Grassley Targets EHR Vendors

Last fall, Senator Charles Grassley sent letters to several EHR vendors, in which he asked them to respond to provider complaints about errors and complications associated with use of their products.

The complaints focused on interoperability problems, implementation snafus, usability issues and medical errors. In one case for example, "faulty software" calculated incorrect medication dosages by mistaking pounds for kilograms.

Allscripts-Misys, Cerner, Eclipsys, Epic Systems, McKesson and many other established EHR vendors received the poison darts.

Now the Iowa Republican has raised the issue again, this time by firing off a new fusillade at the providers themselves.

Grassley’s new missive asks providers to recount their experiences in contracting with EHR vendors, and how they analyze, track and report quality-related issues arising from use of the EHRs.

"Given the taxpayer investment and the investment of the health care system overall in the information technology industry, the more Congress and others overseeing implementation of this program dig into the problems and work to get them sorted out now, the better," Grassley said in a press release. "I look forward to hearing what (hospitals) have to say about expanded use of health care information technology."

Grassley expressed concern in particular with “gag order" provisions in vendor contracts that "prohibit health care providers and their facilities from sharing information outside of their facilities regarding product defects and other HIT product-related concerns."

He also expressed concern with “hold harmless” provisions that shift responsibility for errors produced by EHRs to the providers using them, even when providers use the EHR as they were intended to be used.

Hold harmless provisions rely on “learned intermediary" doctrine, which holds that medical experts are best positioned to sort through the risks and benefits of the activities they undertake. The corollary, EHR vendors suggest, is that since they do not practice medicine it is clinicians who are best positioned to identify errors resulting from application of EHR software.

Some of the providers in receipt of Grassley’s letter include Brigham & Women's Hospital, Cedars Sinai, Geisinger Medical Center, Intermountain Health, Kaiser Permanente, Mass General Hospital , Mayo Clinic and UCSF.

Our Take
Now that HITECH largesse seems destined to drive EHR vendor profits to new heights, the time is right for the Feds and/or the courts to re-examine gag order and hold harmless provisions in EHR vendor contracts.

EHR Vendors’ efforts to shift liability to users and prevent disclosure of defects in their systems may have been appropriate in the early days of the industry as a means to foster innovation, but they seem counterproductive and borderline unethical now that taxpayer dollars are being spent to foster EHR dissemination.

Such legal or regulatory changes will create proper incentives for EHR vendors to create error-free products, which would mean those learned intermediaries can focus on patient care rather than working around broken systems.

Glenn Laffel, MD, PhD
Sr. VP Clinical Affairs, Practice Fusion