Whither Interoperability? The 21st Century Cures Act

Tucked into the FDA innovations of the 21st Century Cures Act recently passed by the House of Representatives and sent over to the Senate is a subtitle on interoperability. (Link goes to bill summary and status page. See Title II – Delivery, Subtitle A – Interoperability, pp. 244-298 of the PDF of the bill as sent from the House to the Senate. H.R. 6, 21st Century Cures Act.) Your faithful HealthBlawger will highlight some interesting points; it is worth reading the whole subtitle.

ONC issued a draft ten-year interoperability roadmap earlier this year. While it represents a thoughtful plan for getting from here to there, not everyone is content to wait ten years; in fact, some of us believe that we should be looking ahead, beyond interoperability. At the direction of Congress, ONC issued a report on information blocking practices in the EHR vendor community. Congress is now focused on refining the definition of interoperability and fleshing out the regulatory space around interoperability, so that we get there sooner, and so that there are consequences for those who don’t play nice.

As is often the case in turgid legislative prose, the bill’s authors buried the lede: Please start reading on pp. 296-298, in the section titled “Patient Engagement and Empowerment” (Sec. 3010A(h)):

It is the sense of Congress that
(1) if the strategic goals that Congress set forth in the HITECH Act are to be achieved, interoperability is best achieved with individuals and authorized representatives having equal access to the health information of such individuals in electronic format;
(2) patients have the right to the entirety of the health information of such individuals, including such information contained in an electronic health record of such individuals;
(3) such right extends to both structured and unstructured data; [and]
(4) such right extends to authorized representatives of the individual involved, such as caretakers of such individual, family members of such individual, and guardians of such individual[.]

In order to address this “sense of Congress” the bill tackles a redefinition of interoperability, in Section 3010:

‘‘(a) INTEROPERABILITY.—In order for health information technology to be considered interoperable, such technology must satisfy the following criteria:

‘‘(1) SECURE TRANSFER.—The technology allows the secure transfer of all electronically accessible health information to and from any and all health information technology for authorized use under applicable State or Federal law.

‘‘(2) COMPLETE ACCESS TO HEALTH INFORMATION.—The technology allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law without special effort by the requestor of such health information.

‘‘(3) NO INFORMATION BLOCKING.—The technology is not configured, set up, or implemented to information block, as defined in section 3010A(d).

The definition of information blocking is more extensive – follow the link to read it in full. The core of the definition is as follows: With respect to access, use and exchange of EHRs and other HIT, business, technical and organizational practices that the person behind the practices knows or should know prevent or materially discourage the access, exchange or use of electronic health information. Examples include business terms and practices that restrict authorized uses of data; unreasonable prices for exchange, portability, interfaces; nonstandard architecture that is likely to make interoperability more expensive; and developing HIT in a way that is likely to lead to lock-in of users, lead to waste, fraud or abuse, or impede innovation.

In its report to Congress, ONC used the phrase “knowingly and unreasonably” to define information blocking. The bill retains the four categories of examples of prohibited practices, but broadens the “intent” element to “known or should have known.”

At the core of the bill’s definition of interoperability: “Complete access . . . without special effort.” Sounds like a dream, right? Well, the bill’s authors would like to see this become reality by 2018. For all certifications of EHRs on or after January 1, 2018, the standards laid out in the bill, and to be fleshed out in regulation, must be satisfied.

The bill abolishes the Health IT Standards Committee and proposes to have the work of developing interoperability standards contracted out though usual procurement channels, and reviewed and approved by NIST and the Secretary of HHS in addition to ONC. It also requires attestations by EHR vendors as to their products’ compliance with the interoperability standard, and it calls for the creation of a federal website that will have full transparent pricing for every certified EHR (and its components and interfaces) — as an aside, wouldn’t it be nice if the federales had that sort of pricing transparency approach for all patients and all health care expenses? — and for the provision of full copies of health records to patients at no charge.

The bill describes a process for imposition of civil monetary penalties and decertification of EHRs if they do not meet, or continue to meet, interoperability standards. Providers using decertified EHRs will be given at least a year to transition to a new EHR.

Overall, this looks like a step in the right direction, though I am sure many will find fault with parts of the bill. For example, patient advocates may wonder why standards development is being wrested from an advisory committee and handed over to one or more government contractors, or why there is a potentially huge exception being made to the definition of impermissible information blocking — as in: it’s OK if it’s needed in order to promote competition. The EHR industry may also wonder about farming out of standards development (is Congress concerned about regulatory capture?) and may generally balk at the way in which Congress is seeking to turn up the heat.

Stay tuned as the Senate, starting with the Senate HELP Committee, tackles this bill.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting