For many clinicians, the concept of “certification,” especially when it comes to specialty boards of medicine, connotes passage of a highly rigorous and robust test after multiple years of training and study. The expectation that “certified” HIT connotes an equally high level of testing of patient care functionality is not surprising. The reality, however, comes into sharper focus when looking at the definition of certification — which is simply the assurance that certain defined characteristics are present. It can be done at the first level, which is nothing more than the developer’s personal word; at the second level, which involves an overarching organization of similar developers or persons attesting that the characteristics are present; or at the third level, which provides maximum confirmation through independent review, testing, assessment or audit. No matter what the approach, for HIT product certification to truly be of value to interested parties, those parties need clear knowledge of the rigor of the certification program, what it intends to accomplish and its criteria.
The goal of electronic health record (EHR) certification currently administered by the Office of the National Coordinator of Health Information Technology (ONC) is to assure providers that their EHR technology will meet minimum standards in support of Meaningful Use objectives and measures, thus meeting technical eligibility for incentive payments. This is done by a robust third level testing and certification program that meets this goal. There are other features and functions not included in ONC certification, however, that many providers may wish to consider using other evaluative methods.
First and foremost on the list of evaluative approaches beyond ONC certification would be integration testing to assure that all HIT related products can work together in a particular clinical environment. If products are not integrated, interfaces may need to be built between various modules or systems, adding significantly to cost. EHR users may need to find alternative ways to demonstrate that various system components can support functions relying on data integration.
Interoperability of one EHR with another and with entities to whom providers must report is also key. While some interoperability testing is inherent in the ONC certification program, more is required to assure access to critical information at the time it is needed. HealtheWay, a public-private partnership that has evolved from the ONC-developed Nationwide Health Information Network (now referred to as the eHealth Exchange), has partnered with the New York eHealth Collaborative-led EHR/HIE Interoperability Workgroup, a coalition of 15 states and 37 EHR vendors, to assure this more robust level of interoperability. CCHIT has been named the Compliance Testing Body for this partnership and will certify that the technical aspects of health information transport are met to enable reliable transfer of data within and across organizational and state boundaries.
Usability testing is still in its early phases. There is now universal agreement that usability in the HIT environment is characterized and informed by the science of user-centric design (UCD) and both formative (done as part of the development process) and summative (comparing one system with another using standardized formats) testing. Past CCHIT experience with objective testing that included reporting of usability ratings, current research on usability funded by ONC grants, and the practical application of new approaches to assessing usability will likely allow for more evaluation of HIT usability in the near future, with new usability ratings publically available. In the interim, the National Institute of Standards and Technology (NIST) has made a set of principles and guidelines that can be used to increase usability in the provider setting available on their website.
Every vendor and developer needs and wants to assure that they have incorporated state of the art security protections in their HIT. HIT users will need to keep in mind, however, that security testing and certification is not included for ONC certified modules that are certified separately from a “Base EHR.” While there is no question that most security breaches are the result of human activity, hackers continue to attempt to find financial information wherever they believe it to be — including provider and health plan settings. Providers must therefore rely on their vendors’ attestation that the highest level of security precautions has been implemented.
Patient Safety features are another area that has not been well defined, and no programs have been developed to specifically assure that they are included. However, we do know from reviews of malpractice claims that most are related to lack of communication and lack of follow up after a test, procedure, medication, or referral has been ordered. Providers should evaluate their own systems to be sure that multiple users in the clinical setting can access and use the record simultaneously, that data can be shared easily within the provider settings, with the patient, and with clinicians external to the provider system. They should also look for “closed loop ordering” functions: assuring that the system notifies the ordering clinician when there is no result, no followup, or no evidence of a prescription being filled as ordered.
Surveys offer some insight on how peers might evaluate a particular system. These are generally conducted by physician groups such as the American College of Physicians or propriety entities. While these do not include objective third part assessment, they can certainly provide indications of problems as well as particularly useful features of various products.
Lastly, as more and more provider groups — both physician and hospital based — look toward various models of Accountable Care, they should consider the fact that an EHR alone will not meet all their need for providing care that meets the Triple Aim of high quality, efficient cost, and strengthened patient relationships with available and access to care.
As it evolves, the HIT landscape is clearly becoming more and more complicated; ONC certification will continue to provide assurance that EHRs will meet Meaningful Use program goals through its various stages. This is an important first step when thinking and planning for the more robust HIT that will be necessary to care for patients effectively and efficiently in the future. Providers of all types will need to be mindful of other ways of assessing these technologies.
Karen M. Bell, MD, MMS
Chair, Certification Commission
Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®. Dr. Bell has wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Previously, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system. Between 2005 and 2008, Dr. Bell was Director, Office of Health Information Technology Adoption, Office of the National Coordinator (ONC), U.S. Department of Health and Human Services (HHS), and, in 2006, served as Acting Deputy of ONC. She was ONC’s representative on CCHIT’s Board of Commissioners from 2006 to 2008.
Prior appointments held by Dr. Bell include Division Director, Quality Improvement Group/Office of Standards and Quality for the Centers for Medicare and Medicaid (CMS), and Medical Director of Blue Cross Blue Shield (BCBS) of Rhode Island and of Anthem BCBS of Maine.
She received her medical degree from Tufts University School of Medicine, Boston, and her master of medical science degree from Brown University, Providence, R.I. Dr. Bell has clinical experience as a board certified physician in internal medicine and also was an Associate Professor at the University of Rochester, and Clinical Instructor at Harvard University School of Medicine.