Joining the Health IT Regulation Debate

June 3, 2014

The Food and Drug Administration (FDA) recently released an important report that will impact how digital health is regulated in the future. The Safety and Administration Act (FDASIA) Health Information Technology Report describes a proposed strategy and recommendations for a health information technology (Health IT) regulatory framework. For many of us involved in digital health, it has become important to listen, as well as to be a part of, the conversation regarding how to achieve a healthy balance between innovation and patient safety. Developing and implementing this proposed framework is challenging and complex-- requiring feedback from key stakeholders in the Health IT arena.

A few weeks ago we “listened in” to this feedback gathered during a three-day public workshop commissioned by the FDA, the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission. The FDASIA instructs these groups to promote innovation, protect patient safety, and avoid regulatory duplication. The workshop accomplished a number of great things for Health IT, including:

  • Gathering opinion on a risk-based approach that focuses on software function, rather than platform or device
  • Exploring ways to promote quality management and best practices without sacrificing accountability across the technology industry and its users (including hospitals, providers and patients)
  • Discussing what types of conformity assessment tools will be incorporated into the framework to ensure product quality and safety
  • Defining operability issues between devices with a focus on what will be tested, by whom, and to what extent
  • Examining the best ways to ensure reporting and analysis of safety data, as well as where the data will be housed and what agency will conduct surveillance
  • Outlining the role of the proposed Health IT Safety Center in sharing education and best practice information to relevant stakeholders

From our perspective, one of the key take-away messages is that although defining regulatory policies for Health IT is difficult – it is necessary. As the field continues to evolve, we need to protect the growing number of healthcare providers and patients using these products. Flexibility in regulatory oversight will be essential to allow for changes in the Health IT environment.

It’s important for us all to better understand the issues and engage in the conversation. So, what are your thoughts about the regulation of Health IT? Public comments on the proposed Health IT regulatory framework are being accepted by the FDA through July 7th.  (Click here to download the report.) We encourage you to learn more and voice your opinion on this critical issue in digital health. (Click here to share your thoughts.)