Fred Schulte, Kaiser Health News and Erika Fry, Fortune
[UPDATED at 2 p.m. ET on March 26]
The chairman of the Senate well being committee on Tuesday backed new federal laws to take away roadblocks sufferers can face in acquiring copies of their digital medical data.
“These proposed rules remove barriers and should make it easier for patients to more quickly access, use and understand their personal medical information,” Lamar Alexander (R-Tenn.), chairman of the Health, Education, Labor & Pensions Committee, stated in an announcement ready for a listening to on the principles that kicked off Tuesday at 10 a.m.
The guidelines, proposed final month by the Department of Health and Human Services, take purpose at so-called data blocking, wherein tech corporations or well being methods restrict the sharing or switch of knowledge from medical information.
Alexander stated HHS believes the brand new guidelines ought to give greater than 125 million sufferers simpler entry to their very own data in an digital format.
“This will be a huge relief to any of us who have spent hours tracking down paper copies of our records and carting them back and forth to different doctors’ offices. The rules will reduce the administrative burden on doctors so they can spend more time with patients,” Alexander stated.
The proposal requires producers to trend software program that may readily export a affected person’s total medical report — and mandates that well being care methods present these data electronically for free of charge to the affected person.
Congress jump-started the nation’s change from paper to digital well being data in 2009 utilizing billions of in monetary stimulus funding to assist medical doctors and hospital buy the gear. Officials anticipated the shift to chop down on medical errors, scale back pointless medical testing and different waste and provides Americans a much bigger function in managing their well being care.
Yet within the decade because the rollout, critics have argued that the federal government spent billions financing software program that may trigger some new sorts of errors and sometimes can’t share data throughout well being networks as meant.
“Botched Operation,” a latest investigation revealed by KHN and Fortune, discovered that the federal authorities has spent greater than $36 billion on the initiative. During that point, hundreds of experiences of deaths, accidents and close to misses linked to digital methods have piled up in databases — whereas many sufferers have reported difficulties getting copies of their full digital information.
Sen. Patty Murray (D-Wash.), rating member on the committee, cited two sufferers profiled within the article as an example the potential risks from EHRs that may’t trade data.
“It’s patients who get hurt. Like the man in California, who suffered brain damage after his diagnosis was delayed because a hospital’s software couldn’t properly interface with a lab’s software,” she stated on the listening to. “Or the woman in Vermont, who died of a brain aneurysm that might have been caught if a software problem hadn’t stopped the order for a test she needed.”
Jonathan Lomurro, a medical malpractice lawyer in New Jersey, stated his purchasers normally should go to court docket to get their full medical report. The data that well being care suppliers combat most bitterly to maintain from them, he stated, are the audit logs — or the info that present each time a report has been accessed or edited, and by whom and when.
That “metadata,” he and different plaintiff attorneys argue, is vital for sufferers to grasp the historical past of their care, significantly in circumstances the place one thing has gone unsuitable.
In an interview previous to Tuesday’s listening to, Lomurro criticized the HHS proposal, saying it limits a affected person’s potential to acquire these logs. While the proposed rule requires the methods to share most information from a medical report with a affected person, it excludes audit trails from that classification.
“While the proposal talks about the need of patient access … they then strip the greatest protections from the patient,” stated Lomurro. “I am at a loss on how this could ever be a beneficial change to the rules and help patients.”
Seema Verma, who heads the Centers for Medicare & Medicaid Services, agreed that sufferers must be entitled to audit log data. “At the end of the day, it’s all of the patient’s data. If it affects and touches their medical record, then that belongs to them,” Verma stated in an interview final month.
The HHS proposal additionally encourages medical doctors and different customers of EHR know-how to share details about software program issues they encounter by prohibiting “gag clauses” in gross sales contracts. Critics have lengthy argued that the clauses have prevented customers from freely discussing flaws, together with software program glitches and different breakdowns that would lead to medical errors and affected person accidents. In 2012, an Institute of Medicine report blamed the confidentiality clauses for impeding efforts to enhance the security of well being data know-how.
But a serious remaining drawback in wiring up medication is the dearth of interoperability throughout rival information methods, stated Christopher Rehm, chief medical informatics officer of LifePoint Health, a hospital system in Brentwood, Tenn. In testimony ready for the Tuesday listening to, Rehm known as it “the equivalent of telling people they must buy cars and move those cars from place to place, but there are no roads and no agreed-upon design for the roads, let alone the funding to actually pay for the construction.”
According to Rehm, the average-sized neighborhood hospital (161 beds) spends almost $760,000 a yr on data know-how investments wanted to satisfy federal laws. He stated the prices “are crushing our industry where margins are already thin.”
Kaiser Health News (KHN) is a nationwide well being coverage information service. It is an editorially impartial program of the Henry J. Kaiser Family Foundation which isn’t affiliated with Kaiser Permanente.