Grassley in late February sent letters to Health and Human Services Secretary Kathleen Sebelius, and H. Stephen Lieber, CEO at the Healthcare Information Management and Systems Society, asking for the organizations' views on a 1997 position paper that called for voluntary industry oversight of the integrity of clinical systems rather than regulation.
The paper was published in the Journal of the American Medical Informatics Association. The paper, which included definitions of proposed risk categories of clinical systems and classes of regulation, concluded that clinical software did not meet standards for regulation.
The FDA, which started considering regulation in 1996, ultimately declined to do so amid industry opposition.
One of the questions Grassley asks of Sebelius, is: "With over $20 billion in taxpayer money at stake and with increasing complexity in the technologies being used in our hospitals, do you believe it is time to revisit FDA's responsibilities in regulating HIT products being used in clinical care?" FDA is an agency within HHS. Officials were not immediately available for comment.
Among the questions to HIMSS: What is HIMSS' position on FDA's current role in the regulation of HIT products? Would you support providing FDA with more authority in this area? Is there another agency that should be given authority to regulate the safety of HIT products? HIMSS does not presently have a position on FDA regulation.
Grassley has considerable legislative clout as the ranking member-the leading Republican-on the Finance Committee. Last October, he sent letters to 10 health I.T. vendors asking how they handle complaints of faulty software and whether clauses in their contracts prohibit providers from discussing flaws with third parties, or shield vendors from liability for harm that results from the use of I.T.
Grassley sent a similar letter in January to 31 hospitals or delivery systems.
HIMSS received a letter from Grassley because the Center for Health Information Management, a trade association, contributed to the 1997 position paper before its 2001 merger with HIMSS but did not fully support all positions in the paper, says Carla Smith, former leader of CHIM and now executive vice president at HIMSS.
One of the recommendations in lieu of regulation was creation of local clinical oversight committees. Smith acknowledges the industry did not follow through on proposals outlined in the 1997 paper, including oversight committees. Asked why, she responds, "My guess is that the FDA ceased its inquiry."
The industry did ignore its own proposals outlined in 1997 after the FDA stopped considering regulation, says a leading member of the American Medical Informatics Association, who requested anonymity. The AMIA played a role in developing the position paper.
At the same time, however, the FDA's budget during the past decade was steadily cut and it doesn't have the resources to adequately regulate, the source contends. "FDA has all the data on regulated medical devices but not the resources to analyze it. When devices fail, FDA already has that data."
The industry is evenly divided four ways on regulation, according to the AMIA source. The camps include those who believe in no regulation, light regulation, heavy regulation and self-regulation. And now there's scrambling to figure out what to do. "We've been overtaken by events."
In recent written testimony before a workgroup of the HIT Policy Committee, AMIA CEO Ted Shortliffe, M.D., acknowledged increasing complexity of electronic health records and other health I.T. systems, "with roles in patient care decision making that have demonstrated potential risks to patients and to optimal care, even when the system is not explicitly offering decision support."
Shortliffe, who was not available for comment, noted in his testimony that AMIA in late 2009 appointed a task force to study ethical and safety issues of clinical products and vendor-supplied systems.
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