Seal of approval

Government and commercial organizations are mounting programs to certify health IT products. But can they really spur adoption of the complex technologies?


With recent studies showing that only 20 percent of U.S. physician offices have bought electronic health record (EHR) systems and with the adoption rate by very small practices even lower, policy-makers have been looking for a way to boost the acceptance rate of the new technology. Product certification ' the sanctioning of specific commercial solutions by a
body of experts ' is now being seen as an essential driver in the acceptance of EHRs by the health care community.

David Brailer, former national coordinator for health information technology,
believes certification is essential because it would create a necessary trust
in physicians that the EHRs they buy will work with other IT systems and be
a worthwhile investment. 'A trusted marketplace is a growing marketplace,'
he told an audience at the third annual World Health Care Congress earlier this year in Washington, D.C.

Physician groups are now starting to stress the importance of using certified EHRs. A. John Blair, president and chief executive of Taconic IPA, a major health care delivery network in greater Hudson Valley, N.Y., has gone so far as to warn the organization's physician members that using noncertified
EHRs could mean a reduction in their revenues.

'Physicians choosing systems unable to meet certification requirements are at risk of not being able to receive future payer and purchaser incentives,' he wrote in a recent member newsletter. 'Taconic IPA has committed to its physicians that only certified systems will be endorsed by IPA.'

John Glaser, vice president and chief information officer of Boston-based Partners HealthCare System, also sees certification as an important basis for future payments. Payers may want to offer a financial reward for EHR adoption, he said, but they must be confident that they are supporting the purchase of a product that meets a minimum standard.

Glaser agreed that certification will give small health care providers some peace of mind about EHR purchases. 'They are not sophisticated purchasers, and the risk of a bad decision is higher,' he said.

However, how product certification stacks up against the raft of other concerns pressing on the health care community is far from clear. David Merritt, project director at the Center for Health Transformation, a health
care reform group founded by former House Speaker Newt Gingrich, said health care providers and hospitals are still more worried about issues such as funding and financing.

'We don't hear them talking about a need for certified IT products,'Merritt said. 'That's not to say certification is unimportant, but it definitely isn't a No. 1 priority.'

How it works

The main certification effort in the United States is being led by the Certification Commission for Healthcare IT (CCHIT), a private industry organization founded in 2004 by the American Health Information Management Association (AHIMA), the Healthcare Information and Management Systems Society and the National Alliance for Health IT.

In September 2005, CCHIT was given a three-year contract by the Department of Health and Human Services to develop and evaluate certification criteria and an inspection process for three areas of health IT products: ambulatory EHRs for office-based physicians and other providers, inpatient EHRs for hospitals and health systems, and the networking components through which they interoperate and share information.

The first batch of certified ambulatory products was announced last month. Inpatient EHR products should be announced around the same time next year, and networking components the year after that.

More than two dozen ambulatory EHR vendors offered their systems for testing at CCHIT facilities after publication of final certification criteria at the beginning of May, that number exceeded expectations, said Mark Leavitt,
CCHIT's chairman. There were also more than 170 applications from people to
serve as jurors for the certification process, including many from practicing physicians, and that number also exceeded expectations, he said.

So far, Leavitt feels the response to the CCHIT certification process is a good answer to critics who have expressed some doubt about certification and whether the process can really be fair to the plethora of products that are already out there or that vendors plan to introduce.

'I know people have been saying they are concerned, but I think the response [to the CCHIT process] shows the difference with the rhetoric,' he said. 'We've had more than two dozen vendors apply to have their products
certified, and we can hardly keep up with the demand.'

Leavitt said that for any products accepted for certification testing that hadn't
made it through the process by the July announcement date, testing would continue with additional certifications announced every two weeks until the backlog was cleared.

Additional groups of ambulatory products will be tested every quarter, with the next batch due Aug. 1-14. The results of that testing are scheduled to be announced in November.

International models

The move to have some form of certification help drive adoption of EHRs and IT by the health care industry is a growing trend outside the United States.
For example, Canada's eHealth Collaboratory, a joint initiative of Canada Health Infoway and the Centre for Global eHealth Innovation, is putting certification at the core of its activities.

'A main reason for our existence is to provide conformance and certification services for the Canadian push in e-health,' said Kees Schuller, the collaboratory's new executive lead. 'We function as a trusted authority
so that people know solutions meet our standards, and anyone making a purchasing decision knows that solutions certified by us conform to those standards.'

Although officially launched May 8, the collaboratory completed its first operational phase March 31 by implementing services for evaluating the interoperability and usability of EHR solutions according to a set
of pan-Canadian standards.

The collaboratory has received seed funding from the Canadian government and uses assets provided by large health districts in Ontario. It also has active support from Canadian vendors, with 10 contributing their time and expertise during the collaboratory's first phase.

'We've had a fairly broad demand for these conformance and certification services, from standards-setting bodies such as InfoWay and others to hospital systems and other jurisdictions through to the vendors themselves,' Schuller said. 'If they didn't have this through the collaboratory, they all
know they would eventually have to jump through these [certification] hoops themselves, and they only want to go through it once.'

No date has been set for the beginning of certification testing, he said, but an announcement could come by the end of August, with the goal of beginning within the next year.

Private certification

Certification is also starting to become an issue for particular areas of IT products. In June a group of 22 electronics and health care companies announced the formation of the Continua Health Alliance, whose members include the likes of Intel, IBM, Motorola and Cisco Systems as well as major
health IT organizations and users such as Medtronic, GE Healthcare, Kaiser Permanente and Partners HealthCare Systems.

Continua's goal is to define standards and guidelines that will ensure the interoperability of IT devices that people can use at home or on the road to keep a better eye on their own health and enable them, along with caregivers and health care providers, to manage their health more proactively. Continua will also certify products, identified by the Continua logo, that will interoperate and share data with other Continua-certified
products.

'We are operating on the principle [that] the capacity problem [in health care] has clearly been lost,' said Joseph Kvedar, director of Partners Telemedicine and a Continua supporter. 'And the number of chronically
ill patients just keeps growing.'

The expansion of home-based health care, where patients take on a good deal of the responsibility for their own care, is one way to address that, he said. But that requires the development of a whole ecosystem of connected health IT products that can be monitored remotely. 'Certification will certainly
drive adoption of these products,' he said. 'It would take a lot longer without it.'

It's very early in the process to know if this will actually happen, Kvedar said, but Continua hopes to have certified products available in the next two to three years.

Certification coordination

It's important that the various certification bodies make sure they are on the same page, Leavitt said, so representatives from CCHIT and Continua have already been talking about how they can make sure they are always
using the same language when it comes to their respective endeavors.

If used properly, the certification process may in fact produce a good two-way discussion between vendors and physicians about what features health IT products should contain, said Donald Mon, vice president of practice leadership at AHIMA.

'In our communications with physicians and other health care groups,
we've stressed the need for them to use the certification process to communicate these kinds of things to vendors,' he said.

'We've also pointed out to vendors that they can use these discussions to
find things they can use to differentiate themselves from others in the marketplace,' he added.

The certification process only tests for a minimal set of interoperability and
other needs, he pointed out, and that leaves plenty of room for vendors to develop other features they can use as competitive selling points.
'What vendors get from certification is a level of confidence that their products will play in the marketplace,'Mon said. 'But there's still a lot of room for them to innovate.'

It's still early in the certification process, and all sides are still trying to work out just what it means for them, he said. And even though CCHIT and others
have been trying to get the word across in the two years certification has been discussed and debated 'in all candidness, there still needs to be more education,' he added.

Nevertheless, even the current level of understanding shows that physicians
are clearly getting the message about what certification can do for them and
for the adoption of health IT, Mon said. Long-term impact Some still question what long-term effect certification will have on the health IT market. Although most people are convinced it has a role in kick-starting the early adoption of health IT, that role could fade over time.

After all, there is already evidence that the market can produce its own interoperable standards.

When the need to share X-rays and other kinds of images between hospitals
and other health care facilities became necessary, vendors responded by agreeing on the means to do that, said Charlene Underwood, chairwoman of the EHR Vendors Association.

Even without CCHIT, she said, the industry would likely move to create
standards as the need arises.

Does that mean certification will inevitably give way to the market?

Victor Plavner, chairman of the Maryland/D.C. Collaborative for Healthcare
Information Technology, a coalition of health care providers representing more than 3,000 physicians in Maryland and the District of Columbia, said he believes some kind of certification is necessary to guarantee health IT connectivity for the future.

But, he said, just like the Good Housekeeping Seal of Approval, people don't
always buy products or services based on a certification.

'I still think the market will play out according to the value the product or services bring,' Plavner said.'However, it may be that with such a big price tag some kind of certification will be necessary.'

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