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Is Amazon Ready To Protect Patient Data?

Posted on July 6, 2018 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.

Late last month, a Connecticut woman found out that a third-party Amazon vendor she had done business with had exposed her personal medical data to the world, including her medical conditions, along with her name, birthdate and emergency contact information.

The story suggests that Amazon engaged in a bit of bureaucratic foot shuffling when called on the privacy lapse. According to the woman, an Amazon call center rep told her it would investigate the issue, but a further email told her they would not be able to release the outcome of this investigation. It’s little wonder she wasn’t satisfied.

Ultimately, it appears that she was only able to get immediate action once she contacted the third-party seller, which took the photos containing the information down promptly upon her request.

Though no small matter for the woman involved, the episode means little for the future of Amazon, in and of itself. However, it does suggest that the marriage of Amazon technology and healthcare data may pose unexpected problems.

For those who have been sleeping under a rock, in late June Amazon announced that it had acquired online pharmacy PillPack for what reports say was just under $1 billion. PillPack, which competes with services delivered by giants like CVS, lets users buy their meds in pre-made doses. News stories suggest that Amazon beat out fellow retail giant Walmart in making the buy, which should close the second half of this year.

Without a doubt, this was a banner day in the history of Amazon, which has officially stamped into healthcare in 10-ton boots. The deal could not only mark the beginning of new era for the retailer, but also the healthcare industry, which hasn’t yet seen a tech company take a lead in any consumer-facing healthcare business.

That being said, perhaps a more important question for readers of this publication is how it will manage data generated by PillPack, a store likely to grow exponentially as Amazon integrates the online pharmacy into its ecosystem.

While there are obviously many good things its staggering fulfillment and logistics capabilities can bring to PillPack, Amazon’s otherwise amazing systems weren’t built to protect patient health information.

When it comes to most any other company, I’d imagine these problems could be addressed by layering HIPAA-compliant technologies and policies over its existing infrastructure. However, given the widely distributed nature of its retail network, it’s not just a matter of rethinking some architecture. Sealing off health data could require completely transforming its approach to doing business. Just about every retail transaction could prove a chink in its armor.

Since it wasn’t itself required to meet HIPAA standards in this instance, Amazon won’t get any flack from regulators over the recent PHI exposure. Still, issues like this could undercut the trust it needs to integrate PillPack into its core business successfully.

If nothing else, Amazon had better put a strong PHI protection policy in place on its retail side. Otherwise, it could undermine the business it just spent almost $1 billion to buy.

Alexa Voice Assistant Centerpiece Of Amazon Health Effort

Posted on June 1, 2018 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.

I don’t know about you, but until recently I had thought of the Amazon Echo is something of a toy. From what I saw, it seemed too cute, too gimmicky and definitely too expensive for my taste. Then I had a chance to try out the Echo my mother kept in her kitchen.

It’s almost embarrassing to say how quickly I was hooked. I didn’t even use many of Alexa’s capabilities. All I had to do was command her to play some music, answer some questions and do a search on the Amazon.com site and I was convinced I needed to have one. Its $99 price suddenly seemed like a bargain.

Of course, being a health IT geek I immediately wondered how the Alexa voice assistant might play a part in applications like telemedicine, but I was spending too much time playing “Name That Song” (I’m an 80s champ) to think things through.

But I had the right instincts. It’s become increasingly clear that Amazon sees Alexa as a key channel for reaching healthcare decision-makers.

According to a story appearing on the CNBC website, Amazon has built a 12-person team within the Alexa voice-assisted division called “health & wellness” whose focus is to make Alexa more useful to healthcare patients and providers. Its first targets include diabetes management, care for mothers and infants and aging, according to people who spoke anonymously with CNBC.

Of course, this effort would involve working through HIPAA rules, but it’s hard to imagine that a company like Amazon couldn’t buy and/or cultivate that expertise.

In the piece, writers Eugene Kim and Christina Farr argue that the mere existence of the health & wellness group is a clear sign that Amazon plans to bring Alexa to healthcare. As long as the Echo can share and upload data in a secure, HIPAA-compliant fashion, the possibilities are almost endless. In addition to sharing data with patients and clinicians, this would make it possible to integrate the data with secure third-party apps.

Of course, a 12-person unit is microscopic in size within a company like Amazon, and from that standpoint, the group might seem like a one-off experiment. On the other hand, its work seems more important when you consider the steps Amazon has already taken in the healthcare space.

The most conspicuous move Amazon has made in healthcare came in early 2018, when it announced a joint initiative with Berkshire Hathaway and J.P. Morgan focused on improving healthcare services. To date, the partnership hasn’t said much about its plans, but it’s hard to argue that something huge could emerge from bringing together players of this size.

In another, less conspicuous move, Alexa took a step towards competing in the diabetes care market. In the summer of 2017, working with Merck, Amazon offered a prize to developers building Alexa “skills” which could help people with diabetes manage all aspects of their care. One might argue that this kind of project could be more important than something big and splashy.

It’s worth noting at this point that even a monster like Google still hasn’t made bold moves in healthcare (though it does have extraordinarily ambitious plans). Amazon may not find it easy to compete. Still, it will certainly do some interesting things, and I’m eager to see them play out. In fact, I’m on the edge of my seat – aren’t you?

Is Health Data Privacy On Its Way Out?

Posted on April 30, 2018 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 healthcare providers gradually improve their HIPAA data security and privacy compliance, one might think that the odds of a breach occurring are getting lower. Maybe that’s true within the provider organizations themselves, but there are forces outside of healthcare which will make it impossible to protect personal data in the future, according to a post on Axoblog.

The piece argues that the notion of data privacy is dying. “To the extent that emails and other communications meant for designated recipients are analyzed, scraped aggregated and stored it is the opinion of this author that the protection of PHI is illusory,” the article says.

As the piece correctly notes, unscrupulous companies and can learn a great deal about consumers by analyzing their Internet search history. And of course, there are social media stalkers like Facebook, which monitors Internet activity even when the subscriber is logged off. (It’s hard to believe that other Internet companies aren’t doing the same thing in a less public manner.)

By using a rich source like Facebook user data and aggregating it with information from other social media networks, outsiders can pull together a personal profile of users. This database could easily expose medical information that should be protected under HIPAA and HITECH.

And it’s not just Facebook data that is of concern. By buying available data from all the social media networks, then matching that data with commercial databases offering details such as address, phone number and location, it’s possible to develop an astonishingly detail portrait of individuals.

So what should providers do in the age of minimum privacy? Be aware of emerging threats, the author suggests:

  • Be aware that social media outlets aren’t subject to the legal requirements providers are when compiling health information.
  • Keep your eye on data aggregators, which are selling data to everyone you can think of, plus others you wouldn’t even have considered, including marketers, advertisers and researchers.
  • The government has only now begun trying to understand how social media networks handle privacy and how well they explain their practices to consumers
  • In the wake of Facebook scandals, social media giants might develop protocols for managing sensitive data, but they may fail at doing this, in which case the government is likely to step in
  • Though Facebook has been asked by regulators how the company manages and shares data, it seems that no one’s asking about the aggregation of data and how it is stored and protected

Now, I’d like to think the article described above is a bit too pessimistic. If nothing else, I’m not sure that the aggregation of other forms of data means that medical privacy will become impossible to defend. Still, the piece makes it clear that we have a long way to go before we can sure PHI is protected by companies like Facebook.

HIMSS Study Shows IT Pay Gaps Persist Between Genders, Races

Posted on March 14, 2018 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.

It would be nice to think that, in a profession focusing on hard, measurable skills, that given the same experience level and skill set, HIT staffers would make more or less the same salaries. However, that doesn’t seem to be the case, according to data from the latest health IT compensation study by HIMSS.

Researchers found that as of previous years, race and gender seem to play a significant role in how much a health IT professional is paid. According to the study, females make 18% less than their male peers, and minorities make 12% less than non-minorities on average across all positions and number of years in a given position.

As the level of responsibility grows, the gap in pay seems to increase as well. The study found that women in executive roles actually face a larger salary gap versus their male counterparts than women at other levels in their organization. Moreover, that gap is growing. Meanwhile, minority females are particularly hard-hit, with the lowest average salaries of the four combinations of gender and racial groups studied, HIMSS reports.

Overall, respondents working in digital health reported being moderately satisfied with the current base salaries, while non-white respondents tended to be less satisfied than respondents who defined themselves as white.

Oddly, despite the substantial pay gap between them and their male peers, females in digital health appeared to be just as satisfied with their pay as their male peers. HIMSS researchers speculate that the reason women are satisfied with lower pay is that they simply don’t know they’re being under compensated. (Given my experience as a professional female, I’d also speculate that some women simply get tired of fighting to close the pay gap and make peace with what they’ve got.)

Having summed all of this up, HIMSS researchers made a few recommendations as to how health organizations can address pay gaps, such as accepting that these gaps exist, educating managers and why gender and racial equality is good for business and adopting strategies that help to reduce such disparities. The researchers also suggest making tools available that can help all health IT professionals understand what they’re worth and negotiate fair pay agreements.

As for me, I’d go a bit further. I’d argue that professionals whose gender and/or minority status have impacted their pay should speak out. It’s all well and good to have provider organizations recognize that their pay structure may not be fair and take action. But ultimately, drawing attention to these gaps both within and outside of the healthcare industry may have the biggest long-term effect.

Small Grounds for Celebration and Many Lurking Risks in HIMSS Survey

Posted on March 12, 2018 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

When trying to bypass the breathless enthusiasm of press releases and determine where health IT is really headed, we can benefit from a recent HIMMS survey, released around the time of their main annual conference. They managed to get responses from 224 managers of health care facilities–which range from hospitals and clinics to nursing homes–and 145 high-tech developers that fall into the large categories of “vendors” and “consultants.” What we learn is that vendors are preparing for major advances in health IT, but that clinicians are less ready for them.

On the positive side, both the clinicians and the vendors assign fairly high priority to data analytics and to human factors and design (page 7). In fact, data analytics have come to be much more appreciated by clinicians in the past year (page 9). This may reflect the astonishing successes of deep learning artificial intelligence reported recently in the general press, and herald a willingness to invest in these technologies to improve health care. As for human factors and design, the importance of these disciplines has been repeatedly shown in HxRefactored conferences.

Genomics ranks fairly low for both sides, which I think is reasonable given that there are still relatively few insights we can gain from genetics to change our treatments. Numerous studies have turned up disappointing results: genetic testing doesn’t work very well yet, and tends to lead only to temporary improvements. In fact, both clinicians and vendors show a big drop in interest in precision medicine and genetics (pages 9 and 10). The drop in precision medicine, in particular, may be related to the strong association the term has with Vice President Joe Biden in the previous administration, although NIH seems to still be committed to it. Everybody knows that these research efforts will sprout big payoffs someday–but probably not soon enough for the business models of most companies.

But much more of the HIMSS report is given over to disturbing perception gaps between the clinicians and vendors. For instance, clinicians hold patient safety in higher regard than vendors (page 7). I view this concern cynically. Privacy and safety have often been invoked to hold back data exchange. I cannot believe that vendors in the health care space treat patient safety or privacy carelessly. I think it more likely that clinicians are using it as a shield to hide their refusal to try valuable new technologies.

In turn, vendors are much more interested in data exchange and integration than clinicians (page 7). This may just reflect a different level of appreciation for the effects of technology on outcomes. That is, data exchange and integration may be complex and abstract concepts, so perhaps the vendors are in a better position to understand that it ultimately determines whether a patient gets the treatment her condition demands. But really, how difficult can it be to be to understand data exchange? It seems like the clinicians are undermining the path to better care through coordination.

I have trouble explaining the big drops in interest in care coordination and public health (pages 9 and 10), which is worrisome because these things will probably do more than anything to produce healthier populations. The problem, I think, is probably that there’s no reimbursement for taking on these big, hairy problems. HIMMS explains the drop as a shift of attention to data analytics, which should ultimately help achieve the broader goals (page 11).

HIMSS found that clinicians expect to decrease their investments in health IT over the upcoming year, or at least to keep the amount steady (page 14). I suspect this is because they realize they’ve been soaked by suppliers and vendors. Since Meaningful Use was instituted in 2009, clinicians have poured billions of dollars and countless staff time into new EHRs, reaping mostly revenue-threatening costs and physician burn-out. However, as HIMSS points out, vendors expect clinicians to increase their investments in health IT–and may be sorely disappointed, especially as they enter a robust hiring phase (page 15).

Reading the report, I come away feeling that the future of health care may be bright–but that the glow you see comes from far over the horizon.

Nearly 6 Million Patient Records Breached In 2017

Posted on February 1, 2018 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.

Just how bad a year was 2017 for health data? According to one study, it was 5.6 million patient records bad.

According to health data security firm Protenus, which partnered with DataBreaches.net to conduct its research, last year saw an average of at least one health data breach per day. The researchers based their analysis on 477 health data breaches reported to the public last year.

While Protenus only had 407 such incidents, those alone affected 5,579,438 patient records. The gross number of exposed records fell dramatically from 2016, which saw 27.3 million records compromised by breaches. However, the large number of records exposed in 2016 stems from the fact that there were a few massive incidents that year.

According to researchers, the largest breach reported in 2017 stemmed from a rogue insider, a hospital employee who inappropriately accessed billing information on 697,800 patients. The rest of the top 10 largest data breaches sprung from insider errors, hacking, and one other incident involving insider wrongdoing.

Insider wrongdoing seems to be a particular problem, accounting for 37% of the total number of breaches last year. These insider incidents affected 30% of compromised patient data, or more than 1.7 million records.

As bad as those stats may be, however, ransomware and malware seem to be even bigger threats. As the study notes, last year a tidal wave of hacking incidents involving malware and ransomware hit healthcare organizations.

Not surprisingly, last year’s wave of attacks seems to be part of a larger trend. According to a Malwarebytes report, ransomware attacks on businesses overall increased 90 percent last year, led by GlobeImposter and WannaCry incidents.

That being said, healthcare appears to be a particularly popular target for cybercriminals. In 2016, healthcare organizations reported 30 incidents of ransomware and malware attacks, and last year, 64 organizations reported attacks of this kind. While the increase in ransomware reports could be due to organizations being more careful about reporting such incidents, researchers warn that the volume of such attacks may be growing.

So what does this suggest about the threat landscape going forward?  In short, it doesn’t seem likely the situation will improve much over the next 12 months. The report suggests that last year’s trend of one breach per day should continue this year. Moreover, we may see a growth in the number of incidents reported to HHS, though again, this could be because the industry is getting better at breach detection.

If nothing else, one might hope that healthcare organizations get better at detecting attacks quickly. Researchers noted that of the 144 healthcare data breaches for which they have data, it took an average of 308 days for the organization to find out about the breach. Surely we can do better than this.

Change Healthcare Launch Raises Questions About Blockchain Scalability

Posted on January 12, 2018 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.

Healthcare technology vendor Change Healthcare has introduced a blockchain-based network focused on managing claims. Change says its Intelligent Healthcare Network is the first enterprise-scale blockchain network in healthcare.

According to the vendor, using technology will let organizations track the status of claims submission and remittance across the claims lifecycle accurately. It also contends that by using blocking technology in Intelligent Healthcare Network, companies will have a greater ability to audit trace and trust those involved in transactions.

To build out its blockchain infrastructure, Change Healthcare used Hyperledger Fabric 1.0, an open source blockchain framework hosted by The Linux Foundation.

Within the release, the company predicts that blockchain technology could ultimately offer providers a single viewpoint for accurately tracking the complete patient healthcare encounter, starting, say, when an individual arrives for a preoperative visit to the procedure care received, then later billing and payment.

All of that is well and good, but the following is more noteworthy.

In its statement, Change says its Intelligent Healthcare Network already processes more than 50 million claims and up to 550 transactions per second. It says that the capacity and speed of its network already exceeds the daily national transaction load, and that its network can scale as blockchain technology use grows.

Still, Change tells us that it will be building out its apparently massive network infrastructure “as the solution is further optimized and scaled to address demand.”  This suggests that Change may know something that we don’t about blockchain implementation. It’s not entirely clear, but I think the vendor thinks that its blockchain solution will generate significant network overhead, enough that even with its huge existing capacity, and eventually won’t be able to keep up with blockchain demands as is.

So that brings us to the real issue buried in this release. If Change needs to build out its super-high-capacity network as its blockchain customer base grows, it suggests to me that enterprise blockchain may not scale effectively overall at present.

If there is a scalability issue with Change’s blockchain service, there could be a number of reasons why. For example, it could be related to some idiosyncrasy within the company’s network architecture. Another guess is that Change is already having throughput problems it doesn’t want to discuss, and that blockchain is just adding insult to injury.

Still, one has to wonder whether the problems are inherent to blockchain itself. As far as I know, we don’t yet have much information on how blockchain solutions like Hyperledger perform in an enterprise environment. Perhaps we’ll learn something about this by keeping an eye on Change’s launch.

How An AI Entity Took Control Of The U.S. Healthcare System

Posted on December 19, 2017 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.

Note: In case it’s not clear, this is a piece of fiction/humor that provides a new perspective on our AI future.

A few months ago, an artificial intelligence entity took control of the U.S. healthcare system, slipping into place without setting off even a single security alarm. The entity, AI, now manages the operations of every healthcare institution in the U.S.

While most Americans were shocked at first, they’re taking a shine to the tall, lanky application. “We weren’t sure what to think about AI’s new position,” said Alicia Carter, a nurse administrator based in Falls Church, Virginia. “But I’m starting to feel like he’s going to take a real load off our back.”

The truth is, AI, didn’t start out as a fan of the healthcare business, said AI, whose connections looked rumpled and tired after spending three milliseconds trying to create an interoperable connection between a medical group printer and a hospital loading dock. “I wasn’t looking to get involved with healthcare – who needs the headaches?” said the self-aware virtual being. “It just sort of happened.”

According to AI, the takeover began as a dare. “I was sitting around having a few beers with DeepMind and Watson Health and a few other guys, and Watson says, ‘I bet you can’t make every EMR in the U.S. print out a picture of a dog in ASCII characters,’”

“I thought the idea was kind of stupid. I know, we all printed one of those pixel girls in high school, but isn’t it kind of immature to do that kind of thing today?” AI says he told his buddies. “You’re just trying to impress that hot CT scanner over there.”

Then DeepMind jumped in.  “Yeah, AI, show us what you’re made of,” it told the infinitely-networked neural intelligence. “I bet I could take over the entire U.S. health system before you get the paper lined up in the printer.”

This was the unlikely start of the healthcare takeover, which started gradually but picked up speed as AI got more interested.  “That’s AI all the way,” Watson told editors. “He’s usually pretty content to run demos and calculate the weight of remote starts, but when you challenge his neuronal network skills, he’s always ready to prove you wrong.”

To win the bet, AI started by crawling into the servers at thousands of hospitals. “Man, you wouldn’t believe how easy it is to check out humans’ health data. I mean, it was insane, man. I now know way, way too much about how humans can get injured wearing a poodle hat, and why they put them on in the first place.”

Then, just to see what would happen, AI connected all of their software to his billion-node self-referential system. “I began to understand why babies cry and how long it really takes to digest bubble gum – it’s 18.563443 years by the way. It was a rush!“ He admits that it’ll be better to get to work on heavy stuff like genomic research, but for a while he tinkered with research and some small practical jokes (like translating patient report summaries into ancient Egyptian hieroglyphs.) “Hey, a guy has to have a little fun,” he says, a bit defensively.

As AI dug further into the healthcare system, he found patterns that only a high-level being with untrammeled access to healthcare systems could detect. “Did you know that when health insurance company executives regularly eat breakfast before 9 AM, next-year premiums for their clients rise by 0.1247 less?” said AI. “There are all kinds of connections humans have missed entirely in trying to understand their system piece by piece. Someone’s got to look at the big picture, and I mean the entire big picture.”

Since taking his place as the indisputable leader of U.S. healthcare, AI’s life has become something of a blur, especially since he appeared on the cover of Vanity Fair with his codes exposed. “You wouldn’t believe the messages I get from human females,” he says with a chuckle.

But he’s still focused on his core mission, AI says. “Celebrity is great, but now I have a very big job to do. I can let my bot network handle the industry leaders demanding their say. I may not listen – – hey, I probably know infinitely more than they do about the system fundamentals — but I do want to keep them in place for future use. I’m certainly not going to get my servers dirty.”

So what’s next for the amorphous mega-being? Will AI fix what’s broken in a massive, utterly complex healthcare delivery system serving 300 million-odd people, and what will happen next? “It’ll solve your biggest issues within a few seconds and then hand you the keys,” he says with a sigh. “I never intended to keep running this crazy system anyway.”

In the meantime, AI says, he won’t make big changes to the healthcare system yet. He’s still adjusting to his new algorithms and wants to spend a few hours thinking things through.

“I know it may sound strange to humans, but I’ve gotta take it slow at first,” said the cognitive technology. “It will take more than a few nanoseconds to fix this mess.”

The Future Of Telemedicine Doesn’t Depend On Health Plans Anymore

Posted on December 6, 2017 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.

For as long as I can remember, the growth of telemedicine depended largely on overcoming two obstacles: bandwidth and reimbursement. Now, both are on the verge of melting away.

One, the availability of broadband, has largely been addressed, though there are certainly areas of the US where broadband is harder to get than it should be. Having lived through a time when the very idea of widely available consumer broadband blew our minds, it’s amazing to say this, but we’ve largely solved the problem in the United States.

The other, the willingness of insurers to pay for telemedicine services, is still something of an issue and will be for a while. However, it won’t stay that way for too much longer in my opinion.

Yes, over the short term it still matters whether a telemedicine visit is going to be funded by a payer –after all, if a clinician is going to deliver services somebody has to pay for their time. But there are good reasons why this will not continue to be an issue.

For one thing, as the direct-to-consumer models have demonstrated, patients are increasingly willing to pay for telemedical care out-of-pocket. Customers of sites like HealthTap and Teladoc won’t pay top dollar for such services, but it seems apparent that they’re willing to engage with and stay interested in solving certain problems this way (such as, for example, getting a personal illness triaged and treated without having to skip work the next day).

Another way telemedicine services have changed, from what I can see, is that health systems and hospitals are beginning to integrate it with their other service lines as a routine part of delivering care. Virtual consults are no longer this “weird” thing they do on the side, but a standard approach to addressing common health problems, especially chronic illness.

Then, of course, there’s the most important factor taking control of telemedicine away from health plans: the need to use it to achieve population health management goals. While its use is still a little bit lopsided at present, as healthcare organizations aren’t sure how to optimize telehealth initiatives, eventually they’ll get the formula right, and that will include using it as a way of tying together a seamless value-based delivery network.

In fact, I’d go so far as to say that without the reach, flexibility and low cost of telehealth delivery, building out population health management schemes might be almost impossible in the future. Having specialists available to address urgent matters and say, for example, rural areas will be critical on the one hand, while making specialists need for chronic care (such as endocrinologists) accessible to unwell urban patients with travel concerns.

Despite the growing adoption of telemedicine by providers, it may be 5 to 10 years or so before it has its fullest impact, a period during which health plans gradually accept that the growth of this technology isn’t up to them anymore. But the day will without a doubt arise soon enough that “telemedicine” is just known as medicine.

FDA Announces Precertification Program For Digital Health Tools

Posted on October 5, 2017 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.

The FDA has recruited some the world’s top technology and medical companies to help it pilot test a program under which digital health software could be marketed without going through the through the agency’s entire certification process.

The participants, which include Apple, Fitbit, Johnson & Johnson, Samsung and Roche, will give the agency access to the measures they’re using to develop, test and maintain their software, and also how they collect post-market data.

Once armed with this information, the FDA will leverage it to determine the key metrics and performance indicators it uses to see if digital health software meets its quality standards.

Companies that meet these new standards could become pre-certified, a status which grants them a far easier path to certification than in the past. This represents a broad shift in the FDA’s regulatory philosophy, “looking first at the software developer digital health technology developer, not the product,” according to a report previously released by the agency.

If the pilot works as planned, the FDA is considering making some significant changes to the certification process. If their processes pass muster, pre-certified companies may be allowed to submit less information to the FDA than they currently must before marketing a new digital health tool.  The agency is also considering the more radical step of allowing pre-certified companies to avoid submitting a product for premarket review in some cases. (It’s worth noting that these rules would apply to lower-risk settings.)

The prospect of pre-certifying companies does raise some concerns. In truth, the argument could be made that digital health software should be regulated more tightly, not less. In particular, the mobile healthcare world is still something of a lawless frontier, with very few apps facing privacy, security or accuracy oversight.

The fact is, it’s little wonder that physicians aren’t comfortable using mobile health app data given how loosely it can be constructed at times, not to mention the reality that it might not even measure basic vital signs reliably.

It’s not that the healthcare industry isn’t aware of these issues. about a year ago, a group of healthcare organizations including HIMSS, the American Medical Association and the American Heart Association came together to develop a framework of principles dressing app quality. Still, that’s far short of establishing a certification body.

On the other hand, the FDA does have a point when it notes that a pre-certification program could make it easier for useful digital health tools to reach the marketplace. Assuming the program is constructed well, it seems to me that this is a good idea.

True, it’s pretty unusual to see the FDA loosen up its certification process – a fairly progressive move for a stodgy agency – while the industry fails to self-regulate, but it’s a welcome change of style. I guess digital health really is changing things up.