New information blocking regulation goes into effect April 5, 2021

October 29, 2020

Earlier this year, CMS and the Office of the National Coordinator for Health Information Technology (ONC) established new information blocking regulations to better monitor how providers share health data. The new rules take effect beginning April 5, 2021 and primarily apply to Certified Electronic Health Record Technology (CEHRT) but not laboratory information systems (LISs). However, pathologists and labs are required to provide certain info to their organization’s CEHRT.

Initially, the rules were set to take effect Nov. 2, 2020, before provider pushback caused CMS to delay implementation until April 5, 2021.

Currently, many EHR contracts contain provisions that either prevent or are perceived to prevent users from sharing information related to the EHRs in use, such as screen shots or video. The ONC final rule updates certification requirements for health IT developers and establishes new provisions to ensure that providers using CEHRT have the ability to communicate about health IT usability, user experience, interoperability, and security including (with limitations) screenshots and video, which are critical forms of visual communication for such issues.

Although performing labs are required to report results to the ordering provider or lab, the final regulation does not specifically outline what info must be provided. In the absence of that guidance, this means that decision will be determined by a pathologist in conjunction with their organization. While important data stewardship issues may exist with patient portals and modules, there are not direct regulatory or accreditation issues for the performing lab.

In most instances, the laboratory would not require additional reporting other than the required info that it has agreed to provide to its clients. Reporting to the ordering physician with reasonable turnaround time should satisfy the law.

For most cases, patient health data will be reported to the certified HER and then on to the patient through a portal like MyChart. The provider organization decides what to report through that mechanism in consultation with its medical staff. A similar situation would exist where a laboratory does outreach work and reports back to the office EHR. That report should satisfy information-sharing requirements, and the responsibility for reporting directly to patients should rest with the EHR. In cases where laboratories support direct patient testing without a report to an EHR or physician, there would be a need to maintain a mechanism for reporting to the patient, but that need already exists apart from the 21st Century Cures Act final regulation.

However, there are also complex situations in which ONC will consider certain exceptions to information blocking that would warrant blocking the release of information. The full list of those exceptions and their descriptions may be accessed here: https://www.healthit.gov/cures/sites/default/files/cures/2020-03/InformationBlockingExceptions.pdf

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