Digital Health

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On October 18, 2024, the American Medical Association’s (AMA’s) Current Procedural Terminology (CPT) Editorial Panel released a Summary of Panel Actions from its September 2024 Panel Meeting, which includes six new remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) codes in addition to revisions to the existing codes. Effective January 2026, these changes include removing the current requirement for healthcare providers to receive 16 days’ worth of data to bill RPM codes. The AMA CPT Editorial Panel likely made these updates in response to stakeholder feedback that the 16-day billing threshold was not necessary in certain clinical use cases. Additionally, two new codes will reimburse providers for 10-19 minutes of managing RPM or RTM data in a month.  Continue Reading AMA’s CPT Editorial Panel Approves New Codes Covering Remote Patient Monitoring Services

On April 18, 2024, the Department of Health and Human Services’ (HHS’) Agency for Healthcare Research and Quality (AHRQ) issued the Digital Healthcare Equity Framework (the Framework) to guide users and stakeholders to consider equity throughout the entire lifecycle when implementing digital healthcare solutions. AHRQ also released a separate implementation guide (the Guide) to outline best practices and examples to implement the Framework. The Framework’s guiding principles provide a clear purpose for the Framework and development of its domains while the separate Guide provides actionable steps on how to implement the Framework.

Digital healthcare developers and vendors, health systems, health plans, and clinical providers should review the Framework and Guide to assess equity during each phase of the digital healthcare lifecycle for digital health technologies. Specifically, the Framework recommends that these stakeholders should consider the Framework’s principles and recommendations to address the accessibility, purpose, security, privacy features, usability, and safety concerns applying to digital solutions.Continue Reading AHRQ Outlines Principles and Recommendations to Advance Digital Healthcare Equity

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

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