This appeared earlier in the week:
A Step toward Interoperability of Health IT
- David Blumenthal, M.D., M.P.P.
- December 10, 2022 DOI: 10.1056/NEJMp2213873
Although virtually all patient information is now recorded electronically, the persistent inability to move this information easily from place to place has remained a major frustration for patients, clinicians, and policymakers in the United States. It wasn’t supposed to be this way.
The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, which used incentives and penalties to spur rapid adoption of electronic health records (EHRs), also envisioned private and secure health information exchange for the country.1 Robust exchange of patient data has the potential to improve the quality of care and support efforts to hold key actors accountable for its costs.
But technical and economic obstacles have prevented the realization of this vision. Now, by adopting a regulation that went into full effect on October 6, 2022, the federal government has taken a potentially important step toward effective exchange of health information. The regulation was issued by the Office of the National Coordinator for Health Information Technology (ONC), an agency within the federal Department of Health and Human Services (HHS), which is implementing provisions of the 21st Century Cures Act.2 Enacted in 2016, the Cures Act was intended to address both the technical and economic barriers to health information exchange.
The technical obstacles come in two forms. First, it has proven complex and costly to connect the many EHRs that providers have adopted. Second, there was a lack of consensus regarding the full set of standards for defining and communicating about clinical terms in patients’ records. Implementing such standards would ensure that terms have the same definitions in software used in various records, so that the records present exchanged information to EHR users in a meaningful way.
The economic problems affecting information exchange reflect the underlying structure of the U.S. health care system. For better or worse, Americans have come to treat health care as an economic market much like any other, in which competition should be a primary means of reducing cost and improving quality. But if providers are expected to compete, why should they share information? Patient information is a competitive asset. It can help cement patient loyalty and reveal approaches to care that may confer a competitive advantage. In other words, in competitive health care markets, information exchange has major potential costs to providers and few obvious financial benefits. Policymakers would never expect automobile or semiconductor makers to voluntarily exchange information.
Market incentives have equally problematic implications for EHR vendors. If vendors make it easy to move information between records, they make it easy for providers to switch from their record to a competitor’s product.
The Cures Act addressed the technical obstacles to information exchange by requiring EHR vendors and care providers to adopt modern Internet-based exchange technologies, such as application programming interfaces, that facilitate connections among diverse EHRs as well as other health information technology (IT) systems. The aim was to permit access to information “without special effort.” The law also required the adoption by EHR vendors and providers of newly curated consensus standards for key clinical terms.
In addition, the Cures Act targeted economic barriers to information exchange. It directed HHS to define what it called “information blocking”: the failure to respond readily to requests by authorized parties to share patient information. HHS is also tasked with establishing and implementing economic penalties for providers, vendors, and health information networks — entities that act as conduits for information exchange and thereby hold patient data — that engage in information-blocking practices. The law threatens EHR vendors and health information networks with penalties for violating the regulations of up to $1 million per incident. In addition, EHR vendors that obstruct information exchange could lose critical federal certification. With regard to providers, the Act didn’t specify penalties for noncompliance but directed HHS to come up with “appropriate disincentives.”
The Cures Act also enhanced patients’ access to their own health information under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). HIPAA gave patients the right to timely access to their health information in paper form. The Cures Act stipulated that patients or any third party they designate should promptly receive the contents of their electronic records in machine-readable form. This provision opens the door to a new industry that could sell electronic information-management services that gather, analyze, and present data contained in dispersed EHRs — presumably with appropriate privacy protections — to patients, providers, and other parties.
Aware of the remaining challenges associated with health information exchange, the ONC has implemented the Cures Act in phases. A final information-exchange regulation was initially published in May 2020. The ONC then twice delayed the deadline for compliance in response to industry requests amid the Covid-19 pandemic. The rule went into effect on April 5, 2021, with an 18-month phase-in period. It first required exchange of a limited set of data known as U.S. Core Data for Interoperability,3 which consists of basic information such as patient demographics, medications, and test results. On October 6, 2022, the regulation went into full effect. Providers and other entities must now share “all electronically accessible health information,” as per the Cures Act.
Industry stakeholders are publicly supportive of the aims of the Cures Act and the information-exchange regulation. Hospital and other provider groups nevertheless asked for an additional 1-year delay in implementing the new rule, citing various concerns.4 Among these concerns is that small practices and facilities and rural providers may lack the technical expertise to comply with the rule. Provider groups are further concerned that HIPAA privacy protections don’t extend to the many IT companies that now hold patient information.
More here:
https://www.nejm.org/doi/full/10.1056/NEJMp2213873
This is really a good summary of where things are up to with the rather sad observation that overcoming the barriers to interoperation and the associated Standards are still very much a ‘work in progress’.
My feeling is that we come back in a decade to see if it is sorted yet? I fear, however, that this may just be too optimistic. What do you think?
David.
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