Meaningful Consent in Healthcare Innovation: Barrier or Enabler?

Technological innovations have the potential to radically transform our healthcare system – but they often rely on sensitive personal data being collected, used, and shared. How can patients meaningfully consent to reap the benefits?

From artificial intelligence to mobile devices to remote monitoring, tech-based innovations are revolutionizing the healthcare sector – and privacy protections are not keeping pace. It seems we can have healthcare innovation or privacy protection – but not both. However, according to Angela Power, Director of Privacy and Public Engagement for the Newfoundland and Labrador Centre for Health Information (NLCHI), we can have both healthcare innovation and privacy – as long as we are prepared to radically rethink privacy and consent models.

Privacy as an enabler

A keen desire to view privacy as an enabler rather than a barrier to innovation is what led Power, along with Holly Etchegary, to develop a unique Design Jam on  “modernizing consent for the use of personal health information.” With support from the Office of the Privacy Commissioner of Canada, the team aimed to take a deeper look at how meaningful consent could be approached in the health innovation sector.

“Sometimes privacy is deemed to be a barrier to innovation,” says Power. “But we wanted to flip that whole paradigm on its head and say, ‘Well, no, it's not. Why not rethink privacy and consent as an enabler of innovation? Let's open the dialogue. Let's rethink and reimagine consent as supportive of new innovations and technologies, because it shouldn't always be a threat.’”

The team’s first step was to assemble a working group, which brought together stakeholders from across the province and Canada to plan the Design Jam – namely Memorial University; the provincial Department of Health and Community Services; the Newfoundland and Labrador Centre for Health Information; Eastern Health; the Health Research Ethics Authority; Bounce Innovation and Hacking Health; Canada Health Infoway; and, most importantly, a number of patient groups and citizen representatives.

“Let's open the dialogue. Let's rethink and reimagine consent as supportive of new innovations and technologies, because it shouldn't always be a threat.”

The one-day event focused on “putting patients at the heart of health innovation pursuits,” and over the course of the day, more than 50 participants – including patients and citizen representatives, stakeholders from startups and tech companies, as well as regulators – actively engaged in brainstorming and developing solutions. The goal was to explore where consent can be embedded in the health system to maximize patients’ control over the use of their health data.

And the amount of health data being generated nowadays is skyrocketing. Connected devices are increasingly being integrated in hospital and medical care settings, and thousands of Canadians wear remote patient monitoring devices or have had them implanted. So-called “medical wearables” have now become commonplace – from off-the-shelf health trackers to more sophisticated devices like blood glucose monitors that can remotely adjust insulin delivery or heart monitors that can detect irregular patterns and send real-time data to physicians.

Then the pandemic hit, sending an already rapidly accelerating field into hyper-drive.

“With COVID-19, we've seen what was already happening in the health space accelerate almost exponentially overnight,” notes Power. “Virtual care just exploded. Many of us want to reap the benefits of remote monitoring. Many of us want to access these new solutions. But not at a cost to our privacy.”

Tantalizing benefits, but…

Healthcare innovations offer a trio of tantalizing potential benefits: Boosting the quality and safety of patient care, enhancing the patient experience, and ultimately improving medical outcomes. Faced with the twin challenges of an aging population and escalating costs, innovation also promises to improve the economics of healthcare.

But they also rely on sensitive personal data being collected, used, and shared. Are patients able to “meaningfully” consent to the use of their personal data so they can benefit from these devices?

“I’ve seen a lot of examples of healthcare innovations where, yes, the benefits exist, but the transparency is not there,” continues Power. “And I feel deeply concerned when I recognize that even within the health space, data is being mined in extremely troubling ways.”

Along with the use of data in the health space, another troubling issue for Power is the unprecedented number of private and public sector partnerships pursuing healthcare innovations – and how the “tension” between these two sectors is creating unique privacy challenges.

Junction of private and public sectors

“In the last 15 years or so, I’ve seen the entire privacy landscape evolve exponentially alongside many emerging technologies,” notes Power. “In the health space in particular, I’ve seen the private and public sectors merging over and over again. As new technologies emerge, whether it's in artificial intelligence or mobile devices or remote patient monitoring, it's often delivered into a care context via a partnership or some sort of contractual arrangement.”

“At the very least, we wanted the Design Jam to shed light on how data is used, and shine a spotlight on the emerging intersection between the private and public sectors in Canada –especially when the public sector is responsible for the provision of care, but the private sector is embedding these new solutions in emerging technologies,” explains Power.

According to Power, tensions arise because privately run companies and startups must move fast to get a return on their investments, and also prove to the health care system that their technology can provide value and benefit. And these companies need a public health system that can quickly respond to requests for data so they can test and deploy their innovations.

“Jamming” the consent model

Both the healthcare system and regulatory environment are struggling to keep up with the rapid pace of innovation, notes Power, and the usual models for consent and privacy are lagging behind current technological capabilities.

“Patients and the public are similarly challenged in choices about the use of their health information,” Dr. Holly Etchegary explains. “We thought it was time to rethink how to manage privacy and consent to consider new models for real-time, dynamic consent.”

A novel part of the Jam was the composition of “consent working tables”. Each table included a mix of stakeholders, including patients, clinicians, privacy regulators, provincial government decision makers, commercial innovators, and researchers. This ensured a mix of perspectives was applied to the consent focus of each table.

“We wanted to create an opportunity where various stakeholders could openly discuss this issue and explore where the intersection is and what some solutions might look like if we were to create a model for consent moving forward that is both meaningful and aligns with privacy principles. Our goal was: Let's start the dialogue, let's bring together various stakeholders, let's try to break down the divide,” explains Power.

Ironically, one of the biggest initial challenges for the research team was defining the concept of “meaningful consent” within a health context.

“It took us a lot longer at the outset of the Design Jam to help people realize we were talking about consent on the collection, use, and sharing of personal information or data – versus ‘consent for care’,” says Etchegary.

By the end of the process, Design Jam participants proposed a range of potential consent solutions across six different consent gateways: Opportunities at hospital kiosks, provincial health card renewal sites, patient portals, health research portals, at the point of clinical care, and through mobile apps.

Jam organizers offered specific consent considerations for each of the gateways, but common features were evident across all, including the need for multiple consent opportunities, consent models that give patients ultimate control over the use of their personal health data, and models that give patients a chance to revisit – and revise – their consent preferences over time. Developing “dynamic” and “transparent” consent models can help ensure these features are met.

In the end, “consent should not be a dichotomy of either/or thinking: You either have privacy or you have innovation,” notes Power. “The Design Jam demonstrated that it is possible to bring people together to try and solve a complex issue around privacy – the emergence of health tech – so we can reap the benefits and also have privacy.”