Electronic Health Record Adoption Struggles Without Standards
Medical device manufacturers, physicians' offices and others involved in the edata chain of patient information are struggling to adopt electronic health records (EHRs) because of cost barriers and a lack of standards, experts told PIR last week.
While some smaller medical devicemakers and others are calling on the FDA to issue a "Part 11-like" rule mandating standards, many others in industry worry that that would be a prescription for excessive cost and confusion much like the result of the 1997 Part 11 rule for ehealth records. "Instead of doing a good thing, that might stifle the technology," said Rita Geiger, president of InfoStrength. Industry generally lauds EHRs and sees a number of benefits from a cohesive program with clear standards, including:
Rapid sharing of critical medical information across a currently fragmented healthcare delivery system; Reduction of costly and redundant treatments and preventing medical errors; Improved patient information privacy capabilities; and Increased efficiency by automating drug prescriptions and submitting payment claims.
But the standards issue is tricky on a number of levels, said Kenney Andersen, product manager at SunTech Medical, a company that creates interfaces between medical devices and EHRs. With an estimated 17,000 medical device companies in the U.S. alone, the number of devices and situations where they must communicate with physicians' offices and elsewhere is staggering, he said. "When we talk about standards we are by necessity talking about numerous sets of standards because there are so many different levels and facets and interconnects in sharing the ehealth data," he said.
An electronic record of patient health information can include data on: patient demographics; current treatments and progress notes; medications and potential drug interactions; vital signs; past medical history; immunizations; lab data; x-rays and magnetic resonance imagery and radiology reports.
Andersen's firm offers a product that can deliver a patient's vital signs electronically to a physician. The standards for that product will be relatively straightforward, he said. But they have another product that provides 24-hour patient monitoring that generates much more data and relies on software standards. This product will demand more layers of standards, he said.
Further complicating the standards issue: the FDA doesn't believe it has authority to mandate standards, and defers to HHS, Geiger and Andersen agreed. HHS is awarding grants to organizations including the Certification Commission for Health Information Technology (CCHIT), an industry group for standardization and certification of EHRs, and HHS' own Office of the National Coordinator for Health Information Technology (ONCHIT), which is part of President Bush's order to promote the development of a nationwide interoperable IT infrastructure.
Others working on the standards issue include the Institute of Electrical and Electronics Engineers (IEEE) Standards Association, which has developed IEEE 1073, a medical device communications standard for patient data communication for medical devices, and the American Health Information Community, established to provide recommendations to HHS on making digital health records interoperable.
But even the most optimistic in industry say we could be five years away from establishing standards, and perhaps another five years from their being adopted in significant numbers by industry.
Saying he was by no means sold on a Part 11-like approach, Andersen said there was a clear need for the federal government to weigh in on and stay involved with the standards issue. "We need some kind of government role to influence device and software companies to make sure that once standards are agreed upon, they implement them."
Geiger applauded government's push for a certification program, saying that competition within industry may be a huge driver toward standards adoption. "Think of two blood pressure devices [with roughly equal capabilities and costs] where one can say it has the certification and the other can't," Geiger said. "That certification can be a big competitive advantage to the company that has it."
Standards aside, cost issues remain a big barrier to faster EHR adoption, Andersen said. "While adoption has been slow, it is happening and I expect it to continue to rise in the next ten years." He said adoption has been slower at larger, more established physicians' offices because they have more paper records to convert or scan to a new system. Faster adoption is coming from younger up-and-coming practices that know a long-term investment makes sense, he said. -- Michael Causey