More Focus Needed on Merging EHR, EDC, Experts Say

Merging electronic health records (EHRs) and electronic data capture (EDC) is about more than finding the right technology, said experts gathered last week at a conference in Washington, D.C.

In fact, the technology to do it is here today, said Les Jordan of Microsoft. But technology alone can't overcome other barriers, said experts at the ExL Pharma conference, including:

A lack of standards; 21 CFR Part 11 and Health Insurance Portability and Accountability Act compliance challenges; A hefty start-up price tag; and A generally risk-averse pharmaceutical industry.

Technical standards are the first step, Jordan said. "Creating the technical standards to support [merging EHR and EDC] won't solve the problem" alone, but it's necessary, he stressed.

"It's not just the technology," agreed Jules Mitchel, president of eCRO Target Health. He said potential barriers can be overcome, but all in industry must work together to address them. "It's more about the commitment" to the technology, he added.

The stakes are high, experts at the conference agreed. "The benefits [of doing it right] can be huge," Mitchel told PIR Sept. 22. For example, monitoring time for contract research organizations could drop by more than a third, he said.

Part 11 Challenges

While not the only issue, Part 11 compliance has emerged as a nettlesome problem for merging EDC and EHR, experts said. (See related story) (http://www.fdanews.com/Admin/issues/pir/6_19/technology/60625-1.html). Pharmaceutical companies tell anyone developing software for them that it must be Part 11 compliant, Mitchel said.

The problem is that when it comes to EHR/EDC merging, it is difficult to validate the data coming into the system at the source, he and others at the conference said. It is problematic for current EHR/EDC systems to create audit trails with validation at the source, in part because the physician ultimately using them has no control over the creation of the EHR itself, Mitchel explained.

While the FDA may have to ultimately weigh in on the issue by revising Part 11 to address data sources or issuing a new regulation, Mitchel said it might also work to develop some kind of certification that adheres to industry best practices. This good practices certification may not literally be Part 11 compliant, but it could be designed in such a way as to maintain data integrity, he said. "Data integrity is the main thing."

Another important area to address is that of forms and workflow, Mitchel said. Pharmaceutical companies develop their own electronic forms and the EHR industry should work with them to develop compatible template forms that can be used by all companies, he said. "If the systems are not compatible there will be a lot of problems."

For example, if systems can't "talk" to each other, EHR data will have to be entered twice. In some cases, pharmaceutical companies are reduced to having two computers side-by-side while data from one system is entered again into the second system.

But the pharmaceutical industry's reputation for being risk-averse, especially when it comes to adopting new technologies, isn't helping either. "The big problem in pharma, like other industries, is the feeling of 'if it ain't broke why fix it?'" Mitchel said. "I've talked to high profile pharma people who still say to me, 'Jules, paper works.'"

While smaller pharmaceutical and device companies often embrace new technology and ideas immediately, at the bigger ones going paperless can set off "epic battles," Mitchel said. "Companies are usually happy once they do it, but the battle to give up paper is big," he said. -- Michael Causey