We all know we're likely on the cusp of an explosion in health IT innovation (and maybe we're already there). Mobile devices and electronic health records already are transforming the way care is delivered, but they pose a host of new threats to patient safety and the security of health records.
With that in mind, three federal agencies — the Office of the National Coordinator for Health Information Technology, the Food and Drug Administration, and the Federal Communications Commission — recently released a draft report, highlighting ways to ensure health IT safety, while also not stifling innovation. Among their recommendations is the creation of a public-private "Health IT Safety Center" that brings together the various players in the equation, and promotes IT as an "integral part of patient safety."
Leaders from three agencies hosted a webinar last week, taking a few minutes to outline the particulars of the report and answer questions.
"The public and private sector must work together to develop a framework for safety, transparency, learning and continual improvement, and shared responsibility, with better defined accountability," says Jodi Daniel, director of the ONC's Office of Policy and Planning. "The Health IT Safety Center would serve as a trusted convener of health IT stakeholders, and identify governance structures, functions, etc., that are needed to create this sustainable, integrated health IT learning system."
Hospital leaders likely are already feeling barraged by requirements and regulations, between RAC auditors, meaningful use requirements and ICD-10 guidelines. Never fear, the report emphasizes that no new requirements or expectations are being proposed for hospitals or other affected parties, and no new rights are being created or conferred to any person. The report also highlights four key priority areas in developing a regulatory framework for health IT, including:
- promoting the use of quality management principles;
- identifying, developing and adopting standards and best practices;
- creating an environment of learning and continual improvement;
- leveraging the use of conformity assessment tools.
Such product testing, certification and accreditation could foster competition and innovation while assuring the safety of such health IT tools, says Matt Quinn, director of health care initiatives for the FCC. These assessments could be performed either by the government or the private sector, and the particulars won't be decided without "broad involvement of health IT stakeholders."
"Just about every developer and implementer of health IT, individually or in systems, is currently using conformity assessment with some level of rigor, even if the government doesn't say that you have to," Quinn says. "Conformity assessment is part of building a good product or having a smooth go-live, knowing that systems are safe, usable, secure, not going to cause wireless interference, going to operate as intended, etc."
The report follows months of discussions among the federal agencies and health IT experts, and its creation first was recommended in the FDA Safety and Innovation Act. In last week's webinar, leaders stressed that this is only a draft report, and interested parties will have 90 days to comment on it. The three agencies also plan to hold a public workshop on the report at a to-be-announced date in mid-May.
"This is a starting point and, as we have said in the past, this is a draft proposal for everybody in the community to react to and sort of help the agencies define these lines further," says Bakul Patel, senior policy adviser for the FDA's Center for Devices and Radiological Health.