Medical Device Daily Washington Editor

WASHINGTON — Healthcare information technology, or HIT as it is affectionately known, continues its steady creep into the practice of medicine, and Michael Leavitt, secretary of the Department of Health and Human Services, recently reported that the department has accepted a set of 30 standards that will help ensure software interoperability and personal data privacy, among other things.

However, the documents describing those standards indicate that, near-term at least, HIT might not achieve universal interoperability for operating systems (OS).

The Healthcare Information Technology Standards Panel (HITSP), the body responsible for crafting those standards, was formed specifically to deal with interoperability and several other looming issues — including privacy and security — and is charged with ensuring that all the software vendors’ products fit more or less neatly into the Nationwide Health Information Network (NHIN).

HITSP is sponsored by a partnership of the American National Standards Institute (ANSI; Washington), the Healthcare Information and Management Systems Society (HIMSS; Chicago), the Advanced Technology Institute (ATI; Virginia Beach, Virginia) and government contractor Booz Allen Hamilton (McLean, Virginia). HHS is funding the effort via the ONCHIT1 contract award from the U.S. Department of Health and Human Services.

ONCHIT1 is, in turn, the first in a series of requests-for-proposals issued by the Office of the National Coordinator for Health Information Technology (ONCHIT), tasked with steering the herd of Information Age cats together long enough to guarantee that their programs will promote, rather than impede, the march of HIT into modern medicine.

HITSP actually delivered its 30 recommendations to the American Heath Information Community (AHIC) last October, and it passed the HITSP standards along to Leavitt with its seal of approval shortly thereafter. AHIC is a federally chartered advisory body responsible for keeping the HHS secretary abreast of HIT developments.

Because a recent Executive Order requires that any federal purchases of new or upgraded health information systems after 2007 comply with the HITSP standards, the impact of the 30 standards promises to be substantial, given Uncle Sam’s appetite for information technology.

According to the standards documents, the interoperability specifications for patient identification “focuses on a set of constrained data standards . . . that address the core requirements,” but “does not define all functions, constructs and standards necessary to implement a conforming system in a real-world environment.”

The standards are also said to be architecturally neutral by intent, which presumably makes the standards insensitive to different OS.

On the other hand, the document that describes patient ID standards acknowledges that in some instances, the questions of the type of a data exchange could “constrain, to some degree, the total range of choices regarding system architecture.”

Because most computer OS architectures are written to work with a limited number of system features, including microprocessor architecture, compatibility across systems could be compromised.

The vehicle of information transmission also presents some dilemmas.

The document addressing patient ID states that “there is an ongoing debate concerning the proper role of messages and documents as methods of data exchange.”

The characteristic of persistence is said to draw the line between messages, which the document describes as “typically non-persistent encapsulations of highly structured data that require external context,” and documents, defined as “persistent encapsulations of both data and context.”

Needless to say, there is an independent standard for persistence, which is embodied by the so-called HL7 standard. HITSP standards will also account for situations in which “requirements for both messages and documents exist and, where consistent with harmonization, will support both.”

NIH to reach out on research priorities

With a budget nearing $30 billion, the National Institutes of Health (NIH; Bethesda, Maryland) has the fattest research wallet in the world, and the agency is reaching out to stakeholders for input on how it might best spend that money.

The NIH recently said that it will hold a half-dozen workshops this year to “solicit input from leaders of the scientific community and other stakeholders,” according to the announcement.

Coordinated by the Center for Scientific Review (CSR), these meetings will commence next month and will “help NIH better advance medical research and serve the American public and all those suffering or at risk who need new treatments, cures and preventions,” said CSR director Toni Scarpa in a statement.

CSR is responsible for organizing the peer review groups that go over most of the grant applications taken in by NIH, which, when added to the public health service grants it reviews, total more than 80,000. The office has to recruit about 18,000 experts in these fields each year to staff the review groups and assigns each grant to the appropriate center or public health service agencies.

Scarpa said that the meetings are crucial if NIH staffers expect to stay up to speed on developments in the world outside of Bethesda.

“The rapid evolution and expansion of science has made it much more difficult for our peer review groups to keep pace,” she noted.

The workshops will also give stakeholders an opportunity to comment on CSR’s peer review process, which is said to have gone without substantial oversight by the scientific community since the NIH Panel on Scientific Boundaries for Review wrote and released its reorganization plan in 2000.

NIH is encouraging members of scientific societies and disease groups to make their voices heard at these workshops, where they can speak with administrators and CSR senior staff.

The first session, scheduled for March 2, will zero in on NIH’s neuroscience work and will be held at the Natcher Conference Center at the main NIH campus in Bethesda, Maryland. The remaining workshops will take place every other month throughout the year and will address research into, among other areas, behavioral and social sciences and integrated biological sciences, the latter of which will be covered in two workshops.

Input received from these workshops and the public comment period will be presented to the NIH Peer Review Advisory Committee, which will guide CSR as it works to implement changes and address concerns raised at the open house meetings.

Larry Soler, the vice president of government relations for the Juvenile Diabetes Research Foundation (New York), said in a statement that his organization “is working with NIH to support clinical trials to test the effectiveness of continuous glucose monitors in key populations that are complementary to the clinical trials that JDRF is funding.”