Meeting - ITAC Health and Health Canada - October 15, 2009

Minutes
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.

Classification of Software Scenerios

ITAC Health recently submitted a number of software scenarios to Health Canada to get a sense of what constitutes a Class I or Class II medical device.

The following list is a guide only and does not represent any definitive rulings by Health Canada. Companies in doubt as to whether their software is a Class I or Class II device can contact Health Canada's Medical Devices Bureau for a ruling. To initiate an action for a ruling, send an email containing a basic description of your company and the software in question (very brief) together with contact information for someone in your company who can discuss the application with Health Canada. The email can be sent to: DEVICE_LICENSING@hc-sc.gc.ca. Health Canada will contact you to discuss the process and any additional information required. More information can be found on the Health Canada website.

For scenarios where it is indicated that the class is (to be determined), this is the class Health Canada is leaning towards, but does not have enough information to provide firm advice at this time. Companies selling such software should contact Health Canada at the email address above.

1. Physician Software System - Scheduling and billing only, no manipulation or alteration of clinical data: Not a medical device

2. Physician Software System - Records and displays demographic and clinical data only with no manipulation or alteration of data: Class I

3. Physician Software System - Electronic Medical Record - contains decision support functions, manipulates and displays data in different formats: Class II

4. Physician Software System - Accesses and uses information and decision support functions provided by provincial or regional electronic health record systems: Class II

5. Electronic Health Record System - Custom developed by a health care organization or government health ministry (e.g. chronic disease registry, public health surveillance) for exclusive use by that health care organization or government health ministry: Not a medical device for sale or distribution

6. Electronic Health Record System - Custom developed by a health care organization or government health ministry (e.g. chronic disease registry, public health surveillance) and is given to, or sold to another health care organization or government health ministry: Class II

7. Electronic Health Record System - Custom developed by a health care organization or government health ministry (e.g. chronic disease registry, public health surveillance) where a private sector developer retains ownership of the end-product which is subsequently sold to another health care organization or government health ministry: Class II

8. Commercial Off-the-Shelf (COTS) Software - that is not healthcare specific but is used for clinical applications or is integrated into a health information system (e.g. office automation software, email software, operating systems, database software, web portal software, etc.): Not a medical device

9. Custom developed middleware that is developed to facilitate communications between health information systems and is distributed to multiple health care organization or jurisdictions (e.g. translation of proprietary clinical codes or messages into standard formats such as HL7 or SNOWMED CT) - Class I (to be determined)

10. COTS middleware that is not healthcare specific but is used to facilitate communications between health information systems: Not a medical device

11. Security system software that is not healthcare specific but is used to control access to and use of health information systems (e.g. encryption software, authentication systems): Not a medical device

12. Hospital administrative and financial systems (e.g. materials management, general ledger, billing): Not a medical device

13. Hospital ADT (admissions, discharge and transfer) systems: Not a medical device

14. Hospital clinical management systems (e.g. pharmacy, lab, diagnostic imaging, computerized physician order entry): Class II (to be determined)

15. Consumer health platforms - software systems available to consumers and healthcare providers on the internet that allow consumers and healthcare providers to enter, view, graph and manipulate personal health information (e.g. Microsoft HealthVault, Google Health): Class II (to be determined)

ITAC Health Working Group

ITAC Health has established a Working Group to address vendor interests concerning the Patient Management Software licensing issue. At its first teleconference on Wednesday, October 7, 2009 it was decided that the first order of business for the Working Group will be on promoting a workable transition strategy to Health Canada, and to provide information to Health Canada to help them better understand the impacts of the licensing program on the health care system and health ICT marketplace.

Gary Folker, Managing Director, Healthcare for xWave, and a director on the ITAC Health Board, will chair the Working Group.

People interested in participating in the Working Group should contact ITAC Health Executive Director Elaine Huesing at ehuesing@itac.ca.

CanadianEMR to Develop Podcasts on Software Licensing

CanadianEMR and ITAC Health are in discussions to create a series of podcasts to provide basic information to the vendor and health care communities. Three proposed podcasts are being discussed:

1. A vendor-oriented podcast with an EMR vendor who has gone through the process and the chair of the ITAC Health working group discussing what the licensing means in practical terms for vendors.

2. A podcast with Health Canada to clarify the policy notice and any related issues.

3. A podcast with several jurisdictional programs including PITO, POSP, OntarioMD and perhaps Infoway to discuss what the licensing issue means to the provincial and national programs.

Podcasts 2 and 3 will require discussions with Health Canada and the provincial programs. Watch this blog for progress on these and other communications initiatives.

Class II Application - What's Required?

Section 32(2) of the Medical Devices Regulations outlines the requirements for a Class II License application.

An application for a Class II medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:

(a) a description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented;

(b) a list of the standards complied with in the manufacture of the device to satisfy the safety and effectiveness requirements;

(c) an attestation by a senior official of the manufacturer that the manufacturer has objective evidence to establish that the device meets the safety and effectiveness requirements;

(d) an attestation by a senior official of the manufacturer that the device label meets the applicable labelling requirements of these Regulations;

(e) in the case of a near patient in vitro diagnostic device, an attestation by a senior official of the manufacturer that investigational testing has been conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use; and

(f) a copy of the quality management system certificate certifying that the quality management system under which the device is manufactured satisfies National Standard of Canada CAN/CSA-ISO 13485:03, Medical devices — Quality management systems — Requirements for regulatory purposes.

Broad Definition of "Sell"

Compulsory licensing applies to patient management software sold in Canada. The definition of "sell" in the Food and Drugs Act is very broad. The Act states "sell" includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration.

According to an official of Health Canada contacted on this date, this means that any distribution of any patient management software, even if there is no financial transaction, constitutes a sale. This would include patient management software developed for one provincial Ministry of Health and provided to a Ministry of Health in another province (with or without financial charge).

No Grace Period for Unlicensed Software

The Health Canada notice dated August 31, 2009 states, "If manufacturers previously received a Class I ruling from Health Canada, but their software now falls into Class II (as defined above), a one-year transition period will be granted to the manufacturers in order to be able to meet all the regulatory requirements outlined under section 32(2) of the Medical Devices Regulations. This transition period is effective as of the date of this notice" (August 31, 2009).

According to an official of Health Canada contacted on this date, this transition applies only to software that has previously ruled as Class I. Software that has not been classified as Class I by Health Canada is subject to licensing immediately. There is no transition or grace period. Nor are there any grandfathering provisions for patient management software currently in use.

Compulsory Licensing for Patient Management Software

Health Canada has recently issued a notice that patient management software is now considered a medical device and is subject to compulsory licensing. This notice will impact any developer and/or vendor of health care software in Canada. Patient management software can be categorized as a Class I or Class II device.

Any patient management software used only for archiving or viewing information or images, and not involved in the primary acquisition, manipulation and transfer of data, is considered a Class I medical device. Although Class I devices do not require a license, manufacturers, distributors and importers are required to obtain an establishment license.

Patient management software involved in data manipulation, data analysis, data editing, image generation, recording of measurements, graphing, flagging of results or performing calculations is considered a Class II medical device, as is any primary workstation that interfaces directly with a system (imaging or other type) by acquiring data and then sending data to an image generating, viewing or storage device. Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a medical device license.

Click here for a copy of the notice. More information is available on the Health Canada website at the following URL: http://www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php.

ITAC Health is establishing a working group to help members address this new requirement. If you are interested in participating in the working group, please contact me at bseaton@itac.ca.

The ITAC Health Blog

Welcome to the ITAC Health Blog. This blog has been setup to facilitate discussion and the dissemination of information to ITAC Members on issues of concern to the health information and communications technology (HICT) industry. More information about ITAC can be found on our website at www.itac.ca.