Sen. Charles Grassley (R-Iowa), ranking member of the Finance Committee, is investigating reports he has received that EHRs and computerized physician order entry systems are plagued with flaws that can result in patient or financial harm. The investigations is being conducted as federal officials implement provisions of the American Recovery and Reinvestment Act that will make tens of billions of dollars available to providers to significantly increase the adoption and use of EHRs.
That investigation took a sharp turn in late February when Grassley sent signals (see sidebar, page 30) that he might be considering Food and Drug Administration regulation of clinical information systems. Grassley, in letters sent to Health and Human Services Secretary Kathleen Sebelius, and the influential Healthcare Information and Management Systems Society trade association, asked for their views on a 1997 position paper that called for voluntary industry oversight of the integrity of clinical systems rather than regulation (see sidebar, page 30). The paper was published in the Journal of the AmericanMedical Informatics Association. The FDA, which started considering regulation in 1996, ultimately declined to do so amid industry opposition.
Grassley's also concerned with contractual "hold harmless" provisions that absolve vendors of responsibility for harm, and "gag orders" more commonly known as confidentiality or nondisclosure provisions that prohibit providers from publicly disclosing problems with their software. It should be noted that various types of confidentiality and hold harmless clauses are in virtually all I.T. contracts in all industries, consultants and attorneys who negotiate these contracts say. Grassley, however, wants to know if these clauses can be worded in a way that potentially could jeopardize patient safety.
Grassley last October sent letters to 10 health information technology vendors-half of whom do not sell EHR systems. "Over the past year, I have received complaints from patients, medical practitioners and technology engineers regarding difficulties they have encountered with the HIT and CPOE devices in their medical facilities," the letter read. "These complaints include, for example, faulty software that miscalculated intracranial pressures and interchanged kilograms and pounds, resulting in incorrect medication dosages."
In the letter, Grassley asked for specific information on how vendors handled complaints about their products, whether their contracts had "hold harmless" or confidentiality clauses, whether providers received payments or discounts for promoting the vendor's products, and whether they had settled lawsuits related to EHR and CPOE products in the past 18 months.
Grassley, as a Finance Committee member, has control over funds authorized in the American Recovery and Reinvestment Act, which include Medicare and Medicaid incentive payments for meaningful use of electronic health records. In January, he sent letters to 31 hospitals or delivery systems, but no independent physician practices, asking similar questions. "Over the past several months ... I have been made increasingly aware of difficulties and challenges associated with HIT implementation," the letter stated. "The reported problems appear to be associated with administrative complications in implementation, formatting and usability issues, and actual computer errors stemming from the programs themselves, as well as, interoperability between programs."
So the questions put on the table by Grassley: Are electronic health records systems sold in the United States unsafe? And are the products pushed by vendors who protect themselves with draconian provisions in EHR contracts?
Industry insiders say there are indications Grassley's interest was fueled by a commentary critical of vendor contractual provisions that was published in March 2009 in the Journal of the American Medical Association. Providers, attorneys and consultants interviewed for this story declined to share specific contractual clauses in signed contracts, citing the proprietary nature of the clauses.
In that JAMA article, co-authors Ross Koppel, PhD., and David Kreda charged that health I.T. vendors are "virtually liability free" if their products cause harm and provisions in many contracts prohibit customers from disclosing software attributes, even to other organizations using the same software. Further, a provider that signs a contract with a blanket hold harmless clause would have a very high legal barrier to challenge that clause later, Koppel said in an interview with HDM. "There is a system that reduces the level of exposure to the public."
Koppel is a sociology professor and a principal investigator in the Center for Epidemiology and Biostatistics in the University of Pennsylvania School of Medicine. Kreda is a software designer at The Social Research Corp. in Wyncote, Penn.
But the reasons for Grassley's inquiry and the answers to the questions he poses aren't clear. And the senator isn't explaining himself: After HDM asked for an interview, Grassley's office indicated questions sent via e-mail would be answered in writing. When the office didn't reply after questions were submitted, HDM made two follow-up inquiries and received no response from the senator's office.
The 10 I.T. vendors receiving Grassley's October letter were: Allscripts, Cerner Corp., Eclipsys Corp., Epic Systems Corp., McKesson Corp., 3M Health Information Systems, Cognizant, Computer Sciences Corp., Perot Systems and Philips Healthcare. Most declined to comment about the letter for this article.
The first five are EHR vendors, and multiple sources for this story say they likely are being queried by Grassley by virtue of being major players in the EHR market. It's unclear, since Grassley specifically is investigating EHRs, why the last five vendors on the list received the letter. But a spokesperson for Cognizant says that Grassley's office told her the company received the letter after its name came up on an Internet search by office staffers for health I.T. vendors.
HDM also requested interviews with a number of provider organizations that received Grassley's letter. Four organizations-Geisinger Medical Center in Danville, Pa., Intermountain Healthcare in Salt Lake City, Marshfield (Wis.) Clinic and University of Pennsylvania Health System in Philadelphia-agreed to comment.
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