Printed in the Legal Intelligencer, January 31, 2017

Written by:   Vasilios J. Kalogredis, Esquire. and Katherine E. LaDow, Esquire.

The 21st Century Cures Act (“the Act”) is a United States law enacted by the 114th United States Congress in December 2016. The Act was passed by the House of Representatives on November 30, 2016, and the Act received overwhelming support from the Senate receiving a ninety-four to five vote in favor of the Act on December 7, 2016. On December 13, 2016 President Obama signed the Act into law. In general, the Act authorized $6.3 billion in funding, mostly for the National Institutes of Health. But the Act also contains a number of provisions directly impacting the healthcare technology industry. This article will focus on the Act’s prohibition of electronic information blocking and the serious implications affecting developers of software whose programs interfere with doctors and other healthcare providers sharing patient data.

In order to promote interoperability of electronic patient data, the Act authorizes the Health and Human Services (“HHS”) Office of Inspector General (“OIG”) to investigate any claims of information blocking among health-information vendors. The Act further authorizes the Inspector General to impose civil monetary penalties upon health-information vendors who impede efforts to promote electronic interoperability. The Act specifically defines “interoperability” as: software that (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).

For interoperability to be attained, vendors must not engage in information blocking. 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.”

The Cures Act legislation does not 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. The Act provides several examples of prohibited practices that could subject technology developers/ providers to civil monetary penalties. Some of these examples include: 1) implementing Health Information Technology (“HIT”) in ways that are likely to restrict the access, exchange, or use of electronic health information with respect to exporting complete information sets or in transitioning between HIT systems; and 2) implementing HIT in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging, or using electronic health information.

Certainly, industry stakeholders are paying attention to the bill’s “teeth” around interoperability, as they should be. There is the risk that a vendor, seen as engaging in information blocking, could face up to a $1 million fine per violation. There is also the ability to potentially lose one’s EHR certification if things are not seen as interoperable. Those are very real ramifications and big incentives for vendors to do right by their clients. A vendor’s client base is reliant on it to successfully participate in the various quality programs. Vendors will need to make sure they are listening and complying.

Other than imposing penalties and cracking down on information blocking, the Act also includes provisions and guidance to promote/ improve interoperability. The Act requires the Office of the National Coordinator (“ONC”) for Health Information Technology to coordinate with the National Institute of Standards and Technology and other agencies within HHS to roll out public-private partnerships intended to develop support for interoperability. Within six months of the Act’s enactment date, the ONC and its partners will also be required to develop a common agreement for national health-information exchange and establish a trusted exchange framework. To help with the development, the Act created the Health Information Technology Advisory Committee and the Health Information Technology Standards Committee. The ultimate goal is to establish guidance and details for authenticating health information network participants, establish a common set of rules for information exchange, and establish policies and procedures governing the exchange of information among the health networks.

The Act also includes language that lifts regulations on some software used by physicians, incorporating the idea that if software is supporting a physician’s practice, it should not be regulated by the Food and Drug Administration. Healthcare attorneys are hopeful that the Act will provide much needed clarify as to what will actually be regulated under the legislation.

The Cures Act is the most significant federal legislation in years to promote interoperability and the free exchange of health information. This open information exchange will help improve healthcare and care coordination. It is important to seize this opportunity by working to help make the Act a success and promoting the positive change that it has started.

To read the full text of the 21st Century Cures Act visit: http://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf.

Written by Lamb McErlane partner Vasilios J. Kalogredis, Esquire.* Katherine E. LaDow, Esquire, an associate with Lamb McErlane P.C., contributed to this article.

Vasilios (“Bill”) J. Kalogredis is Chairman of Lamb McErlane’s Health Law Department. Bill has been practicing health law for over 40 years, representing exclusively physicians, dentists, group practices, other health care professionals and health care-related entities.

*Katherine (“Katie”) E. LaDow, Esquire, is an associate in the litigation department at Lamb McErlane PC. She concentrates her practice in the areas of state civil litigation, family law and health law.

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