The Food and Drug Administration has proposed a streamlined, risk-based framework that medical device and information technology application developers can follow without the long lead times that typically come with agency approval amid a growing healthcare IT industry, FCW reported Monday.
Adam Mazmanian writes this new approach to health IT is contained in an FDA Safety and Innovation Act report published in April 2014 following consultations with the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology.
Per the report, the idea is to jumpstart the development of health IT products while still regulating areas that impact patient safety and health such as device functionality of bedside monitor alarms, computer-aided detection software and robotic surgical systems.
The recommended approach focuses on health management health IT functionalities, including health information and data exchanges, medication management, knowledge management, and patient identification and matching.
“The agencies recognize the importance of health IT to our nation’s health as well as the significance stakeholder input will play in the development of a risk-based framework for health IT that promotes innovation, protects patient safety and avoids regulatory duplication,” the agencies say in the report.
In particular, they urge industry stakeholders and private-public partnerships to take part in creating a set of processes that would validate an IT system or device’s safety, interoperability and performance.