The 21st Century Cures Act, which Congress passed late last year, includes a section that bars “information blocking” by technology vendors or healthcare providers.
Now, a diverse coalition of groups, spearheaded by Health IT Now, has asked the Department of Health and Human Services (HHS) to issue a proposed rule that would further define information blocking and stipulate how the law will be applied. Presumably, this would be part of the proposed rule for the 21st Century Cures Act, which has not yet been released.
In a letter sent on Tuesday to Donald Rucker, MD, national coordinator of health IT, and Daniel Levinson, inspector general of HHS, Health IT Now and a dozen other organizations mostly representing healthcare providers, patients, and employers said they strongly supported the goals of the anti–information-blocking legislation. However, they advocated a “nuanced approach” and suggested that HHS “gain broad stakeholder input” before implementing the information-blocking provision.
The most important questions, according to the Health IT Now coalition, are these:
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What is information blocking and what is not?
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What constitutes “special effort” in eliminating blocking and promoting interoperability?
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How ought “should have known” be defined?
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How should patient access [to information] be measured?
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How does the law interact with existing laws like the Health Insurance Portability and Accountability Act and medical malpractice?
The second bullet point refers to language requiring that health IT systems be designed to enable the secure exchange of information “without special effort on the part of the user.”
The third bullet point refers to a clause that says a health IT developer, exchange or network could violate the law if it knows “or should know” that a particular practice “is likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information.”
The letter also asks another dozen questions related to various aspects of the information-blocking section. Among other things, the inquiries concern the possibilities of establishing “safe harbors” and “a mitigation pathway before claims are subjected to OIG [Office of Inspector General] investigation and penalties.”
$1 Million per Violation
Following in the footsteps of a report by the Office of the National Coordinator for Health Information Technology (ONC), the 21st Century Cures Act prohibits information blocking by providers and technology vendors. However, it is “developers, networks and exchanges” that, if found guilty of these practices, would be fined up to $1 million per violation. Electronic health record (EHR) vendors could also be decertified, leading to a loss of customers. No specific penalties are mentioned for providers that obstruct information flow.
Among the signatories of the Health IT Now letter, the only EHR vendor is athenahealth (also a member of Health IT Now). Sasha TerMaat, chair of the Healthcare Information and Management Systems Society EHR Association and a director of Epic, told Medscape Medical News, “We agree that ONC and the HHS OIG should clarify key terms and concepts in their forthcoming proposed rules relative to information blocking. We have communicated our perspectives to HHS to assist them in development of these proposed regulations.”
Among the organizations that signed the letter are the American Academy of Family Physicians, the American Academy of Ophthalmology, the American Medical Informatics Association, athenahealth, DirectTrust, Health IT Now, the Healthcare Leadership Council, IBM, ION Solutions, McKesson, the National MS Society, the National Partnership for Women & Families, and Oracle.
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