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Health data industry fights FDA oversight

Says safety rules would impede computer work

WASHINGTON — The fast-growing industry that makes digital medical records, the computer systems that can help doctors, hospitals, and insurers quickly keep track of patients, is gearing up for a Washington lobbying fight against federal safety regulations.

The outcome is expected to profoundly impact what has become an important tool in the health industry, one that has been aggressively encouraged and heavily subsidized by the federal government under the assumption that it will increase efficiency, reduce costs, and improve outcomes for patients.

The Obama administration plans to release recommendations in the coming months on how information technology systems used in the industry should be regulated for safety. At issue is whether the systems should be considered medical devices, and therefore regulated by the Food and Drug Administration just as a cardiac stent or a pacemaker is regulated.


Backers of FDA regulation say digital records systems sometime contribute to prescribing errors and other patient mix-ups that can have dangerous, even fatal, consequences. Bad or missing data in a patient’s computer record, for instance, can lead to catastrophic medication errors.

But the health care industry, including many top hospitals as well as manufacturers of the systems that manage digital records, want looser regulation. They contend that submitting to FDA safety reviews would slow the pace of innovation and make software upgrades difficult.

Before the administration releases its recommendations, the digital records industry and a group of sympathetic lawmakers in Congress are launching a preemptive strike, pushing legislation that would strip the Food and Drug Administration of its authority to regulate the software systems.

“Right now, the FDA has the authority to regulate all of health IT. They say they exercise discretion to pick and choose which technologies they regulate. From our perspective, that is just not a tenable state of affairs,” said Dan Haley, vice president for government and regulatory affairs for Athenahealth, a health information firm based in Watertown that is among firms leading the charge.


Although the administration has not said what it will do, the recommendations could lead to requirements for more safety monitoring of medical record systems and the public reporting of errors that harm patients.

But additional FDA oversight, industry representatives maintain, would add costs and stifle innovation.

Senator Angus King, a Maine independent, recently introduced legislation with Senator Deb Fischer, a Nebraska Republican, that would take away the FDA’s oversight of health and clinical software. A similar House bill, supported by Representative Niki Tsongas of Lowell, is also pending.

The proposed legislation would also prevent health software companies from being subject to the 2.3 percent tax charged to medical device companies as part of federal health reform. That tax went into effect last year but does not now apply to digital medical records.

Supporters of the legislation include Partners HealthCare, the parent company of Harvard teaching hospitals and affiliated medical groups, which is spending $1 billion to upgrade its digital health record systems.

King called his proposal to remove FDA oversight from digital health records simply an “attempt to codify common sense.”

“While blood-glucose monitors, pacemakers, and other high-risk devices must remain under the current FDA regulations, low-risk software like wellness apps and electronic health records need not be subject to burdensome regulations,” King said in a statement to the Globe.

An FDA spokeswoman said the agency would not comment on pending guidelines or legislation.


The looming battle is focused on a sector of health care technology that has long been painted in glowing terms. Moving from paper files to digital records, say advocates, will contribute to seamless decision-making by doctors, eliminate wasteful spending and redundant tests, and reduce errors.

The federal government has been fully on board with the push. President Obama’s 2009 economic stimulus bill included $36 billion for grants to help hospitals and doctors who purchase digital records systems. Massachusetts alone received more than $527 million in federal stimulus money promoting the adoption of digital health records.

In 2013, physicians and hospitals in the United States spent $36.2 million on health information technology, including digital medical records — up 9 percent since 2011, according to Gartner, an information technology research and advisory company based in Stamford, Conn.

The Massachusetts Technology Collaborative, a state economic development agency, estimates that the state’s health IT sector generated $8 billion in revenues in 2013, employing over 6,000 people at more than 200 firms.

But critics contend that increased public investment in the evolving medical records frontier should come with more accountability. And little is known about how frequently patients are harmed because of errors relating to these systems. Companies typically require hospitals to sign confidentiality clauses that prevent them from sharing information when something goes wrong, according to a federal study.

Some incidents are voluntarily reported to the FDA, but most criticism is based on anecdotes. Doctors have put in orders for the wrong patient. Computer screens displaying the wrong dates for medical tests result in mistreatment. Missing vital signs on a patient with kidney failure ended in death.


A 2011 report, done by the nonprofit Institute of Medicine and commissioned by the government, warned that poorly designed digital records could create hazards.

“Because the private sector has not taken substantive action on its own,” the report said, the Department of Health and Human Services should monitor safety and publicly report each year the progress being made. And unless the industry improves its record of safety monitoring and reporting, the report said, the Obama administration should direct the FDA to regulate digital medical records.

Dr. Richard I. Cook, a professor of health care system safety at the Royal Institute of Technology in Stockholm and a cowriter of the report, criticized his committee’s recommendations as not going far enough.

“The recommendations were very tame, very mild, but even those were too much for the manufacturers,” Cook said. “So now we’re in a situation where they are trying to set themselves aside and essentially fall outside of FDA regulation, to allow the software to be made more quickly, more profitably.”

Ross Koppel, a sociologist at the University of Pennsylvania who examines the impact of health care information technology on medication errors, criticized the legislation being proposed as “an attempt to allow vendors to be irresponsible and bear no consequences.”

The digital health records are not always easy to use and can require doctors to toggle between multiple computer screens to find basic information, such as patient allergies and medications, Koppel said.


The industry asserts that excessive regulation of software changes, for instance, could hinder the continuous software updates that are required to fix bugs.

“That would essentially kill the way we do business and kill our ability to continually improve our product for doctors and patients,” said Haley of Athenahealth.

Scott MacLean, deputy chief information officer at Partners HealthCare in Boston, said that the increased reliance on electronic medical records warrants scrutiny for errors but that the industry — not the FDA— is best positioned to police itself.

“The last thing I would want to do is roll something out that our clinicians would not trust,” MacLean said.

MacLean agreed there should be some oversight, just not to the same degree as medical devices traditionally regulated by the FDA.

As board chairman of the Healthcare Information and Management Systems Society, the industry’s trade association and lobbying arm, MacLean cowrote a letter to Secretary of Health and Human Services Kathleen Sebelius in November in an effort to influence the agency’s pending guidelines.

“It’s a somewhat adversarial environment, having to respond to FDA guidance all the time,’’ said Joe Ganley, director of state government affairs at McKesson Corp., a San Francisco health technology company with 650 employees in Massachusetts.

Tracy Jan can be reached at tjan@globe.com. Follow her on Twitter @GlobeTracyJan.