Stakeholders urge a delay in federal oversight of IT and apps
June 22, 2013 in Medical Technology
A group of more than 100 health IT stakeholders sent a letter to the Obama Administration this week, cautioning the quick implementation of regulation for the industry.
The June 18 letter was signed by companies and organizations that include the College of Health Information Executives, the American College of Emergency Physicians, American College of Physician Executives, American Medical Group Association, American Medical Informatics Association, American Nurses Association. Companies including McKesson Corporation, Siemens Corporation, Greenway Medical Technologies and Microsoft were also signatories.
“While proper oversight of health IT is critical to ensuring patient safety, such oversight must be implemented in a balanced way that also fosters innovation and encourages adoption of these technologies,” the groups wrote.
[See also: FCC, FDA, ONC seek input on mHealth regs.]
The letter commended the administration for recently launching a workgroup in response to the Food and Drug Administration Safety Innovation Act of 2012. The FDASIA also calls for the Secretary of Health and Human Services to work with the Food and Drug Administration Commissioner, the National Coordinator for Health IT, and the Chairman of the Federal Communications Commission to send a report to Congress that contains a proposed strategy for regulation health IT and mobile technology.
The legislation is intended to help the government establish regulation that allows innovation, protects patients and avoids regulatory duplication.
“The thoughtful, comprehensive, and inclusive approach being taken by the administration to inform Congress will be critical as it develops this new regulatory framework for health IT,” the groups warned.
The letter called for the administration to allow ample time for the workgroup to complete its work before a federal agency guidance or policy be released associated with the regulation or oversight of health IT.
“We believe that, by working collaboratively, Congress and the Administration can produce a statutory framework for regulation of health IT based on risk while supporting innovation and patient safety,” the stakeholders wrote.