ITAC Health is advising its members that Health Canada will be issuing a revised definition for “Patient Management Software” with respect to medical device licensing. According to ITAC Health, the new definition will be less restrictive than the definition contained in Health Canada’s 21 May 2010 notice on this subject. An FAQ addressing this matter is expected from Health Canada before the end of November.
Further my blog post yesterday, I note that the US Institute of Medicine (IOM) was recently awarded $1M by the Department of Health and Human Services (HHS) to conduct a one year study to ensure that health IT will “achieve its full potential for improving patient safety in health care”. According the HHS news release, “the study will examine a comprehensive range of patient safety-related issues, including prevention of HIT-related errors and rapid reporting of any HIT-related patient safety issues.”
Given the Canadian debate regarding Health Canada regulations and their impact on patient safety issues, I was intrigued to note that study will include “discussion of existing authorities and potential roles for key federal agencies, including the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality (AHRQ), and the Centers for Medicare & Medicaid Services (CMS)”. Perhaps we need a similar study in Canada to address concerns raised regarding Health Canada regulations.
I have been following the debate regarding Health Canada regulation of HIT software (including physician EMR software) and have written several blog posts on this topic. While the Canadian debate seems to have taken place after the regulations were put in place and decisions made to actively enforce them, the US debate is taking place BEFORE decisions regarding how best to regulate health IT for patient safety are made.
As it does for many issues facing the health IT industry, HIMSS is seeking input from the community on how best “to foster a large scale dialogue on the issue”. In a recent blog post (HIMSS actively engages its members and the broader community through blogs and other social media), HIMSS summarizes the current situation in the US and poses the question “What should be the role of the federal government in ensuring the patient safety of health IT products and the settings in which they are utilized?”
Do we need a similar debate in Canada or is the matter already decided? I fear that much of the debate in Canada is taking place behind closed doors and that there is little opportunity for input from the broader stakeholder community.
Just under two weeks agoI attended and blogged about a workshop on the Health Canada medical device regulations hosted by ITAC Health, MEDEC, and COACH. This workshop explored the applicability of these regulations to health IT software. Since that workshop I have learned that various stakeholders have different views on the extent to which the Health Canada regulations should apply to health IT software.
The HIT vendor community appears to support application of the Health Canada regulations to HIT software. On 7 September 2010 ITAC Health published a blog post summarizing their position on the Health Canada regulations. This post states that “ITAC Health supports the application of Health Canada’s Medical Device Regulations (MDR) as they apply to patient management software defined in Health Canada’s Notice dated May 21, 2010. This regulation is appropriate for patient management software products that manipulate and interpret clinical data, which require a high standard of quality.”
According to a comment posted by Brenda Seaton on the “Canadian EHR Professionals” LinkedIn group discussion forum, healthcare CIOs “have pushed back because of the very legitimate operational challenges, of which legacy systems are one“. Based on what I am hearing from other sources, these concerns are causing Health Canada to reconsider their definition of patient management software.
So, it appears that the community is divided on the application of the Health Canada regulations, with the vendors lining up in support of the regulations and the health IT user community working behind the scenes to lobby for additional changes to the regulations. There is little public information available regarding these discussions and the views of the various stakeholders. Does anyone have any additional insight that they can share?
While Health Canada is moving ahead with licensing of health IT software as medical devices, the Federal Drug Administration (FDA) in the US is contemplating possible regulation of smartphone applications that monitor vital signs. The FDA appears to moving cautiously. According to an article in eWeek.com, “the FDA plans to seek public input before issuing a final document”. FDA spokesperson Dick Thompson notes that “Some mobile applications are very similar to traditional software applications that the FDA has already classified or regulated, but we believe that further clarifications on mobile applications would be helpful.”
Given the confusion surrounding the Health Canada regulations regarding licensing of health IT software, I wonder if they also apply to smartphone applications?
I am attending a workshop on certification of patient management software hosted by ITAC Health and MEDEC. There has been considerable debate in the Canadian health IT community ever since Health Canada notified the community of it’s intent to consider what it calls patient management software as a medical device and impose relevant licensing regulation. A presentation by Health Canada this morning did little, it seems, to clarify the confusion and perhaps raised even more questions.
Health Canada did share their current working definition for patient management software. This definition did not appear in the May notice from Health Canada and it is the first time that I have seen it. According to Health Canada, patient management software:
- provides the only means and opportunity to capture
or acquire data from a medical device for aiding directly
in diagnosis or treatment
- replaces a diagnostic or treatment measurement or
calculation made by a professional
The second half of this definition is still apparently subject to infernal discussions at Health Canada.
This past weekend there was a spate of tweets, most of them retweets, related to a “new” auditor general’s report. As reported in an earlier blog post, this audit report was released Nov 3/2009. Digging beyond the highlights reported in the mainstream press, the AG’s report concluded:
- “Canada Health Infoway is exercising due regard in managing funds from the federal government to achieve its goal related to the implementation of electronic health records (EHRs) across Canada.”
- “Infoway has set a good foundation for the work it is doing by applying appropriate governance mechanisms to carry out its mandate and objectives.”
- “It has also implemented appropriate management controls for operational spending, although controls for contracting for goods and services need to be strengthened.”
- “Infoway is exercising due regard in approving, monitoring, and making best use of its funds for EHR projects. However, Infoway ought to better document its analyses of project deliverables before releasing payments.”
- “Infoway approves projects that are designed to align with the Blueprint and comply with standards. However, it does not have sufficient assurance that, once implemented, projects will comply with these requirements.”
- “…the Corporation does not annually report progress achieved against expected progress and it does not report on its performance targets that are related to the use of EHR systems. Also, it does not report on project adoption and project compliance with requirements for national compatibility. This information is important to providing a complete picture of progress achieved.”
- “Health Canada ensures that Infoway complies with the funding agreements. However, at the time of the audit, the Department had not yet fully developed an approach to its ongoing monitoring activities to detect early warning of potential non-compliance.”
- “Infoway has accomplished much in the eight years since its creation. Progress achieved thus far required the collaboration of Infoway, all provinces and territories, and other stakeholders. Significant challenges remain to ensuring that tangible benefits of EHRs are realized across the country.”
These conclusions hardly seem to point to widespread problems or misspending of public funds.
I have stated in past blog posts that I support the concept of a national eHealth agency and that, in general, I support Canada Health Infoway That said, there is clearly some public dissatisfaction with Infoway and its operations. I encourage continued debate regarding further Infoway funding and offer this blog as a vehicle for such discussions. I am more interested in an open and vigorous debate than I am defending Infoway.