Government backs down on some requirements for digital medical records

Government regulators are backing down from many of their toughest requirements for doctors' and hospitals' use of digital medical records, just as Congress is stepping up its oversight of issues with the costly technology.

Doctors and hospitals need electronic health records (EHRs) to meet quality provisions of Obamacare.

EHRs are supposed to make things easier for doctors and consumers, who would have access to their own medical information. Digitizing records would allow doctors to exchange information about patients they share, which would improve quality and avoid duplication of tests and procedures.

Doctors and hospitals got $28 billion in federal stimulus money starting in 2011 to install EHR systems, also known as EMRs (electronic medical records). They were supposed to attest that they were using them to meaningfully improve patient care last year or lose some of their Medicare payments this year.

Now the Department of Health and Human Services is proposing a series of revisions to its rules that would give doctors, hospitals and tech companies more time to meet electronic record requirements and would address a variety of other complaints from health care professionals.

"The problem is we're in the EHR 1.0 stage. They're not good yet," says Terry Fairbanks, a physician who directs MedStar's National Center for Human Factors in Healthcare. The federal government "missed a critical step. They spent billions of dollars to finance the implementation of flawed software."

These digitized records remain the bane of many doctor and patient relationships, as physicians stare at computer screens during consultations.And there's the issue of time. University of Chicago Medicine anesthesiologist William McDade, who has switched from paper to electronic records, says that while EHRs put information at doctors' fingertips, those doctors must take extra time to enter data, and some systems are not intuitive.

Praveen Arla of Bullitt County Family Practitioners in Kentucky says even though he's "one of the most tech-savvy people you're ever going to meet," his practice has struggled mightily with its system. It cost hundreds of thousands of dollars to put into place, he says, and it doesn't even connect with other systems in hospitals and elsewhere.

The federal government "should've really looked at this more closely when EMRs were implemented. Now, you have a patchwork of EMR systems. There's zero communication between EMR systems," he says. "I am really glad they're trying to look back and slow this down."

Other issues:

• Reliability. Crashes are becoming more common. MedStar in Washington, D.C., and Baltimore had to take down their electronic health record system for 160 primary care doctors' offices and urgent care centers for about three days last month to avoid a crash, says spokeswoman Ann Nickels. Patient records were available in read-only mode, and doctors and nurses were told to switch over to paper records.

• Safety. Physician Robert Wachter, author of The Digital Doctor, is a proponent of,EHRs, but sounded several cautionary notes in his book about the problems. At the University of California San Francisco, where he chairs the department of medicine, a teenage patient nearly died of a grand mal seizure after getting 39 times the dose of an antibiotic because of an EHR-related issue. But Wachter says he believes patients are safer with EHRs than they were with paper.

• Liability. If electronic records are not used correctly, they can increase the risk of errors, malpractice and lawsuits, says Susan Kressly, medical director of Office Practicum, a Pennsylvania-based electronic health records company geared toward pediatricians. Although systems give electronic warnings about medication allergies, if doctors don't put the prescribed medication in the right place in the record, the warning may not pop up, she says.

Some proponents of EHRs say the government has been thwarting efforts to improve them. In addition to extending the deadline for implementing EHR requirements, a series of HHS proposed rules extends the time doctors, hospitals and tech companies have to meet EHR requirements, cuts how much data doctors and hospitals have to collect and reduces how many patients have to access to their own electronic records from 5% of all their patients to just one person.

"That is a slap in the face to patient rights and all the advocates because we worked so hard and for so long to ensure patients could access their data," says patient advocate Regina Holliday.

Holliday became an electronic records advocate after her husband died of kidney cancer in 2009 at age 39. His care was adversely affected because hospitals weren't reading his earlier EHRs and she had trouble getting access to the records.

EHRs "have made our lives harder" without improving safety, says Jean Ross, co-president of National Nurses United. Last year, the nurses' union called on the Food and Drug Administration "to enact much tougher oversight and public protections" on EHR use.

Meanwhile, the medical industry is urging HHS to give them even more time and flexibility to improve their systems,

"The level of federal involvement and prescriptiveness now is unhealthy," says Wachter, who chairs the UCSF department of medicine. "It has skewed the marketplace so vendors are spending too much time meeting federal regulations rather than innovating."

Sen. Lamar Alexander, R-Tenn., chairman of the Senate health committee, and Sen. Patty Murray, D-Wash., announced a bipartisan electronic health records working group late last month to help doctors and hospitals improve quality, safety and privacy and facilitate electronic record exchange among health care providers and different EHR vendors.

"It's a great idea, it holds promise, but it's not working the way it is supposed to," Alexander said of EHRs at a recent committee hearing.

At a Senate appropriations subcommittee meeting last month, Alexander told HHS Secretary Sylvia Burwell that he wanted EHR issues at the top of his committee and HHS' priority list to be addressed through regulation or legislation.

Burwell agreed and called the issue "extremely important."

Jonathan Bush, CEO of Athenahealth, which has about 4% of the EHR market, has been an outspoken opponent of the federal stimulus money and regulations for EHRs.

"I do believe 'federal innovation' is somewhat of a contradiction in terms," Bush says. Over-regulation "actually has unintended consequences, killing the soul of the industry."

Minnesota lawmakers became the latest state this week to allow health care providers to opt out of using EHRs. But MedStar's Fairbanks says doctors would welcome well-designed, intuitive EHRs that made their jobs easier instead of more difficult — and that would improve safety for patients, too.