By coordinating regulations governing digital health technologies, Canada and the US can improve healthcare services in both countries.
In partnership with HIMSS and Personal Connected Health Alliance (PCHAlliance), we hosted the Canada-US Connected Health Workshop in December 2016. Today, with HIMSS and PCHAlliance, we released a follow-up report to the workshop that highlights opportunities for improved cross-border partnership in digital health. As Canada, the U.S. and Mexico assemble for their third round of NAFTA negotiations, we raise important considerations for digital trade in health information technology.
Canada and the US share a long history of economic cooperation, healthcare is one important sector often overlooked. Although the two countries’ health systems are perceived to have little in common, many similarities exist in the way they operate.
In particular, the rapid growth of digitally driven “connected health” is creating exciting new opportunities for delivering better care — and a need for further regulatory and policy coordination.
Widespread use of connected health technologies also comes with risks. The impact of the recent “WannaCry” file-encrypting malware outbreak on the UK’s National Health Service underscores the need for cooperation in cybersecurity.
To achieve its full potential, connected health requires innovative privacy and security solutions to overcome barriers to adoption and the skepticism of patients about how their personal information is used. Through the Canada–US Regulatory Cooperation Council (RCC), the two countries can address these concerns and realize the promise of connected health.
Meanwhile, negotiations to modernize the North American Free Trade Agreement (NAFTA) provide an opportunity for expanding Canada, U.S. and Mexico trade in digital health technologies while enhancing privacy and security.
Common interests and challenges
Advances in healthcare today depend on leveraging data to produce value-based results from secure datasets. Coordination and information sharing between Canada and the US are essential to accelerate the growth and adoption of connected health technologies.
Such cooperation can be complicated, not only by political and regulatory barriers, but also by factors, such as language, geography, and cultural differences. Collaboration needs to be cultivated on several fronts.
The following areas require particular attention.
Regulatory systems must keep pace with digital health.
Regulatory agencies need to build capacity to adjust to the rapid pace of technological advancements. A practical initial step toward harmonization would be to agree on definitions and vocabulary in connected health and establish a common set of principles for the clinical evaluation of software.
Multi-agency cooperation may be necessary within each country as well as between them, due to overlapping regulatory authorities.
Administrative barriers hinder telehealth.
Public policy needs to catch up with the widespread use of telehealth technologies, which enable care to delivered at a distance. Rather than enhancing these valuable services, some laws and regulations prevent virtual care from being available in certain areas, as does uncertainty around billing and reimbursement.
Canada and the US should review common barriers and strategies to improve access to telehealth for rural and vulnerable communities.
The healthcare supply chain could improve patient safety and system efficiency.
The healthcare supply chain has untapped potential for connecting Canada and the US, which share highly integrated supply chains in other sectors. The adoption of identification standards in the health sector would be a move in this direction. Regulatory consistency on privacy would promote innovation. Considering the tremendous complexity and unevenness between jurisdictions in privacy matters, any moves toward greater simplicity and consistency could help accelerate innovation and improve security.
Easing cross-border barriers to collecting and storing health data for purposes like patient treatment, commercial transactions, processing, or long-term storage could produce efficiency gains and accessibility in both countries.
An agreement on health data would need to establish a uniform set of controls that strike a balance between security, privacy, and accessibility.
Interoperability remains a challenge.
Interoperability of digital systems is essential to making health data useful. Healthcare organizations need their systems to communicate with each other to use patient data to empower physicians and patients. With great strides made toward this goal, it remains a goal to achieve.
Health information and analytics can help achieve major health goals.
Outbreaks of H1N1, Ebola, and Zika as well as the opioid crisis demonstrate the importance of cross-border collaboration in public health. Sharing information on patient populations is also vital for dealing with long-term health issues such as the rise of chronic diseases.
Data analytics holds great promise for improving care but also brings a demand for appropriate regulations and standards across different sectors.
The way forward
Considering these various challenges and opportunities, three key recommendations arose from the Canada–US Connected Health Workshop and subsequent consultations.
Address barriers to regulatory harmonization through RCC and NAFTA renegotiation.
This would help ensure that Canada and the US work collaboratively to harness the potential of new technology and create economic opportunities while addressing safety and security concerns.
Through RCC, the two countries have established a track record in regulatory harmonization in areas, such as new drug applications and software as a medical device. There is potential to utilize RCC to tackle similar harmonization in digital health.
Furthermore, as NAFTA parties consider negotiating a chapter on digital trade, they should contemplate provisions to allow for expanded trade in digital health technologies in a way that meets demands for privacy and security. NAFTA negotiations provide an opportunity to align Mexico’s regulatory framework for digital trade in health with Canada and the United States. In 2013, Mexico launched a National Digital Strategy, which listed “universal and effective public health” as one of its five priorities. Mexico has also established the office of National Digital Strategy Coordinator, a senior leadership position held by Alejandra Lagunes, who brings experience from Google, Yahoo and Microsoft in Mexico.
Establish a Canada–US Health Privacy and Security Forum.
This Forum would promote knowledge exchange and regulatory consistency, help create a common front for protecting health privacy, and foster economic and trade opportunities for technology providers.
Bringing together privacy regulators, enforcement officers, and health stakeholders, the Forum would share information about common risks, develop common goals, and identify areas where coordination might be beneficial to security and economic interests.
A dialogue on health privacy protection would be a natural extension to the Canada-US “Beyond the Border” Action Plan’s Joint Statement on Privacy Principles.
Pursue a Memorandum of Understanding to govern the use of health records for research.
This would help realize the great potential for the two countries to combine datasets while establishing a common understanding about the use of digital health records for research.
Data mining and analytics have the potential to improve health quality and lead to advances in population health by identifying key trends.