Medical Device Daily
VIENNA — More and more medical devices are plugging into information systems at hospitals and pushing and pulling data to diagnosis, track therapies and monitor patients. Increasingly, plug-and-play compatibility is the must-have feature of products coming to market, ending the strategic practice of creating stand-alone systems that lock in a family of products for a single company.
Currently voluntary industry programs aim to assure compatibility between competitive products, but more formal certification efforts are advancing toward the day when such a certificate may become as essential to purchasing decisions as the CE mark and FDA approval that assure product safety.
The World of Health IT conference held in Vienna last week revealed the progress of the government-led efforts toward medical device interoperability in a joint presentation made by the heads of programs in both Europe and the U.S.
The devices covered include anything that plugs into health information systems to send or pull patient data covering a range from complex medical imaging systems to point-of-care diagnostics, blood pressure monitors and even single-use disposable products.
The contrasts between the U.S. and European programs happen to be consistent with stereotypical cultural protocols.
The U.S.-developed program, the Certification Commission for Healthcare IT (CCHIT; Chicago), started with a clean sheet, and the program designed in 2005 is already up and running, testing and certifying products, moving methodically through in-patient informatics systems and now extending its footprint to a wider scope of devices and care settings.
Meanwhile, the European program, the European Institute for Health Records (EuroRec; Ghent, Belgium), faces a complex environment dealing with existing product interoperability requirements distributed unevenly across the 27 member states of the European Union (EU).
Yet, the slower-moving European initiative is proving to be “a very elegant approach,” according to CCHIT’s chair, Mark Leavitt, applying methods that he suggested may ultimately produce a more comprehensive and globally significant set of standards for product developers who necessarily need to look beyond home markets to the global opportunities for sales.
“After all, the certification standards we developed for the U.S. become only a single country subset for the larger collection of country requirements in Europe,” said Leavitt.
Funded by the European Commission Directorate for the Information Society, EuroRec is headed by the quiet but formidable Dr. Georges de Moor, who specialized in clinical pathology and nuclear medicine at the State University of Ghent, where he teaches health informatics.
Leavitt and de Moor shared the podium for a standing-room-only session at WHIT that for the first time laid out, side-by-side, emerging directions for medical device standards on both sides of the Atlantic.
The U.S. presents a market that as large and as fragmented as Europe for interoperability, Leavitt said, due to a legacy of the U.S. private financing for healthcare systems and past purchase patterns.
CCHIT was launched by the U.S. government in October 2005 with $7.5 million in funding for three years. Its objective: to accelerate the adoption of health IT and stimulate an interoperability that is robust, he told attendees.
Two years into the project, CCHIT is “in full operation, and we have results,” he said, a contrast to Europe, where the catalog of requirements is now taking solid form but is not yet ready for implementation.
The first U.S. certification of medical informatics products in 2006 was for ambulatory electronic health records against 247 established criteria. Among the estimated 200 vendors of such systems, some 40% presented for certification, representing 75% of the market share, Leavitt said.
Certification for in-patient EHR systems was launched in August, using 191 criteria. Vendors are in this market number 54, and, to date, six have presented their systems for certification, Leavitt said.
Vendors are required to comply 100% with the criteria with “no exceptions,” he added.
Leavitt said CCHIT has established a rhythm for building the criteria and tests, and each new product segment moves through a 12-month process from scanning the market, through analysis and publication of interim criteria, to the final published criteria.
Critics of CCHIT predicted that certification would push out smaller firms to the advantage of the major companies in a given field, but Leavitt said that three-fourths of companies seeking for certification are under $10 million in sales.
In Europe, de Moor said fragmentation presents not only a diversity of reimbursement systems and governments, but also varied medical cultures and languages.
His task is markedly different from setting up a certification system from scratch, as there already are multiple national and regional requirements.
EuroRec began in 2003 with funding from the EC to catalog these requirements for medical, administrative and nursing programs, and, significantly, work has begun on personal health records (PHRs).
In the U.S., Google (Mountain View, California) and Microsoft (Redmond, Washington) are rushing to capture this market, but in Europe the PHR — and requirements defining elements of patient data in this dossier — already is the established domain of as many as 19 governments who have announced programs and pilots building these records around electronic health cards equipped with onboard processing and memory chips.
de Moor said the focus for the catalog is terminology and coding systems, and today the repository holds 1,345 validated test criteria. The business function, as an example, indexes 50 separate functions in eight subcategories. As an example, security of data is considered a business function so that requirements for patient identification would be found in one of these subcategories.
EuroRec is operating in a transparent and open methodology.
de Moor defined “open” as meaning that EuroRec is gathering requirements as a recognized authority overarching Europe’s regional and national associations, comprised of essential stakeholders from hospitals, governments and practitioners such as surgeons.
After capturing and indexing the diverse requirements for a given area, the job of the institute is then to “harmonize” requirements, identifying similarities among countries and winning agreement for the collectively revised standard. Each criterion is translated into 12 different languages for the countries fully participating in the program.
The UK is not participating yet, but English is the program’s “default” language.
In a significant development for product developers or purchasers who are drafting requests for proposals, de Moor reported at the conference that while only limited validated criteria has been published on the EuroRec website, the institute is opening to public review its internal website, where all criteria are indexed.