Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “PROTECT Act Riposte.”
Following is an excerpt:
Electronic health record startup athenahealth Inc., a supporter of legislation that has been introduced in the House and Senate to restrict FDA oversight of health software, is circulating a written response to critics of the PROTECT and SOFTWARE Acts.
Some of the device and mobile app space argue that the pair of bills unwisely deregulates the health information technology sector with imprecise definitions and light enforcement regimes. ?…
“Substantial dependence” is a concept pushed by the Clinical Decision Support Coalition, run by Bradley Merrill Thompson; it tends to describe situations in which the user of a given software program is dependent upon its suggestions or decisions, due to lack of training, time or transparency.