Health IT Now (HITN) appreciates the opportunity to comment on the draft guidance entitled Clinical and Patient Decision Support Software. HITN is a diverse coalition of health care providers, patient advocates, consumers, employers, and payers who support the adoption and use of health IT to improve health outcomes and lower costs.
HITN is a strong supporter of a risk-based regulatory framework for health software and worked diligently with stakeholders and policymakers to help craft the language in Section 3060 of the 21st Century Cures Act. We believe that the draft guidance is aligned with Congressional intent and appropriately adopts the risk-based framework called for in the law for clinical decision support software.
We are, however, concerned with lines 228-231 of the draft guidance, which establishes that a practitioner would be unable to independently evaluate the basis of a recommendation if the recommendation were based on non-public information. Sec. 3060(1)(E)(iii) of Cures states that health software that enables a health care professional to “independently review the basis for such recommendations that such software presents” shall not be included in the definition of a medical device under the Food, Drug, and Cosmetic Act. With this language, Congress intended to prohibit the exclusion of so-called “black box” software that does not provide transparency in the data that goes into software algorithms. They did not intend to establish a bar that the data must be publicly available. We request that the FDA amend this language to reflect that the information should be available to the healthcare professional instead of publicly available.