Health Information Compliance Alert

Enforcement News:

HHS Final Rule for Certified Health IT Defines Limits with Broad CMS Changes Ahead

Clarity, accuracy, and safety are at the core of technical guidelines to protect public health.

As CMS moves Meaningful Use (MU) to the side and puts Advancing Care Information (ACI) front and center, HHS aims to set up federal guidelines for certified health IT with its final rule titled the “ONC Health IT Certification Program: Enhanced Oversight and Accountability.”

“More transparency and accountability in health IT is good for consumers, physicians, and hospitals,” said Vindell Washington MD, MHCM, national coordinator for health IT in an Oct. 14, 2016 HHS news release. “Today’s final rule strengthens the program by ensuring that certified health IT helps clinicians and individuals use and exchange electronic health information safely and reliably.”

What’s at stake. The three top ideas from the final rule focus on making EHRs and the vendors who provide them more accountable to federal standards. HHS hopes that this program allows providers and hospitals to better coordinate care, strengthen patient relations, and benefit from the latest innovations with the knowledge that their health IT products are safe and secure.

Here’s a short breakdown of the three basic initiatives:

  • “Direct review” is the “framework” that the ONC will follow when assessing and managing the risks, challenges, and corrective measures for new CEHRT and products under its program.
  • The final rule hopes that with “consistent authorization and oversight” that testing, performance, and any other important implementation issues between the ONC and its subsidiaries — the ONC-Authorized Certification Bodies (ONC-ACBs) and ONC-Accredited Testing Laboratories (ONC-ATLs) — remains smooth and efficient.
  • The certification program sees the need for “increased transparency and accountability” on the part of the vendors, so the ONC can assist health IT customers in identifying the safest products for their practices.

For a thorough reading of the HHS news release as well as a link to the Federal Register’s final rule, visit http://www.hhs.gov/about/news/2016/10/14/hhs-issues-final-rule-enhance-reliability-transparency-accountability-and-safety-certified-health.html.