As a COACH Board Director and an active digital health leader in my day job, taking on the additional role for COACH of leading eSafety in Canada as a volunteer was not an easy decision. Hundreds of hours were dedicated to conceptualizing, strategizing, writing guidelines, crafting presentations and cajoling others to hop on the train, but I can truly say it was worth every ounce of effort. Leading eSafety in Canada has been one of the highlights of my career.
The launch of eSafety in Canada
Five years ago, the digital health industry understood health software and the systems we were implementing to advance digital health and vastly improve patient care also presented risks that we needed to mitigate so that no harm was done to patients. Many studies had been published, such as the Institute of Medicine’s “To Err Is Human: Building A Safer Health System,” and awareness
was beginning to rise that more preventive safeguards were needed. But no formal programs or approaches existed in Canada to guide the digital health community (jurisdictions, implementers, clinicians and vendors) on how to approach eSafety. While patient safety was a mainstay focus for hospitals in Canada, and embedded formally into regulation on certain medical devices, there were no regulations or guidelines in the vast new world of “ehealth.” Furthermore, gaps in international standards existed and did not cover important areas of eSafety risk such as culture, reporting and usability.
Consequently, we set out on our journey in Canada to identify experts from various domains (academic, vendor, clinical, quality, etc.) and formed a national working group to develop strong guidelines, trial them on “real” digital health projects across Canada, and publish the eSafety Guidelines. We presented at COACH and HIMSS conferences, met with international experts around the world (NHS UK, Australia, and academics from the US) and read all the published literature we could find. We also approached many national and jurisdictional organizations (Canada Health Infoway, Information Technology Association of Canada, Canadian Institute for Health Information, College of Physicians and Surgeons of Ontario, Canadian Medical Association, Canadian Nursing Informatics Association, etc.) and garnered their support. We spent a lot of time emphasizing the “burning platform for change” and why eSafety was important and grew the movement across Canada. Jurisdictions and other stakeholders began adopting or trialing the Guidelines nationally – starting with Infoway, Alberta, Northwest Territories, Newfoundland, Ontario, and vendors like Healthtech, GE, Orion Health and Gevity. In 2015, we held our first national COACH eSafety Summit in Edmonton Alberta, thanks to Alberta Health Services’ support and international experts like Drs. Dean Sittig and Farah Magrabi who collaborated with Canadian participants to lead important eSafety discussions and advance our thinking.
Today, several national and jurisdictional working groups continue to promote eSafety – and I will describe some of their advances below. But before we go there – I think it is important to highlight some of the most recent findings on eSafety risks to ground this work.
Why is eSafety important to Canada? Where does the risk lie?
International experts have helpfully started to classify and categorize areas of risk in digital health.
In a recent Finnish published dissertation, the author first thanks her Canadian professors, Drs. Elizabeth Borycki and Andre Kushniruk1 at the University of Victoria for their leadership in technology-induced errors, and then identifies the following results from literature searches that were extracted and grouped by these specific technology-induced error types:
- Incorrect patient identification
- Extended EHR unavailability
- Failure to heed a computer-generated warning or alert
- System-to-system interface errors
- Failure to identify, find, or use the most recent patient data
- Misunderstandings about time
- Incorrect item selection from a list of items
- Open or incomplete orders
In addition, Singh, Ash and Sittig (2013) developed self-assessment guides to optimize the safe use of EHRs. The Safety Assurance Factors for EHR Resilience (SAFER) guides were also designed to help clinicians and health care organizations self-assess the safety and effectiveness of their EHR implementations, recognize areas of vulnerability and develop practices to mitigate risks.
How is eSafety being applied in Canada?
One of the most rewarding milestones on this eSafety journey was watching the COACH eSafety learnings being tested and applied across Canada. Since 2013, others have joined these initial trendsetters and begun to formally incorporate eSafety practices into their organizations. Here are a few examples:
- OntarioMD trialed the eSafety Guidelines in 2013 and created a case for safety on their Health Report Manager application prior to go-live. OntarioMD is presently leading an eSafety Case for the Provincial eConsult service (partnering with the Ontario Telemedicine Network and eHealth Ontario) and co-chairs the Ontario eSafety Working Group focused on promoting eSafety adoption.
- Alberta Health Services have formally adopted the eSafety Guidelines and have incorporated a formal eSafety role into their organization.
- SickKids Hospital is using the SAFER guides and the COACH eSafety principles on their upcoming HIS implementation.
- eHealth Ontario purchased the license for the eSafety Guidelines for Ontario use, co-chairs the Ontario eSafety Working Group and is launching their own eSafety program.
- Orion Health has been exploring categories of risk as they apply to their own products. Also, Orion has committed senior leaders who are volunteering their experience and energy to drive the COACH eSafety Community of Action.
How is Canada contributing globally to new standards in eSafety?
Parallel global ISO standards work aligned to the eSafety Guidelines was started in the fall of 2011 and resulted in a Canadian-led, accepted Technical Report standard being published in 2013. This standard, ISO/TR 17791:2013(E) Health informatics — Guidance
on standards for enabling safety in health software, provided guidance to countries, readers and our eSafety by identifying a coherent set of international standards relevant to the development, implementation and use of safer health software.
Using a systems lifecycle and granularity framework, the Technical Report identifies eight risk, process and domain-specific standards that provide a starting point and are applicable in addressing risks associated with health software safety.
Additional work is underway in the international standards community (ISO and others):
- An Incident and eSafety Adverse Event Reporting Standard, Canadian-led, provides categorization and structuring of reporting adverse events,
- A Health Software and Health IT Safety Standards – Future State Architecture/Framework and Roadmap was developed in 2015 and Canadian co-led.
- eSafety is being incorporated into health software safety plans for all software and medical devices in the US
What does the future look like for eSafety in Canada?
We have come a long way in the last five years in recognizing the importance of eSafety and developing approaches to managing risks. There is increasing buy-in from both public and private organizations to adopt eSafety practices and address vulnerabilities. Moving forward, we will need more formalized incident reporting, which will require recognizing standard categories of risk. We will also need to start addressing the growing dynamic nature of digital health, which is highly unregulated (apps, mobile, etc.), and begin harnessing data analytics to start helping us address eSafety. Most importantly, we will keep learning, through more real-life experience and implementations by Canadians and extraordinary volunteers, to lead practice on the national and global stage.
In conclusion, as we continue to expand EHR systems implementation, we need to be aware of the risks to patient safety. Moreover, because of the intricacy of health care processes (multiple hubs, applications and responsible organizations, etc.) the potential for health information technology to cause errors is a concern. eSafety programs and practices will help identify areas of vulnerability and increase the ability to mitigate risks.
In closing, this article is a tribute to the many who worked with me to advance eSafety in Canada as volunteers. I cannot name all of you (dozens of Working Group members and guideline authors and daily safety champions and warriors), but thank you for jumping on the eSafety train, your contribution makes a huge difference to our digital health community. For new and interested volunteers, join the COACH eSafety Community of Action to keep advancing eSafety in Canada!