Seven major healthcare industry groups are calling for federal policymakers to make major changes to proposed data blocking regulations, including delaying the publication of a final rule.
Given the seismic shift for the healthcare industry associated with the data blocking regulation, seven provider groups are calling for the Office of the National Coordinator for Health IT (ONC) to instead issue a supplemental notice of rule-making and to clarify the language in the rules.
During a hearing of the Health IT Advisory Committee (HITAC) Tuesday, College of Healthcare Information Management Executives (CHIME) Vice President of Federal Affairs Mari Savickis urged ONC to allow additional time to address the myriad questions raised by various stakeholders around the data blocking proposals.
There continues to be confusion around ONC's definition and scope of electronic health information and health information networks, she said.
Savickis spoke on behalf of CHIME as well as the American Medical Association, the American Health Information Management Association, the Federation of American Hospitals, the Medical Group Medical Association, the American Medical Informatics Association and the Premier Healthcare Alliance.
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HITAC was created in the 21st Century Cures Act and recommends policies and standards to ONC.
ONC released its proposed information blocking rule (PDF) back in February that defines seven exceptions to data blocking and fines that may be associated with the practice, and was mandated by the 21st Century Cures Act. The rule also provides standardized criteria for application programming interface (API) development and calls for the adoption of standardized APIs within two years after the rules are completed.
The Centers for Medicare & Medicaid Services (CMS) also issued a proposed interoperability rule (PDF) that requires insurers participating in CMS-run programs like Medicare, Medicaid and the federal Affordable Care Act exchanges by Jan. 1 to have the capability to give 125 million patients electronic access to their personal health information at no cost to patients.
Many organizations have voiced strong criticism of the proposed rules for being too burdensome and costly. ONC’s proposed definition of electronic health information is unnecessarily and overly broad and would be administratively complex to meet, many stakeholders said. The Health Innovation Alliance, formerly Health IT Now, even called for the rules from ONC to be scrapped entirely and rewritten.
The groups outlined five recommendations for ONC to help make the proposed interoperability rules less burdensome for providers and vendors.
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Along with delaying implementation of the information blocking rule, the groups recommend ONC and CMS stagger the rule deadlines. The proposed implementation timelines under the information rule combined with deadlines set by CMS for its Promoting Interoperability initiative and other policies will result in overlapping deadlines. This creates layers of complex requirements for both providers and vendors, Savickis said.
The information blocking rule will require electronic health records and other health IT vendors to make substantial changes to their products, so the groups urge ONC to create a new version of its health IT certification rather than updating the 2015 certification. Creating an entirely new version of the certification will help reduce confusion and enhance implementation, she said.
Under ONC's proposed rule, stakeholders that violate the prohibition against data blocking could be penalized $1 million per instance of information blocking.
The groups are calling for ONC to soften the rule enforcement as well. "Given the substantial industry shift associated with this rulemaking and given the confusion regarding the definitions contained in the rule, including exceptions to the information blocking rule, we believe a more fruitful approach would be one that centers around education and opportunities for corrective action," Savickis said.
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The groups would like to see ONC implement a period of enforcement flexibility to allow actors to absorb lessons learned and address specific issues rather than take a punitive approach.
ONC also needs to beef up its focus on data privacy and security in the proposed rules, the groups said. "The rule doesn’t sufficiently address the 21st Century Cures directive to protect patient data privacy and health IT security which could potentially exacerbate these issues going forward," she said.
Savickis urged HITAC members to address security and privacy concerns for data sharing that fall outside of the HIPAA privacy rules.