Health IT policy and standards: What you need to know right now
Electronic health information, telehealth, interoperability and medical devices are elevated prominently in emerging policy and standards updates affecting Health IT policy for hospitals and health systems across the country.
Here’s a recap of some recent developments to monitor in the coming weeks and months.
Electronic health information and designated record set compliance policy
The American Health Information Management Association, American Medical Informatics Association and Electronic Health Record Association have released its final report related to operationalizing the definitions of electronic health information (EHI) and designated record set (DRS). The resource is intended to help healthcare providers, health IT systems, health information exchanges and health information networks in their efforts to comply with the information blocking provisions of the Cures Act Final Rule, which was published in the Federal Register on May 1, 2020. Beginning Oct. 6, 2022, all will be expected to adhere to the full scope of EHI for purposes of information blocking compliance.
Hospital inpatient services modernization act
When hospitals were overloaded with patients at the height of the COVID-19 pandemic, CMS launched the Acute Hospital Care at Home (AHCH) waiver program, which allows Medicare beneficiaries to receive acute-level healthcare services within their home.
The waiver is set to expire at the end of the federal COVID-19 Public Health Emergency. Bipartisan legislation (H.R. 7053/S. 3792), introduced in March by Reps. Brad Wenstrup (R-OH) and Earl Blumenauer (D-OR) in the House and Sens. Tom Carper (D-DE) and Tim Scott (R-SC) in the Senate would extend the waiver program for two years beyond the duration of the PHE. Additionally, if signed into law, the act would require the HHS Secretary to issue regulations within 12 months establishing health and safety requirements for Acute Hospital Care at Home programs. HHS would also submit to Congress an evaluation report based on data collected by CMS related to the quality of care provided under AHCH waivers, as well as patient outcomes, beneficiary access, health disparities, patient safety, cost and utilization.
NIST cybersecurity resource guide, public policy comment still open
The National Institute of Standards and Technology (NIST) has released the initial draft of its resource guide for implementing the HIPAA Security Act. Last updated in 2008, the newly revised version includes guidance on maintaining the confidentiality, integrity and availability of electronic protected health information (ePHI). The document focuses on protecting ePHI created, received, maintained or transmitted by regulated entities of all sizes. NIST will accept public comments on the draft until Sept. 21, 2022.
Related story: What you need to know about the NIST privacy framework
Interoperability standards policy proposal still open for public comment
The 9th Annual Interoperability Standards Advisory (ISA) Reference Edition will be published in January 2023. The Office of the National Coordinator for Health Information Technology (ONC), with input from public comments, curates the ISA catalog of standards and implementation specifications. ONC reports that public comments “figured prominently” in last year’s ISA update, with new information added in the areas of pharmacy interoperability, public health reporting, social determinants of health and health equity. You can submit comments on the ISA 9th Edition. The open comment period runs until Sept. 30, 2022.
HHS-OIG telehealth webpage
In July, the Health and Human Services Office of Inspector General (HHS-OIG) launched a centralized information page related to oversight of telehealth services. With the sharp increase in telehealth services during the pandemic covered by federal healthcare programs, enforcement activity is expected to increase. HHS-OIG auditing of telehealth services and enforcement actions will be reported on the new webpage.
EMDR system enhancements policy from the FDA
The FDA’s Center for Devices and Radiological Health (CDRH) oversees regulatory pathways for medical devices and radiation-emitting products. In June, the FDA announced enhancements to CDRH’s Electronic Medical Device Reporting (eMDR) system, including reporting changes for device manufacturers. CDRH plans to release an implementation package and test its Electronic Submissions Gateway in late summer with live deployment scheduled for March 2023. The FDA expects to follow a similar cycle for eMDR changes in the following years. Manufacturers on CDRH’s email list will receive regular communications regarding the process.
Frank Irving is a Philadelphia-based content writer and communications consultant specializing in healthcare, technology and sports.