Monday, August 16, 2010

Are application service providers (ASP) subject to the Medical Devices Regulations?

Note: Exact text provided by Health Canada

ASPs (application service providers) do not fall within the scope of the Regulations since no sale of a medical device is taking place. However, if the ASP has purchased a medical device with which the ASP is providing a service, the manufacturer of the device is still required to comply with the requirements of the Medical Devices Regulations and obtain the appropriate licence prior to the sale to the ASP.

How will Health Canada treat legacy systems?

Note: Exact text provided by Health Canada.

For the purposes of this document, “legacy system” is defined as follows:

“legacy system” is software that was designed, sold and deployed prior to February 1, 2011 (Class I) or September 1, 2011 (Class II).

The Medical Devices Regulations prohibit the sale of a Class II, III or IV medical device unless the manufacturer of the device holds a device licence in respect of it. However, as legacy systems have been previously sold without immediate risks to public health having been identified, they have not been prioritized for compliance with this prohibition until September 1, 2011. After that date the sale of a legacy system that is a Class II, III or IV device without a licence will be prioritized for compliance as any other device (according to Policy 001 of the Health Product and Food Branch Inspectorate).

An establishment that imports or sells any medical device must also hold an Establishment Licence (“EL”) to do so. Compliance with that requirement has similarly not been prioritized until February 1, 2011. After that date the import or sale of a legacy system device without an EL will be prioritized for compliance as any other similar device (according to Policy 001 of the Health Product and Food Branch Inspectorate).

Neither servicing, maintenance nor use of a device is governed by these Regulations. Upgrading to a new version of the software, if the functionality, intended uses, or nomenclature of the system is altered, would be a “sale” of a medical device, and the new version would need to be licensed.

Is patient management software developed in-house by health care organizations subject to the Medical Devices Regulations?

Medical devices developed and used exclusively in-house by healthcare providers do not fall within the scope of the Regulations as they do not meet Section 2 of the regulations:

2. These Regulations apply to
(a) the sale and advertising for sale of a medical device; and
(b) the importation of a medical device for sale or for use on individuals, other than importation for personal use.

[Note: This answer was reviewed by Health Canada]

Is Middleware a Medical Device?

Note: Exact text provided by Health Canada.

For the purposes of this document, “middleware” is defined as follows:

“middleware” means a piece of software that connects two or more software applications so that they can exchange data. This includes software systems that facilitate the interaction of disparate components through a set of commonly defined protocols. The purpose is to limit the number of interfaces required for interoperability by allowing all components to interact with the Middleware using a common interface.

As defined above middleware would not fit the definition of a medical device.

Are COTS products Medical Devices?

COTS products (Commercial Off The Shelf) that are developed for general commercial use and are not specific to health care such as database applications, encryption applications, and web portal applications, are not considered medical devices, even when they are integrated into health information systems and infrastructures that process personal health information.

However, where COTS products such as databases and portals are integrated into a patient management software product that is classed as a Class II device, the patient management software manufacturer must verify and validate that the COTS product has been safely and effectively configured and integrated into the patient management software product.

[Note: This answer was reviewed by Health Canada]

Wednesday, August 11, 2010

Are EMRs Medical Devices?


ITAC Health and MEDEC met with Health Canada by teleconference on Tuesday, August 10, 2010, to discuss issues surrounding Patient Management Software. One of the issues that required clarification was the question of whether or not Electronic Medical Records (EMRs) were Medical Devices under the Medical Devices Regulations. Health Canada clarified its interpretation as follows:

EMRs that are only intended to store and view patient information, and provide no analysis or decision support respecting diagnosis or treatment, do not fit the definition of a medical device (for example: the system captures and displays age, weight, notes about a patient’s appointment, patient test results, order processing, scheduling, or managing patient movement).

This would include software that would scan all of the patient records in a database, and based on some pre-determined criteria (age, gender, chronic diseases (diabetes, hypertension, heart disease), date of last test or immunization and combinations thereof), would flag to the physician, other heath care provider or admin staff to contact the patient and schedule the appropriate followup visit or test.

Such EMRs are not medical devices and do not require a medical device license unless they also perform one or more of the functions below and are used for diagnostic and/or treatment purposes.

EMRs are classed as Class II devices if they are used for the purpose of monitoring a physiological condition, state of health, illness or congenital deformity. This includes any patient management software involved in data manipulation, data analysis, data editing, image generation, determination of measurements, graphing, flagging of results, identifying a region of interest or performing calculations. Only software performing calculations that directly impact diagnosis and/or treatment of a patient merits a Class II designation.

For example:

1. An EMR that analyzes and provides the necessary information to flag drug interactions and patient allergies for a specific patient is a Class II device.

2. An EMR that receives and analyzes lab data for a specific patient and flags values that are out of the normal range is a Class II device.

There are few, if any, situations where an EMR will be classed as a Class I device. Health Canada is reviewing its definition of Class I devices to include only those devices that use real time data as an adjunct to a monitoring device for the purpose of aiding in treatment and/or diagnosis.

ITAC Health strongly recommends that if a manufacturer, vendor or distributor of an EMR has any doubt as to the appropriate classification of their product, that they contact Health Canada for a ruling. Be sure to maintain documentation of any advice provided by Health Canada on the classification of EMR products.

Patient Management Software Conference

ITAC Health and MEDEC invite you to an educational conference on Health Canada's recently released Patient Management Software Notice on Wednesday, September 8, 2010 in Toronto.

The conference is open to ITAC Health, MEDEC and COACH members and non-members.

Topics Include:

"Overview of Patient Management Software Notice and the Requirements for Licensing"
Sarah Chandler, Health Canada

"Customer Point of View" presentation and panel discussion
Neil Gardner, CIO, Saskatchewan Health
Lydia Lee, CIO, University Health Network Toronto
William Pascal, CTO, Canadian Medical Association

Vendor panel -- "The Good, the Bad and the Ugly of Navigating the Licensing Process"
Joe Whitney, MedManager
Laila Gurney, GE Healthcare

"Registrar's Outline on How to Prepare for ISO 13485:2003 CMDCAS"
Dion Goncalves, Intertek

Opportunity to network with others working through the process

Allstream Centre
Exhibition Place
105 Princes' Blvd.
Room 200 A/B/C, Toronto, ON M6K 3C3

For more information check out the ITAC Website.