With President Barack Obama’s signature earlier this week, the landmark 21st Century Cures Act was passed into law. The massive 996-page bill covers a wide array of healthcare issues, perhaps most notably focusing on medical research and changing the approval process for new drugs and medical devices.
But the bill also contains a number of provisions directly impacting the healthcare technology industry. As previously reported by Healthcare Informatics, some of the core health IT components of the legislation, as read in the “Title IV—Delivery” section of the law, include encouraging interoperability of electronic health records (EHRs) and patient access to health data, discouraging information blocking, reducing physician documentation burden, as well as creating a reporting system on EHR usability.
Drilling down, the interoperability and information blocking components of the legislation have seemed to garner the most buzz so far. The bill specifically defines interoperability as: (A) enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user; (B) allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law; and (C) does not constitute information blocking as defined in section 3022(a).
To this end, information blocking is defined in the law as, with respect to a health information technology developer, exchange, or network, business, technical, or organizational practices that, “except as required by law or specified by the Secretary, interferes with, prevents, or materially discourages access, exchange, or use of electronic health information; and the developer, exchange, or network knows, or should know, are likely to interfere with or prevent or materially discourage the access, exchange, or use of electronic health information.” And with respect to a healthcare provider, “such provider knows that such practice is unreasonable and is likely to interfere with, prevent or materially discourage access, exchange or use of electronic health information.”
What’s more, the act creates the EHR Reporting Program which will consist of reporting criteria on the product’s security, user-centered design, interoperability, and conformance to certification testing; among other categories, according to a College of Healthcare Information Management Executives (CHIME) handy crosswalk of the bill’s health IT provisions.
The Cures Act legislation doesn’t come without consequence or penalty, either: regarding information blocking, developers, exchanges, and networks found to have engaged in data blocking and who have submitted a false attestation would be subject to civil monetary penalties not to exceed $1 million per violation.
Certainly, industry stakeholders are paying attention to the bill’s “teeth” around interoperability, as they should be, says Mandy Long, chair of the Healthcare Information and Management Systems Society (HIMSS) EHR Association Clinician Experience Workgroup and vice president of product management at Boca Raton, Fla.-based vendor Modernizing Medicine. “It’s really about the ability and risk of the vendor, because if you are a vendor seen as [engaging] in data blocking, you are able to receive a penalty up to $1 million on a per violation basis. That’s really significant,” Long says. “And there is also the ability to potentially lose your [EHR] certification if you’re not seen as interoperable. Those are very real ramifications and big incentives for vendors do right by their clients. You have an entire client base that’s reliant on you to participate in these quality programs. Vendors will need to make sure they’re listening and acting,” she says.
To this end, Long says that the provider community is well aware of the impact of a product they are using becoming de-certified. “So they’re focused on pushing to make sure their vendors are submitting reporting criteria, listening, and acting so they can continue to leverage that technology. It’s not as simple as switching vendors, which is cost-prohibitive, time-incentive, and challenging to take a legacy system that has decades of patient data and convert that to a new platform. If I were a provider I would be nervous about that,” she says.
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