The critical factor in determining the risk posed by different types of clinical decision support (CDS) software is whether that support “is mediated by a human being,” stated AMIA in a comment letter sent to the FDA, which is preparing draft guidance on mobile medical applications. The FDA’s most rigorous attention, AMIA advised, should be […]
Safety concerns took center stage at the HIT Policy Committee meeting today in Washington, D.C., as Certification and Adoption Workgroup Co-chairs Paul Egerman and Marc Probst reported their recommendations on those issues to the full committee. The workgroup’s report was a refinement on an earlier presentation Egerman, a software entrepreneur, and Probst, CIO at Utah-based Intermountain Healthcare, gave after receiving testimony about HIT-related patient safety incidents on Feb. 25.
The merits of working with the FDA to help ONC craft an EMR certification program that addresses both pre- and post-market HIT patient safety issues were discussed at the HIT Policy Committee Workgroup on Certification and Adoption meeting held this week. On one side of the debate, HIT Software Entrepreneur and Workgroup Co-Chair Paul Egerman argued that the FDA could bring some significant value to the table in crafting a program.
“The FDA considers both unwanted harmful effects and lack of efficacy to be adverse events. When considering candidates for pharmacogenomic relabeling, the FDA evaluates the severity of the adverse reaction, the degree to which genetics predicts the reaction, and the total number of individuals likely to be affected. These factors are important in assessing the […]