The Healthcare Information and Management Systems Society (HIMSS) this week submitted comments on a new regulatory scheme proposed for healthcare IT software.
The Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT Report proposes a three-tiered regulatory framework that features risk-based categorization and regulation of HIT software, as well as a number of nonregulatory initiatives designed to improve HIT.
HIMSS offered comments on each of the proposed three categories, and it noted that a potential fourth category could be incorporated to include pharmacy, diagnostics, and procedural health IT functions, with areas of focus to include medication management, radiology, labs, and surgery.
HIMSS also agreed that a health IT safety center should operate within the scope outlined in the draft report and not as a regulatory or oversight body. The safety center should focus on gaining evidence and knowledge without specific implementation responsibility, according to the society.
"We suggest that the center should operate transparently, with clear roles for public and private-sector participants, open meetings, and potential opportunities to review drafts of policies," HIMSS stated in its comments.
To view the FDASIA report, click here.
