In an extensive set of pledges on patient safety, the longest section in the code, vendors would “recognize the value of our customers' participation in discussions about patient safety. We will not contractually limit our customers from discussing patient-safety issues in appropriate venues” while maintaining “fair and reasonable intellectual property protections.”
The clause addresses concerns raised as long as three years ago when Sen. Charles Grassley (R-Iowa) began an investigation into alleged “gag clauses” in EHR contracts that may have chilled discussions and sharing of information among providers about flaws in EHR systems that led to patient safety problems.
The code also includes a provision that seeks to address an issue called “vendor lock-in” that has long plagued the health IT industry, at least from a software user's perspective. Lock-in occurs when a hospital or physicians' group is reluctant to switch from its current EHR because the data it stores in proprietary formats cannot readily be copied and transferred to another vendors' system.
Adherents to the new code of conduct would pledge that they will allow customers to “exchange clinical information with other parties, including those using other EHR systems, through standards-based technology, to the greatest extent possible.”
There will be no charges or fees levied by the association on any vendor pledging adherence to the code, nor does release of the code today automatically constitute endorsement of it by EHRA members, said Michele “Mickey” McGlynn, chair of the association and senior director of strategy and operations at Siemens Healthcare. “Adoption of the code is up to each individual company,” she said, and the association “encourages all members and nonmembers to adopt the code” and promote its adoption.
The association will not keep a central repository of those companies who do take the pledge, but it will enable vendors to use a logo it has developed for the code and allow them to link to its Web page where the code documents are maintained, she said.
The federal government is exploring the possibility of erecting a new regulatory framework to ensure the safety of health information technology.
Late last month, the Office of the National Coordinator for Health Information Technology at HHS published a formal request for input as they prepare a report mandated by the Food and Drug Administration Safety and Innovation Act of 2012.
In 2011, the Institute of Medicine report found “unacceptable risks” posed by health IT systems. Among the multiple barriers to the gathering of risk information cited were the nondisclosure and confidentiality clauses in the contracts between health IT vendors and providers “that can prevent users from sharing information about health IT-related adverse effects.” The ONC and the FDA are expected to deliver recommendations this summer “for an appropriate, risk-based regulatory framework” in response to the IOM's conclusions.
ONC Chief Dr. Farzad Mostashari, who attended the news conference, praised the EHR vendor association for attempting to address patient safety in the code. Mostashari asked whether the adoption of the code by a vendor would create an obligation enforceable by the Federal Trade Commission.
McGlynn responded that the association had not explored that issue. In a subsequent telephone interview, EHRA spokeswoman Elizabeth West said that's a possibility. If a customer feels a vendor misrepresented itself, West said, filing a complaint with the FTC “might be the appropriate path to pursue, just as anybody would have dealing with a company that makes false claims.”
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