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Scanadu to Shut Down Scout Medical Device Per FDA Regulation

Posted on December 14, 2016 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

The famous Qualcomm Tricorder prize winner and IndieGogo crowdfunding success, Scanadu, has just hit some major bumps in the road. In fact, you might say they lost their engine completely. After winning the X Prize foundation’s tricorder competition, they went on to raise more than $1.6 million on IndieGogo from 8509 backers.

After shipping the product, Techcrunch just broke the news that Scanadu was now planning to disable the Scout’s functionality. Yes, that’s right. People paid $149-269 for the Scanadu Scout and now Scanadu is going to brick all of the devices. Here’s their official comment to Techcrunch:

“From the beginning of the campaign, this was an investigational device that was part of a study which has now reached its endpoint with data collection for the study ending in November 2016. FDA regulations require that all investigational studies be brought to closure and their respective devices be deactivated. As a result, we will deactivate the Scanadu Scout® devices by May 15, 2017.

Interestingly, the Scanadu website, Twitter, Facebook, etc are all quiet. In fact, most of them have been quiet since April. What hasn’t been quiet is customers anger towards Scanadu. That’s true on social media, but also in the IndieGogo comment section where Scanadu had raised $1.6 million.

You can imagine people’s anger. Their expensive device will now be useless. As one commenter pointed out, someone bought 100 of them. That person will now essentially have 100 expensive bricks. In the comments, people are calling for a class action lawsuit, refunds from IndieGogo and outrage at the company doing this to them. The most salient point is that it’s hard to imagine anyone ever buying a product from Scanadu again after something like this occurs. One commenter suggested the following:

The consent doc also says: “If you have any questions about your rights, call the Scripps Office for the Protection of Research Subjects at (858) 652-5500. ” [Note: Scripps is performing the study based on the Scanadu data.]

Some people in the comments are even commenting that there’s no such FDA regulation. I’m not an expert on FDA regulation, but my gut tells me there’s more to this story than we know today. I could easily see how there could be an FDA regulation that required a company to shut down devices that made claims they couldn’t achieve and therefore put people’s health in danger. I’m not sure if this is what’s happening with Scanadu, but when there’s smoke there’s usually fire.

I think we all loved the romanticized idea of a medical tricorder. Haven’t we all wanted one since we first saw it portrayed on Star Trek? Scanadu was trying to make it a reality, but it seems their efforts have fallen flat. This is a good warning to everyone else out there. FDA compliance is no joke. Even winning an X Prize, a successful crowd funding campaign, and raising $35 million in funding doesn’t guarantee success.

Innovation in healthcare is hard!

Can Interoperability Drive Value-Based Care?

Posted on I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

As the drive to interoperability has evolved over the last few decades — and those of you who are HIT veterans know that these concerns go at least that far back — open data sharing has gone from being a “nice to have” to a presumed necessity for providing appropriate care.

And along the way, backers of interoperability efforts have expanded their goals. While the need to support coordinated care has always been a basis for the discussion, today the assumption is that value-based care simply isn’t possible without data interoperability between providers.

I don’t disagree with the premise. However, I believe that many providers, health systems and ACOs have significant work to do before they can truly benefit from interoperability. In fact, we may be putting the cart before the horse in this case.

A fragmented system

At present, our health system is straining to meet the demand for care coordination among the populations it serves. That may be in part because the level of chronic illness in the US is particularly high. According to one Health Affairs study, two out of three Americans will have a chronic condition by the year 2030. Add that to the need to care for patients with episodic care needs and the problem becomes staggering.

While some health organizations, particularly integrated systems like the Cleveland Clinic and staff-model managed care plans like Kaiser Permanente, plan for and execute well on care coordination, most others have too many siloes in place to do the job correctly. Though many health systems have installed enterprise EMRs like Epic and Cerner, and share data effectively while the patient remains down in their system, they may do very little to integrate information from community providers, pharmacies, laboratories or diagnostic imaging centers.

I have no doubt that when needed, individual providers collect records from these community organizations. But collecting records on the fly is no substitute for following patients in a comprehensive way.

New models required

Given this history, I’d argue that many health systems simply aren’t ready to take full advantage of freely shared health data today, much less under value-based care payment models of the future.

Before they can use interoperable data effectively, provider organizations will need to integrate outside data into their workflow. They’ll need to put procedures in place on how care coordination works in their environment. This will include not only deciding who integrates of outside data and how, but also how organizations will respond as a whole.

For example, hospitals and clinics will need to figure out who handles care coordination tasks, how many resources to pour into this effort, how this care coordination effort fits into the larger population health strategy and how to measure whether they are succeeding or failing in their care coordination efforts. None of these are trivial tasks, and the questions they raise won’t be answered overnight.

In other words, even if we achieved full interoperability across our health system tomorrow, providers wouldn’t necessarily be able to leverage it right away. In other words, unfettered health data sharing won’t necessarily help providers win at value-based care, at least not right away. In fact, I’d argue that it’s dangerous to act as though interoperability can magically make this happen. Even if full interoperability is necessary, it’s not sufficient. (And of course, even getting there seems like a quixotic goal to some, including myself.)

Planning ahead

That being said, health organizations probably do have time to get their act together on this front. The move to value-based care is happening quickly, but not at light speed, so they do have time to make plans to leverage interoperable health data.

But unless they acknowledge the weaknesses of their current system, which in many cases is myopic, siloed and rigid, interoperability may do little to advance their long-term goals. They’ll have to admit that their current systems are far too inward-looking, and that the problem will only go away if they take responsibility for fixing it.

Otherwise, even full interoperability may do little to advance value-based care. After all, all the data in the world won’t change anything on its own.