A Medical Device Daily

From medical device development to patient-doctor discussions, the U.S. healthcare system could be improved by embracing much more openness.

Politicians and regulators grapple over laws to protect patients and insure safety. Healthcare providers work to treat the sick and injured, and make sure their personal data remains private in the process. And the owners of medical devices and drugs need payback for their research investments, so they protect their intellectual property. What’s the common thread to improve the healthcare continuum? “Harnessing Openness to Transform American Health Care,” a report released by the policy research group Committee for Economic Development (CED, Washington), insists that openness among all of the key health players can realistically lead to improvements in care as well as benefiting corporate America.

“If I have an idea and hide it under the mattress, then a good idea is wasted,” Elliot Maxwell, project director for the report and fellow, communications program, Johns Hopkins University (Baltimore, Maryland) told Medical Device Daily.

He points to the Human Genome Project as a classic example that demonstrated the value of mass collaboration and the beneficial results of allowing data to be accessed immediately and manipulated by researchers around the world.

With this in mind, the group looked at how openness was being or might usefully be employed throughout the healthcare arena to facilitate collaboration, speed research, stimulate innovation, lower costs, reduce errors, and close the gap between discovery and treatment delivery. It also made a series of recommendations on how to get the ball rolling.

The report focuses in part on biomedical research and the disclosure of research findings, the processes for evaluating drugs and devices, the emergence of electronic health records, the development and implementation of treatment regimes by caregivers and patients, and the interdependence of the global public health system.

The report found that it takes 13-17 years for 14% of research findings to get into general medical practice. It recommends greater openness by making information available under far less restrictive conditions and increasing the ability of others to contribute.

As device makers chime in saying their IP cannot be shared because the value will be lost, Elliot begs to differ.

“Look at the IT world. Open source software standards have expanded markets,” he said.

Specific recommendations for the medical device industry include:

• The FDA should begin an inquiry into long-term regulatory treatment of software-controlled medical devices given the innovation potential demonstrated by the open-source software movement and the history of user-led innovation in scientific instruments.

• The FDA should engage the private-sector device community and federal research agencies to stimulate greater interoperability among medical devices and greater standardization of data outputs to facilitate the creation and use of integrated data sets.

“As devices become more computational, the possibilities for innovation become even greater,” Elliot said. “But there is a real tension with how we’ve traditionally regulated devices. In the device world, the only way you’re protected from liabilities is if you get FDA approval. FDA approves devices as they are submitted.

“If someone opens the hood of the device and changes the software, that someone doesn’t have protection from liability.” “In the future,” Elliot said, “we need to think through that model. Is there a different way of insuring safety and efficacy while still having innovation?”

Elliot proposes that device makers engage more physicians to be part of the innovation process.

“There should be a model in place for doctors to bring ideas to medical device companies on how to improve a product and they should be rewarded for the suggestion,” he said. “We need to design systems that make them friendlier to innovation. And if that’s going to get me in trouble with the FDA, then the FDA needs to figure out how to get that innovation into practice without having regulatory barriers in place. Look at the drug arena. When you have a new use for a drug, you don’t necessarily have to go through a whole new trial. The same holds true for innovative ideas for devices.”

Other areas addressed in the report include:

• Biomedical research is being transformed by the success of the Human Genome Project, which demonstrated the possibilities of mass collaboration and the beneficial results of allowing data to be accessed immediately and manipulated by researchers around the world. The report recommended that federal research agencies push further by enunciating clear policies favoring openness, funding further work on standards for protocols, formats, terminology and nomenclature that allow the sharing and manipulation of data, and supporting experiments with differing levels of openness to determine the optimal level of openness for research under various scenarios.

• Questions about the openness of clinical trials have been raised vigorously over the last decade. Although the FDA requires the registration of clinical trials involving life-threatening interventions, there have been disputes as to the completeness of these registrations — and about the lack of registration of other clinical trials. The report calls for greater availability of data from trials in electronic form to speed research and detect possible safety problems.

• The use of electronic health records could eventually be constructed to include family medical histories, genomic and pharmacogenomic data, environmental exposures, lifestyle and other information. The aggregation of such records and others could then facilitate the achievement of an evidence-based medical system. Such records provide far richer data than clinical trials, according to the CED report, and could serve as the basis for predictive models similar to those used in other scientific domains.

But those records can only be built if a healthcare provider has time to really listen to patients.

“This issue of openness exists in how patients and doctors interact,” Elliot said. “If you think about the patient as a source of information, interactions between the doctor and patient change and it becomes a different relationship. Doctors need to listen better but because of time pressures and training, they start to close down quickly during visits and conversations end with a diagnosis. We may lose some things in this kind of interaction. Conversely, we need to give the doctor assistance in screening through the explosion of information.”

More openness can work beneficially in hospitals too. For example, hospitals remain leery about reporting medical errors and are burdened with patient records privacy laws.

“If the incentives exist not to report medical errors, then it’s like putting a gun to your head,” he said. “The only way to stop medical errors is if you know about them. You can’t prioritize activities or figure out ways to do things better without openness. You have to start with the right incentives for people to report them.”

Elliot draws an example from New York taxicab accident rates. “Ten years ago we didn’t have little red lights on the backs of cars at eye level when the brakes were hit,” he said. “Taxicabs in New York which had those extra brake lights had lower accident rates. Lo and behold, now all cars have those brake lights at eye level and it has improved overall accident rates.”

The same holds true for errors at hospitals.

“This is a ‘duh’ moment: Medicaid is not going to reimburse extra costs associated with errors that could have been prevented. If your medical error is preventable, that’s costing you money, you’ll fix it. Get the incentives right to propagate the improvements,” he said.

The bottom line goal of the report is to get all of the sectors of the American healthcare system on board with the idea of sharing information, which would provide more possibilities for contributions of expertise and energy.

“Greater disclosure raises issues such as the potential for misinterpretation of reports and the gaming of FDA processes by competitors,” according to the report. “But these possibilities are outweighed by the gains from having the active participation of patients and practitioners who experience adverse reactions on medicine’s front lines.”

Other than stimulating thought, where does CED and the report go from here?

“We wanted to show that there’s a common theme in healthcare,” Elliot said. “Now, we’ll put together an agenda to show these linkages, make specific public policy recommendations and hope that we can build an agenda for openness.”