Regulation of Patient Safety Data Warehousing on the Horizon?
May 16, 2010
Posted by chcablogadmin in : Healthcare Reform, Quality
Conversations are heating up and policymakers are wrestling with how and whether to regulate health information technologies. Senator Chuck Grassley (R-Iowa) has become a very vocal proponent for stricter regulation. Last fall, he sent letters to IT vendors, asking about complications, errors and problems with health IT systems as well as disclosure; in January, he asked over 30 hospitals the same question, and in March, sent letters to HHS Secretary Kathleen Sebelius and H. Stephen Lieber, CEO of HIMSS, asking them to consider providing the FDA with more authority in this area.
In the past, CHCA has supported the Senator’s advocacy for full transparency in the drug industry and his stance against gag orders from medical device manufacturers. The Senator now proposes that IT vendors would be required to report adverse drug events and related signals of safety or quality through the use of these technologies. Adocates suggest encoding a notification button into HIT to capture and report misleading/confusing data and errors. I’m not sure how many of you read about this, but I took it to the logical next step. As hospitals work toward full CPOE implementation, regulatory intervention into patient safety data warehousing may become more prevalent. Equally concerning, recently passed Patient Safety Organization Legislation (PSO) which protects data from legal suits, would not likely protect it from governmental intervention.
Perhaps we need to work with our IT platform partners to put together regulations that truly could affect quality and safety in a more positive fashion.
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