Senators voice concern about FDA’s Pre-Cert program
Three Democratic senators are voicing concerns about the Food and Drug Administration’s Software Pre-Certification program, arguing that the agency is working outside the boundaries of its statutory authority.
In a letter to FDA Commissioner Scott Gottlieb, M.D., Sens. Elizabeth Warren, D-Mass., Patty Murray, D-Wash., and Tina Smith, D-Minn., outlined a series of questions focused on how exactly the agency plans to give software developers more flexibility and whether companies would be required to renew their precertification clearance.
The lawmakers said they support the program but remain focused on ensuring it does not negatively impact public health.
“The agency should be focused on ensuring it has the tools and capacity to guarantee that software products that perform medical device functions are safe and effective and to hold companies that skirt the rules accountable,” they wrote. “Instead, the Pre-Cert Pilot focuses heavily on the potential of standards for design, validation, and maintenance of software and the ability to capture post-market data to reduce premarket review time or eliminate the need for premarket review all together.” (Letter—PDF)
VA and DOD sign joint commitment on EHR modernization
The Department of Veterans Affairs and the Department of Defense (DOD) issued a signed joint commitment to implementing a “single, seamlessly integrated EHR” on Wednesday.
Defense Secretary James N. Mattis and VA Secretary Robert Wilkie said they would “institute an optimal organizational design that prioritizes accountability and effectiveness, while continuing to advance unity, synergy, and efficiencies between our two Departments.”
They added that the importance and financial investment of EHR modernization efforts demand more synergy across the two agencies. Wilkie said the joint statement provides “tangible evidence” of their commitment to providing “Veteran-focused” care. (Joint Commitment—PDF)
Researchers advocate expanding EHR e-triggers
A new study published in BMJ Quality & Safety argues that e-triggers built into EHRs to notify clinicians about potential medication errors could be used to detect diagnostic events.
The authors outline a framework for hospitals to use “Safer Dx Trigger Tools” by monitoring patient events and allowing providers to initiate proactive measures. For example, a patient that shows up to the ED days after a clinic visit could suffer from a missed diagnosis.
“Certain e-trigger tools can additionally monitor for high-risk situations prospectively, such as when risk of harm is high, even if no harm has yet occurred,” the researchers wrote, adding that diagnostic triggers will require larger hospital investments. (Study)
Consumers open to unique IDs, biometrics to resolve patient matching
Although most consumers are unaware of the issues around patient matching, most were open to solutions like biometrics and unique patient identifiers to resolve any potential confusion, according to a series of focus groups by Pew Charitable Trusts.
Consumers were often concerned about privacy and security around certain solutions and seemed to favor biometrics. Although some liked the idea of a smartphone app that would reduce redundant paperwork, many worried that it wouldn’t be accessible to low-income patients or elderly patients with less smartphone experience. (Issue brief)
Former OCR deputy director blasts medical record roadblocks
After leaving her post as deputy director at the HHS Office for Civil Rights (OCR) for the Silicon Valley startup Ciitizen focused on getting patients access to their medical records, Deven McGraw says she was “ready to hit the ground running, … and then reality punched me hard in the stomach.”
Despite OCR’s 2016 HIPAA, which McGraw helped author, “getting your medical records today doesn’t seem to be much better,” she wrote in a blog post. Ciitizen has been working to collect information from hospitals, labs and physicians, but keeps running up against resistance.
“The obstacles we are confronting make my blood boil—especially because I know so many of the roadblocks are flat-out failures to comply with the HIPAA regulations,” she wrote. (Blog post)