Licensing of Patient Management Software
Health Canada, Medical Devices Bureau/ ITAC Health
Date: October 15, 2009
Location: 150 Tunney’s Pasture Driveway, Ottawa
In Attendance: Sarah Chandler, Health Canada
Colin Foster-Hunt, Health Canada
Gary Folker, ITAC Health/xwave
Brendan Seaton, ITAC Health
Dr. Jay Mercer, Canadian Medical Association
1. The meeting was arranged at the request of ITAC Health to discuss the implications of the August 31, 2009 notice concerning the licensing of Patient Management Software and workable transition strategies to enable vendors to achieve compliance with licensing requirements.
2. ITAC represents more than 300 Information and Communications Technology (ICT) companies in Canada, of whom approximately 130 provide ICT products and services to the health sector. Not all companies are members of ITAC. It is estimated that there are approximately 450 ICT companies in Canada providing products and services to the health sector.
3. ITAC Health stressed at the outset that the Association did not dispute the licensing requirement in general, but stressed that a workable transition strategy was critical to enable vendors to achieve compliance without disrupting the delivery of health care or government sponsored initiatives in the health ICT marketplace.
4. ITAC Health reviewed the scope and magnitude of the licensing challenge. Some of the points raised:
• Patient management software covers a wide range of applications including primary care, hospital emergency and acute care, community care, public health, ambulance emergency services, homecare, pharmacy, laboratory and diagnostic imaging, and many other health services.
• According to Canada Health Infoway, in 2006 there were more than 40,000 information systems in active use in the Canadian healthcare system.
• Reviewing the Canada Health Infoway iEHR Blueprint, it was noted that the vision for electronic health records (EHR) in Canada involved a complex array of software products operated by health care providers and provincial and federal government jurisdictions. This includes point-of-service applications operated by health care providers, registries and EHR repositories operated by health regions and provincial governments, and many middleware components to facilitate secure communications between the many systems.
• The Federal and Provincial governments are aggressively promoting wide scale deployment of EHR and Electronic Medical Record (EMR) systems over the next 2 to 5 years. Governments are investing billions of dollars to achieve ambitious targets to have EHRs for the majority of Canadians by 2015 (e.g. the Federal Government has announced $500 million for Canada Health Infoway as part of its economic stimulus package. The Ontario Government has announced $2.1 billion over the next 3 years to implement EHR solutions). This will require the deployment of thousands of Patient Management Software systems over this time period.
• While exact figures are not yet available, it is known that a large number of vendors who develop and sell Patient Management Software in the Canadian healthcare marketplace and their products are not yet licensed.
• Based on the current notice, those vendors who are not currently licensed at the Class I level (i.e. the majority) have no clear “line of sight” to regulatory compliance. There is no transition period or strategy that will enable them to obtain ISO certification and product licensing without compromising their ability to develop, sell and support their products in the intervening period.
• ITAC Health believes that the majority of the products developed and sold by its members would fall into the Class II category.
• Several provincial jurisdictions including British Columbia, Alberta, Saskatchewan, Manitoba and Ontario, and Canada Health Infoway have established software certification programs to ensure interoperability with the provincial EHR infrastructures. Vendors, and in particular those who sell EMRs to the physician community, are currently expending significant resources to achieve compliance with the provincial programs. At present, Class I or Class II licenses are not required under these programs. It is expected that the August 31 notice will compel provincial jurisdictions to make licensing a requirement.
5. ITAC Health expressed the concerns of the vendor and health care provider community over the possible disruption to health services and to the ongoing sale and deployment of health information systems as a result of the notice. For example:
• The Canadian Medical Association is seeking the view of the Canadian Medical Protective Association concerning the legal status and liability of physicians who use unlicensed software products in their practices.
• EMR vendors are concerned that medical device licensing requirements will be adopted immediately by provincial funding programs for EMRs, effectively locking most vendors out of the marketplace.
• There is uncertainty over the status of the 40,000+ systems currently deployed in the Canadian healthcare system and whether or not users and user organizations are at risk of legal liability by their continued operation.
6. Health Canada indicated:
• They appreciated the feedback from Industry.
• It is not the intention of Health Canada to disrupt in any way the delivery of health services or programs promoting the use of EHRs or EMRs.
• Health Canada does plan to amend the August 31, 2009 notice and will consider the issues raised by ITAC Health.
However, they also noted that:
• The requirement for licensing is not new. It has been in effect for at least 4 years.
• It is the responsibility of vendors to undertake their own due diligence to determine regulatory requirements.
7. Health Canada and ITAC Health discussed various options for a transition period to enable vendors to become compliant with licensing requirements. This included the following:
• ITAC Health suggested that one approach would be to have all vendors immediately register their products as Class I devices and obtain establishment licenses, and then transitioning to Class II over a defined period of time. Health Canada indicated that this might not be an efficient way to proceed, as it would only add an additional step for those vendors who must obtain Class II licenses.
• ITAC Health indicated that for most vendors, compliance would involve two major stages. The first stage would be to determine what changes each organization must make in order to obtain ISO certification, and then to undertake those changes. The second stage would involve certification by an authorized ISO registration agent. The vendor would be dependent upon the availability, time and resource constraints of the registrar.
• ITAC Health suggested that a realistic time frame for undertaking both stages would be in the range of 36 to 48 months.
• ITAC Health indicated that whatever transition period is established, consideration must be given to the legal status of products already deployed in the health care system, and the sale of new products during the transition period. Any situation that bars the use or sale of products will disrupt patient care and the deployment of provincial EHR/EMR programs. Health Canada indicated that this is a legal question that requires the advice of Health Canada’s legal branch, and that they would seek advice on the matter.
8. ITAC Health indicated that it has consulted with MEDEC and believes that the two associations are in sync concerning the licensing matter. The two associations will continue to collaborate with each other and with Health Canada to ensure that a workable strategy for industry compliance can be found.
9. Health Canada and ITAC Health discussed communications and messaging concerning any announcement of an extended transition period for vendors whose products are not currently licensed as Class I or Class II medical devices. This included the following:
• ITAC Health suggested that the central message be that licensing, combined with a workable transition strategy over a reasonable period of time, was the best way to protect patients and health care providers who rely on Patient Management Software. Disruptions in the use or sale of Patient Management Software will compromise the ability of physicians and other healthcare providers to provide effective health care and delay the policy objectives of the federal and provincial governments to deploy EHR solutions to improve patient outcomes and the effectiveness of the healthcare system.
• ITAC Health has invited Health Canada to participate in a podcast with CanadianEMR to get its message out to the vendor and health care community. Such a podcast will make sense after Health Canada amends the notice.
• ITAC Health and Health Canada will continue to work together to find ways to effectively communicate with vendors and health care providers.
10. Action items from the meeting are as follows:
• ITAC Health will prepare minutes for this meeting for approval by Health Canada.
• Brendan Seaton and Colin Foster-Hunt will meet by telecon to discuss the table of software scenarios previously submitted by ITAC Health to Health Canada for their advice.
• Health Canada will seek legal advice concerning the status of Patient Management Software used or sold during any transition period.