At Last: Evidence-Based Med Tech Reviews

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NODE health is the Network for Digital Evidence – a group of clinicians, researchers and developers who set themselves the task of evaluating digital health. Brought together by Dr. Ashish Atreja, NODE holds that digital health devices and platforms are lacking the studies and evidence that we associate with other healthcare interventions. It’s the goal of NODE to generate and apply this evidence. NODE members represent a diverse group of academic innovation centers, industry, investors, and entrepreneurs. Telemedicine editor Nicholas Genes sat down with Ashish to talk about his work – where NODE came from, and where he thinks it’s going. 

Interview by Nicholas Genes, MD, PhD

Telemedicine Magazine: Why have so many well-meaning clinicians and developers released apps without good evidence? We’d never do that for a drug, after all. And why have prior approaches at evaluating health apps failed?

Ashish Atreja: There’s a general perception that an app can’t hurt you. But think of Google Maps, which can steer users into a ditch. Any app can carry unintended consequences. Bates just published a great paper in JAMA on this topic, how digital health must strike a balance between innovative problem-solving and patient safety. Of course, there are apps that will require FDA approval – but we need a system to evaluate the quality, usability and value of the other 99% of apps that will not go through the FDA process. But NODE Health is about more than evaluating apps – it’s about creating an ecosystem for partnerships, to develop a science for mHealth and digital medicine. We’re seeing too much fragmentation – 165,000 apps out there in the Apple and Google stores, and too many health innovation centers that aren’t sharing what they’re doing. There’s too much needless duplication. We wouldn’t be good doctors if we didn’t go to conferences and learn from each other – but that’s not happening enough in mHealth. Instead when we do have conferences they are vendor-based, and it’s not always clear what to trust. So as NODE network we’re making a platform, a system, to develop trustworthy processes so that folks can find high-quality apps and feel safe using them. NODE Health will be a crowdsourced community. It will include payers, doctors, and patients as well. Accelerators, VCs can contribute. No one will be excluded – but it will be transparent and unbiased.

TM: You’ve won grants to build mHealth apps, to engage with patients over the web and through apps. Why did you start down this path?

Atreja: Really the first thing that got me into mHealth was UpToDate, from my first day on the job at the Cleveland Clinic. My first patient in clinic was a lung transplant patient, and I had never seen a lung transplant patient before. It was 2000 and the world wide web was just getting underway. My senior resident told me to check out UpToDate – it was fast, and there was pertinent information for this specific case, stuff that wasn’t in Harrison’s – even a video. It was a new way to see the evidence, it was curated, and there was obviously a sophisticated back end. In short, technology was making a difference in healthcare. That got me interested in how I can leverage technology in healthcare further. I don’t consider myself a geek – I’m not a coder or engineer – but I am a believer in the potential for technology.

TM: Where is the need for app evaluation greatest? Is it the apps for providers, or the patient-focused health and therapy apps? Will NODE evaluate both kinds of apps?

Atreja: NODE will help both patients and providers navigate and choose high-quality apps. Right now we’re more focused on patient-centered apps but there’s also resources for telemedicine, and provider-focused tools. We will end up with working groups to evaluate tools for population health, messaging between doctors and patients, and more. The current health and wellness apps and devices from Apple and Android are really just business-to-consumer. The only comments we see are from end-users. But that has to change. We need trusted intermediaries to evaluate before we can prescribe or recommend these apps to patients.

TM: NODE seems unapologetically academic, so can it scale? How can it keep up, in a world where apps are constantly introducing new features, new versions?

Atreja: NODE can keep up, because of crowdsourcing. Every app, every company, will have a profile page. The profile has got to be maintained, and the vendors themselves will want to issue updates. But they may want to put spin on their content – so we need someone unbiased to review their claims and approve it before it’s visible to the community. We have to leverage the power of the community. NODE Health has three guiding principles. First: sharing data about ongoing pilots. Second, standardization – for regulatory policies and governance. Third, multi-site pilots – taking away the biases that come from research done at a single site. This is necessary, as right now a lot of places are evaluating the same app, the same device, in a silo – we need to share data and reduce the number of duplicated pilot projects.

TM: So industry will be involved, but unbiased reviewers from the community will have the final say. What about the government? US regulatory agencies have done a good job protecting consumers from untested drugs. But these same agencies haven’t tried to regulate EHR. Is NODE a necessary role that the government is neglecting?

Atreja: We’re not aiming to have a regulatory effect or try to police the field. And we’ve certainly spoken to regulators and government officials. We’re focused on knowledge and data sharing. We can help doctors and patients adopt digital medicine tools. We’ll providing checklists and a pathway that startups will want to follow, to increase their apps’ adoption and get the services underway at more institutions. Right now it takes nine months to onboard a technology at a hospital. If a new startup wants to follow Node precepts, I hope we can say: they’ll launch faster. We’ll be encouraging adoption of standards, and when an app or company has shortcomings, we’ll be clear about it, but really we’re offering a carrot; NODE is not a stick. Regarding industry, there’s some news to share. HIMSS/PCHA (the Personal Connected Health Alliance) is going to be a co-founding partner for NODE Health. NODE Health remains independent, but HIMSS liked the approach and they wanted to have a neutral, unbiased voice. HIMSS will have a seat on the NODE Health steering committee. But at its heart, individuals will still be the most important aspect of the community. And individuals can serve as nodes, themselves – to distribute apps, reviews or insights to, say, the telemedicine community or the emergency medicine community. ACC (American College of Cardiology) is coming onboard, the GI society is on board. Many specialties will be represented, and each issue of the newsletter will highlight different specialties, the different parts of the ecosystem.

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