|
Overview
FDA has initiated a process to develop a guidance document to define those types of clinical decision support (CDS) software that the Agency will regulate. FDA kicked-off that initiative with a hearing in September 2011 and is now actively working on drafting guidance. We expect to see the draft guidance published sometime in early 2012. For more background, please read the article “Is FDA’s EHR Exemption Becoming Extinct?”
The mission of the CDS Coalition is to work with FDA and international regulatory bodies to ensure that software used to support clinical decision-making does not become overregulated.
Our membership consists of all those who want to make or use software to improve the quality of healthcare. We encourage all stakeholders to participate, including:
- Software vendors
- Healthcare payors
- Hospitals and other providers
- Medical device manufacturers
- Existing trade groups
- Members of the clinical community and others who represent patients and professional groups (e.g., clinical societies).
Broadly speaking, the coalition would develop answers to two basic questions:
- What types of CDS software should be regulated?
- For those types of CDS software that are regulated, to what level should they be regulated?
Resolving these broad issues of what types of CDS software should be regulated will also require more detailed analysis in at least the following six areas:
- The impact of competent human intervention on the scope of what gets regulated
- The data input process
- The types of data manipulation and mining that qualify for regulation
- The types of information output that should be regulated
- The types of intended uses that should be regulated
- The freedom of end users to tailor software to their individual needs without regulatory oversight
Dec. 28, 2011 – FierceHealthIT Publishes Article on FDA's Approach to Regulation of CDS Software
As 2011 comes to a close, the folks at FierceHealthIT have published a brief summary of the FDA's approach to regulation of CDS Software. This is a helpful primer for anyone who develops CDS software, especially those who are not familiar with the FDA.
Nov. 14, 2011 – The Gray Sheet Interviews Brad Thompson on FDA Regulation of CDS Software
The Gray Sheet published an interview with Brad Thompson, discussing FDA regulation of clinical decision support software and the CDS Coalition. A reprint of the interview is available here.
Nov. 10, 2011 – IOM Issues Report Calling for New Agency for HealthIT
The Institute of Medicine issued a report today on HealthIT and patient safety, calling for a new agency rather than the FDA as the agency responsible for regulatory oversight. Read the press release here. Download the full report here.
Nov. 9, 2011 – iHealth Alliance and HIMSS’ EHRA Announce Collaboration to Reduce Medical Errors
The iHealth Alliance—a non-profit with the mission to protect the interests of patients and providers with respect to the use of electronic systems in patient care—and the EHR Association (part of the Health Information and Management Systems Society) announced a collaborative effort “to develop practical, effective, and optimized reporting tools to collect information on medical incidents that may be related to the use of health information technology.” Read the press release here.
Nov. 8, 2011 – Announcing the CDS Coalition Formation
The CDS Coalition is in the early stages of formation. If you are interested in joining or would like additional information, please contact Brad Thompson or Jason Brooke.
The near-term plan moving forward is the following:
- Introductory call: We will hold a one-hour call on Tuesday, November 15 at 11AM (Eastern time) to engage interested participants and to describe the background, the mission, and objectives of the Coalition. We will collect input and ideas from this group discussion as well.
- In-person, organizational meeting: This meeting will take place in Washington DC on December 6 (9:30 a.m. to 12:00 p.m.)—a date when many folks involved in mHealth will be in Washington for a large NIH Foundation meeting. The purpose of the Coalition meeting will be two-fold: (1) to make some reasonably final decisions regarding the scope and mission of the organization, and (2) to establish the basic parameters for membership and operations, including dues and governance. We have a very simple model that has worked quite well for other coalitions that we will put on the table for consideration.
- Recruiting period: Between December 7 and January 1, we will ask companies to evaluate whether or not they wish to participate in the coalition.
- Operational call: On Wednesday, January 4 at 11AM (Eastern time), we will have the first operational call of the Coalition (members only), during which we will start to develop whatever work product the Coalition decides upon, and organize the government affairs activities to advance the consensus position.
|