide clarification on its enforcement policies and premarket review expectations for certain non-invasive remote monitoring devices used for patient monitoring at the conclusion of the COVID-19 public health emergency (PHE). Specifically, the FDA will continue to allow most remote monitoring devices to be used in home settings and to allow certain hardware or software changes to allow for increased remote monitoring capabilities under enforcement discretion.Continue Reading FDA Issues Final Guidance on Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring

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 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 June 21, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed notice with comment period outlining a transitional Medicare coverage pathway for emerging technologies through the national coverage determination (“NCD”) process in addition to several guidance documents that describe CMS’ approach to coverage reviews and evidence development, including the National Coverage Analysis Evidence Review and Clinical Endpoints Guidance: Knee Osteoarthritis.Continue Reading CMS Proposes Transitional Medicare Coverage Pathway for Emerging Technologies

As we move into 2023, the impact of the pandemic on marginalized groups continue. The COVID 19-pandemic has exacerbated longstanding racial and ethnic disparities in health care. In terms of national healthcare spending, healthcare inequities make up about $230 billion in annual spending; and that amount could potentially reach $1 trillion by the year 2040 if inequities persist or worsen. In 2021, the Centers for Medicare & Medicaid Services (CMS) announced a new strategic vision to guide the Centers’ model testing and priorities toward a vision of achieving equitable outcomes through high-quality, affordable, person-centered care. But it is important to also highlight what other federal agencies, states, and health plans are doing to address health inequity especially as our healthcare system, as a whole, is moving towards value-based care initiatives.Continue Reading Health Sector Efforts to Address Health Equity and Affordability in 2023