The Issue
The range of medical devices used in modern healthcare delivery is broad and wide ranging. It includes everything from the iconic physicians stethoscope to highly sophisticated magnetic resonance imaging (MRI) machines. With technological advance, an increasing number of medical devices are supported by computerization and software integration.
To provide just a few examples, software is integral to the function of devices such as infusion pumps, ventilators, dialysis machines, imaging systems (CT scanners, ultrasound), x-ray and endoscopy systems, anesthesia machines, and glucose monitoring systems. The trend toward software integration in medical device design has run parallel to other commercial and industrial contexts and has brought benefits that enhance the functionality, safety, and efficacy of healthcare delivery.
But software dependency can also enable downstream challenges in relation to the repair and servicing of devices. No matter how sophisticated a device or system may be, it will need to be repaired and serviced throughout its useful life.
Manufacturers and vendors of devices can rely on software-based controls and contractual terms to restrict or prevent third-party repair and servicing of crucial hospital equipment. These software-based controls can prevent proper calibration of a device following a repair carried out by a technician not authorized by the vendor, or prevent access to device error logs or other technical information needed to diagnose faults.
Parallel to software-based restrictions, manufacturers and vendors may also rely on exclusive intellectual property rights to deny access to replacement parts, specialized tools, and service documentation needed for technicians to effectively repair and service devices. These restrictions may also negatively impact fair competition.
As came to light during the acute phase of the COVID-19 pandemic, the consequences of these restrictions can be catastrophic, resulting in delay to crucial care delivery and placing enormous strain on already limited healthcare budgets across the country.
The Project
Unlocking Healthcare aims to develop new insights into the technical, legal, and contractual barriers to independent repair and servicing of software-dependent medical devices across Canada. This includes an investigation into software-based restrictions that narrow who may repair or service devices, limited access to training programs and certification for independent technicians, as well as contractual terms that prevent anyone other than the vendor or manufacturer’s technicians from repairing or servicing devices.
Our research aims to identify the specific legal and policy barriers to independent repair and servicing of software-dependent medical devices and to propose reforms that promote greater repairability and market competition without compromising patient safety or data security. The project’s goal is to provide critical insights into how Canadian healthcare authorities and hospitals can improve the availability and reliability of essential medical equipment, ultimately supporting a more efficient and resilient healthcare system that is best able to deliver care to the public.