Wearables, voice assistants face HIPAA hurdles but remain promising in clinical trials

This morning MassBio hosted a panel on the use cases for the technology in clinical trials and beyond.
By Laura Lovett
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 (Left to right) Nathan Treloar, Sarah Lindenauer and Matteo Lai at the MassBio panel in Cambridge, MA. 

Virtual assistants and wearable technologies are starting to catch the pharma world’s attention. The industry is exploring how the new tools can be used in research, clinical trials and inpatient settings. However, obstacles including privacy compliance and data standards are still questions that the industry is grappling with, according to panelists at the MassBio forum on Using Clinical Data from the Wild: HIPAA Compliant Wearables & Virtual Assistants, this morning. 

“You see a lot of things out there that are not even necessarily HIPAA compliant,” Luba Greenwood, who focuses on strategic business development and corporate ventures at Alphabet subsidiary Verily, said during the panel.  “There are many wearables and other gadgets that claim to be wearables for clinical trials, but there is a big difference between something that you truly use for clinical trials, to get clinical validation and real-world evidence and other wearables that are there for consumer use.”

Data collection is just one component of how wearables and virtual assistants could be implemented in studies. Participant engagement is also key to study success, Nathan Treloar, CEO of Orbita, said during the panel. 

“Once they are enrolled, how do we keep [participants] engaged, so that the data being collected is collected in a timely fashion, and is as accurate and secure as possible? Through the lens of what we do with virtual assistants, there is a lot of interest in voice technologies in reducing the barrier in engagement,” Treloar said. 

When a patient drops out of a study there are also financial consequenes: it can cost the study sponsor around $30,000, Treloar said. Virtual assistance could help support patients that might not be as savvy at navigating digital tools. 

“Traditional visual health technologies that are out there to ensure that patients are doing their daily assessment surveys are on mobile phone app or a website,” he said. “But not every patient is able or willing to use these kinds of digital technologies.”

Both wearable data and voice assistants show promise in passively collecting data that patients previously had to report in a manual mode. This could help with both accuracy and ease in studies. 

Matteo Lai, cofounder and CEO of Empatica, gave the example of a patient with epilepsy, his company's area of focus. This patient may be asked to record when they had a seizure and for how long. But a patient may not be aware of this exact data. That’s where technology might be useful, he said. 

 “Patients now don’t have to report as much,” Lai said. “The data is collected passively and there are not as many actions that they have to do.”

That’s not to say that these technologies are a cure-all. Humans input will still be part of the research equation. 

“I think the ideal is some combination of automated methods of collecting data and where you need to access more subjective information that comes from the patients about how they are feeling, and then reducing the barrier to a more natural interface like voice that can maybe combine with the device itself,” Treloar said. 

Privacy challenges 

Unlike the consumer space, in clinical trials or in an inpatient setting tools need to be HIPAA-compliant. That can be difficult for many startups on a small budget. 

However, more big tech companies like Amazon and Apple are beginning to enter the health arena and offer potential HIPAA-compliant avenues for software companies to operate in. In particular, Amazon Web Service (AWS) has added to its collection of HIPAA-eligible services, which now includes machine learning tools Amazon Translate, Amazon Comprehend and Amazon Transcribe. 

“You asked the question 'How do we compete?'” Treloar said. “We don’t compete with Amazon. We partner with Amazon. Our whole business is predicated on the adoption of smart speakers and virtual speaker platforms.”

But even the big names have hurdles to overcome in terms of compliance. 

“I think as far as smart speakers and virtual assistants [go], Amazon right now only has HIPAA-eligible environments, so basically turning on and off HIPAA for specific skills, enabling HIPAA for a particular voice app or voice skill,” Sarah Lindenauer, product and portfolio manager of the innovation and digital health accelerator (IDHA) at Boston Children’s Hospital, said.  

“Right now it’s invite-only and only select developers or partners would develop skills that process PHI in a HIPAA compliant manner. That is great and a step in the right directions. But when you think about placing a smart speaker in a hospital room there is a whole host of considerations. …The entire platform isn’t HIPAA complaint and you can’t tell, if its patient facing, how the patient is going to use it and the type of information they are going to share, and whether they are going to stay in that one skill that is deemed HIPAA-compliant.”

The value of voice

Even if a technology works in the field and is HIPAA-compliant, investors will want to know a company’s exit strategy, said Greenwood. 

“If there is value probably someone is willing to pay for that service or product,” Lai said. 

But there are many avenues that companies could take including IPOs and acquisitions. With so many digital health companies in the field right now, panelist said consolidation in the field was inevitable.  

It’s no secret that M&As are a big part of the digital health conversation. The first quarter of 2019 alone saw 17 mergers and acquisitions.

Still, in some provider organizations, such as IDHA at Boston Children’s, an exit strategy isn’t the top priority. Some of the accelerator’s startups spin out, but other products are used in-house to solve a problem or help save the organization money. 

Essentially, panelists agreed,when creating digital tools stakeholders have two main considerations. 

“Ultimately digital health is all about two things: Improving outcomes and doing that at a lower cost,” said Greenwood.