; (D) an assessment of the ability of patients to obtain standard data from the devices they use, and the associated standards used to facilitate access to such data; and (E) an analysis of the cost burden on health care providers, the medical device industry, and other entities associated with the adoption of medical device interoperability standards; (2) recommendations to improve adoption of device interoperability standards, including any needed guidance, regulatory or statutory changes, or incentives for such adoption; and (3) a summary of recommendations or information submitted to the Secretary by stakeholders under subsection (c). (c) Stakeholder comment Not later than 180 days prior to the submission of the report under subsection (a), the Secretary, acting through the Commissioner of Food and Drugs, shall consult with representatives of regulated industry groups, patient groups, academia, and other interested parties to obtain recommendations or information relevant to the report.