Thursday, September 8, 2016
Wednesday, August 17, 2016
Healthcare’s struggle with social media continues, but help may be forthcoming
By NEIL VERSEL
Perhaps the most shocking moment from the 2016 HIMSS conference in Las Vegas that highlights the long road to embracing patient opinion on social media occurred during the opening plenary session.
Mark Barner, CIO of Ascension Health, commented that he doesn’t particularly care about patients going on Twitter to complain about problems with nonclinical issues such as hospital food and parking.
If that raised eyebrows, what Island Coast Pediatrics, a practice in Fort Myers, Florida,reportedly did was jarring. It apparently dropped at least eight families from its patient rolls last month over negative comments parents posted in a closed Facebook group.
Indeed, these are extreme examples and perhaps instances of not-so-enlightened healthcare players when it comes to valuing patient ratings and crowdsourced reviews. Yet, for even those providers that would like to be aware of what is being said and respond, there hasn’t been enough critical mass of social media opinions or a centralized repository that hospitals can mine to get a pulse of public opinion.
“The evidence is that the mass of people are not using rating sites,” according to health economist, consultant and patient engagement specialist Jane Sarasohn-Kahn. “We do not have yet the be-all, end-all, whole enchilada to make it easy.”
Sarasohn-Kahn was talking about consumers rating physicians and hospitals, but it’s the same for institutions trying to figure out how they are doing. There just isn’t a definitive source of information that aggregates and filters patient sentiment.
Hoping to fill the void, Boston Children’s Hospital’s HealthMap, a public health surveillance initiative, created CrowdClinical, which launched in February 2015. CrowdClinical goes to Twitter, Reddit and other “patient-centric” social media sites, including online patient community Inspire, according to John Brownstein, chief innovation officer at Boston Children’s.
“If patients are already talking about you, why not go to them? Why not seek out what people are saying?” Brownstein said. “There’s opportunities to understand the patient voice.”
CrowdClinical employs machine learning and natural-language processing to categorize what people are saying. Brownstein wants to package custom reports about public opinion for hospitals, but is waiting on the HealthMap team to finalize its algorithms.
“We’re focused on making the data as useful as possible,” he said.
Hospitals can use CrowdClinical as a tool to improve quality, Brownstein said. Insights and trends identified from aggregating patient posts can serve as an “early sentinel” of potential problems, he pointed out.
Brownstein was one of the authors of a 2015 paper in the BMJ that studied how Twitter can help measure how patients perceive quality of care. The researchers found that hospitals mentioned more positively in tweets had lower 30-day readmission rates, among other things.
What the study and subsequent observation by Brownstein has also found, perhaps surprisingly, is that it’s not all sour grapes on social media and rating sites.
“It’s actually pretty balanced in terms of praise and complaints,” Brownstein said.
However, on consumer rating sites like Yelp, it’s not as balanced. In fact, healthcare comments there are overwhelmingly positive, according to Emily Washcovick, manager of local business outreach for the San Francisco-based company.
An analysis of online reviews of physicians from 2014 from Software Advice, a Texas company, found that less than 20 percent of posts about physicians were negative. This mirrors a University of Michigan study published in the Journal of the American Medical Association.
“Most [users] are actually generating content about positive experiences,” Washcovick said, echoing Brownstein.
Healthcare is the third-most reviewed type of service on Yelp, after restaurants and retail stores, she reported. People go into detail in all three segments, since users can’t just leave a star rating. They actually have to write something.
Here’s an interesting tidbit about the consumer review site: Yelp’s roots actually are in healthcare. When the company started in 2004, CEO and Co-founder Jeremy Stoppelman was relatively new to the Bay Area. When he got sick, he didn’t have a physician and didn’t know where to turn to evaluate his options.
“That’s where he got the idea for reviews,” according to Washcovick.
Yelp reviews of healthcare providers consider more factors than even Medicare’s Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey,she contended. So it’s important for healthcare providers to pay attention to such consumer-facing sites.
Last year, Yelp teamed with investigative journalism shop ProPublica to add quality and outcomes data to the ratings pages of 25,000 hospitals, nursing homes and dialysis clinics, hopefully improving that experience.
Social media and rating websites certainly can be helpful for patients and providers alike, but healthcare consumerism still is in what Sarasohn-Kahn called a “1.0” phase.
Word of mouth remains the most popular method for finding healthcare providers, though a Nuance Communications study from a year ago found that 54 percent of young millennials — ages 18-24 — check physician ratings before seeing a doctor. That compares to 39 percent among the general population.
More might look online if they could be certain about the accuracy and specificity of what they were reading.
“You’ve got this patchwork quilt of choices, but where does the consumer go?” Sarasohn-Kahn said. “Unless it’s a specific condition, it’s very fragmented.”
And then there is Healthgrades, which Sarasohn-Kahn finds to be “mature and accurate.” But that company’s reports are pricey, and thus only really suitable for people facing life-threatening conditions.
Zagat Survey, known for its easy-to-use restaurant reviews, teamed with health insurer WellPoint — now called Anthem — in 2008 to allow patients to rate their doctors. But that never really took off, and eventually fizzled.
“It’s just really hard to point people to one place,” Sarasohn-Kahn lamented.
But things are moving in the direction of transparency and consumer-friendliness, albeit slowly. And increasingly, patient experience and satisfaction are becoming important considerations in value-based care. As the Nuance survey hinted and the CrowdClinical effort exemplifies, consumers want their voices to be heard and providers — Ascension CIO Barner’s comments notwithstanding — want to know what people are thinking about them.
Geisinger Health System in Pennsylvania last year began offering a money-back guarantee for some services, the equivalent to a warranty for car repairs.
“That’s where this is going to go,” Sarasohn-Kahn said. “Providers need to stand behind their care.”
She noted that Nemours Children’s Health System, based in Wilmington, Delaware, gets good Press Ganey scores for patient satisfaction “because they focus on the 360-degree patient experience.”
For his part, Brownstein was moved by Barner’s comments, which prompted CrowdClinical to begin following social media comments about Ascension.
“We added Ascension to the list [of organizations we track] after that,” Brownstein said. “You have to be listening to your customers.”
Perhaps the most shocking moment from the 2016 HIMSS conference in Las Vegas that highlights the long road to embracing patient opinion on social media occurred during the opening plenary session.
Mark Barner, CIO of Ascension Health, commented that he doesn’t particularly care about patients going on Twitter to complain about problems with nonclinical issues such as hospital food and parking.
If that raised eyebrows, what Island Coast Pediatrics, a practice in Fort Myers, Florida,reportedly did was jarring. It apparently dropped at least eight families from its patient rolls last month over negative comments parents posted in a closed Facebook group.
Indeed, these are extreme examples and perhaps instances of not-so-enlightened healthcare players when it comes to valuing patient ratings and crowdsourced reviews. Yet, for even those providers that would like to be aware of what is being said and respond, there hasn’t been enough critical mass of social media opinions or a centralized repository that hospitals can mine to get a pulse of public opinion.
“The evidence is that the mass of people are not using rating sites,” according to health economist, consultant and patient engagement specialist Jane Sarasohn-Kahn. “We do not have yet the be-all, end-all, whole enchilada to make it easy.”
Sarasohn-Kahn was talking about consumers rating physicians and hospitals, but it’s the same for institutions trying to figure out how they are doing. There just isn’t a definitive source of information that aggregates and filters patient sentiment.
Hoping to fill the void, Boston Children’s Hospital’s HealthMap, a public health surveillance initiative, created CrowdClinical, which launched in February 2015. CrowdClinical goes to Twitter, Reddit and other “patient-centric” social media sites, including online patient community Inspire, according to John Brownstein, chief innovation officer at Boston Children’s.
“If patients are already talking about you, why not go to them? Why not seek out what people are saying?” Brownstein said. “There’s opportunities to understand the patient voice.”
CrowdClinical employs machine learning and natural-language processing to categorize what people are saying. Brownstein wants to package custom reports about public opinion for hospitals, but is waiting on the HealthMap team to finalize its algorithms.
“We’re focused on making the data as useful as possible,” he said.
Hospitals can use CrowdClinical as a tool to improve quality, Brownstein said. Insights and trends identified from aggregating patient posts can serve as an “early sentinel” of potential problems, he pointed out.
Brownstein was one of the authors of a 2015 paper in the BMJ that studied how Twitter can help measure how patients perceive quality of care. The researchers found that hospitals mentioned more positively in tweets had lower 30-day readmission rates, among other things.
What the study and subsequent observation by Brownstein has also found, perhaps surprisingly, is that it’s not all sour grapes on social media and rating sites.
“It’s actually pretty balanced in terms of praise and complaints,” Brownstein said.
However, on consumer rating sites like Yelp, it’s not as balanced. In fact, healthcare comments there are overwhelmingly positive, according to Emily Washcovick, manager of local business outreach for the San Francisco-based company.
An analysis of online reviews of physicians from 2014 from Software Advice, a Texas company, found that less than 20 percent of posts about physicians were negative. This mirrors a University of Michigan study published in the Journal of the American Medical Association.
“Most [users] are actually generating content about positive experiences,” Washcovick said, echoing Brownstein.
Healthcare is the third-most reviewed type of service on Yelp, after restaurants and retail stores, she reported. People go into detail in all three segments, since users can’t just leave a star rating. They actually have to write something.
Here’s an interesting tidbit about the consumer review site: Yelp’s roots actually are in healthcare. When the company started in 2004, CEO and Co-founder Jeremy Stoppelman was relatively new to the Bay Area. When he got sick, he didn’t have a physician and didn’t know where to turn to evaluate his options.
“That’s where he got the idea for reviews,” according to Washcovick.
Yelp reviews of healthcare providers consider more factors than even Medicare’s Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey,she contended. So it’s important for healthcare providers to pay attention to such consumer-facing sites.
Last year, Yelp teamed with investigative journalism shop ProPublica to add quality and outcomes data to the ratings pages of 25,000 hospitals, nursing homes and dialysis clinics, hopefully improving that experience.
Social media and rating websites certainly can be helpful for patients and providers alike, but healthcare consumerism still is in what Sarasohn-Kahn called a “1.0” phase.
Word of mouth remains the most popular method for finding healthcare providers, though a Nuance Communications study from a year ago found that 54 percent of young millennials — ages 18-24 — check physician ratings before seeing a doctor. That compares to 39 percent among the general population.
More might look online if they could be certain about the accuracy and specificity of what they were reading.
“You’ve got this patchwork quilt of choices, but where does the consumer go?” Sarasohn-Kahn said. “Unless it’s a specific condition, it’s very fragmented.”
And then there is Healthgrades, which Sarasohn-Kahn finds to be “mature and accurate.” But that company’s reports are pricey, and thus only really suitable for people facing life-threatening conditions.
Zagat Survey, known for its easy-to-use restaurant reviews, teamed with health insurer WellPoint — now called Anthem — in 2008 to allow patients to rate their doctors. But that never really took off, and eventually fizzled.
“It’s just really hard to point people to one place,” Sarasohn-Kahn lamented.
But things are moving in the direction of transparency and consumer-friendliness, albeit slowly. And increasingly, patient experience and satisfaction are becoming important considerations in value-based care. As the Nuance survey hinted and the CrowdClinical effort exemplifies, consumers want their voices to be heard and providers — Ascension CIO Barner’s comments notwithstanding — want to know what people are thinking about them.
Geisinger Health System in Pennsylvania last year began offering a money-back guarantee for some services, the equivalent to a warranty for car repairs.
“That’s where this is going to go,” Sarasohn-Kahn said. “Providers need to stand behind their care.”
She noted that Nemours Children’s Health System, based in Wilmington, Delaware, gets good Press Ganey scores for patient satisfaction “because they focus on the 360-degree patient experience.”
For his part, Brownstein was moved by Barner’s comments, which prompted CrowdClinical to begin following social media comments about Ascension.
“We added Ascension to the list [of organizations we track] after that,” Brownstein said. “You have to be listening to your customers.”
Tuesday, August 9, 2016
Rumor: Apple working on entirely new, advanced health-tracking hardware for 2017 launch
By Neil Hughes
Tuesday, August 09, 2016
Ten years after the launch of the first iPhone, Apple could be planning to unveil a "killer new product" developed within its health laboratories, a new report claims — though details are vague.
The rumor stems from Taiwan's Economic Daily News, which claims that the new product will "accurately collect users' personal daily life including heart rate, pulse, blood sugar changes and other information." It was said that technical director Jay Blahnik and Apple's health-focused development team have been working on the mysterious new product for more than two years.
As Apple gears up for an apparent 2017 launch, the report suggested the company is now tapping suppliers as it looks to finalize the product. On board are said to be Taiwan Semiconductor Manufacturing Co., Foxconn, TPK, Zhen Ding Technology, and more.
The report suggested that Apple's pressure sensing 3D Touch technology, found in the iPhone 6s, will play a crucial role in the new health product.
It claims that the new product, along with health sensing capabilities in the 2017 iPhone, could "set off a new whirlwind" within the technology industry.
The report was first discovered by Macotakara, which suggested Apple has developed a "revolutionary idea" with this new product that will somehow be related to its power supply.
No indication of a form factor for the device — whether it will be wearable or standalone — was given in translations of either report. But considering the rumor suggests it will be a first-generation device, it would seem that the new hardware will not be a more advanced version of the Apple Watch.
Over the last few years, Apple has been steadily building a health-focused team, including doctors, researchers and fitness experts. In addition to building new capabilities in the Apple Watch and iPhone, the team has been fleshing out developer-focused platforms like HealthKit, ResearchKit and CareKit.
Before he died, Apple cofounder Steve Jobs challenged his company to fix what he viewed as a disjointed healthcare system. Jobs believed technology could solve a gap between patients and healthcare professionals.Clearly the Apple Watch is a major part of that vision, but what form new health-focused hardware could take remains a mystery. One concept that's been tossed about are smart band accessories, optional add-ons for the Apple Watch that could add advanced functionality going well beyond the capabilities of the device itself, measuring blood oxygen, respiratory rate, blood pressure, and body temperature.
In addition, earlier this year Apple posted a new job opening seeking a lawyer with expertise in the U.S. Health Insurance Portability and Accountability Act. Apple's Privacy Counsel position advises on federal regulatory matters related to future products, suggesting the company plans to develop comprehensive medical technology beyond its current lineup, which includes as-yet-unregulated devices like the Apple Watch.
Tuesday, August 09, 2016
Ten years after the launch of the first iPhone, Apple could be planning to unveil a "killer new product" developed within its health laboratories, a new report claims — though details are vague.
As Apple gears up for an apparent 2017 launch, the report suggested the company is now tapping suppliers as it looks to finalize the product. On board are said to be Taiwan Semiconductor Manufacturing Co., Foxconn, TPK, Zhen Ding Technology, and more.
The report suggested that Apple's pressure sensing 3D Touch technology, found in the iPhone 6s, will play a crucial role in the new health product.
It claims that the new product, along with health sensing capabilities in the 2017 iPhone, could "set off a new whirlwind" within the technology industry.
The report was first discovered by Macotakara, which suggested Apple has developed a "revolutionary idea" with this new product that will somehow be related to its power supply.
No indication of a form factor for the device — whether it will be wearable or standalone — was given in translations of either report. But considering the rumor suggests it will be a first-generation device, it would seem that the new hardware will not be a more advanced version of the Apple Watch.
Over the last few years, Apple has been steadily building a health-focused team, including doctors, researchers and fitness experts. In addition to building new capabilities in the Apple Watch and iPhone, the team has been fleshing out developer-focused platforms like HealthKit, ResearchKit and CareKit.
Before he died, Apple cofounder Steve Jobs challenged his company to fix what he viewed as a disjointed healthcare system. Jobs believed technology could solve a gap between patients and healthcare professionals.Clearly the Apple Watch is a major part of that vision, but what form new health-focused hardware could take remains a mystery. One concept that's been tossed about are smart band accessories, optional add-ons for the Apple Watch that could add advanced functionality going well beyond the capabilities of the device itself, measuring blood oxygen, respiratory rate, blood pressure, and body temperature.
In addition, earlier this year Apple posted a new job opening seeking a lawyer with expertise in the U.S. Health Insurance Portability and Accountability Act. Apple's Privacy Counsel position advises on federal regulatory matters related to future products, suggesting the company plans to develop comprehensive medical technology beyond its current lineup, which includes as-yet-unregulated devices like the Apple Watch.
Wednesday, August 3, 2016
Pediatric office drops 8 families after negative Facebook comments
Written by Erin Dietsche
As eight Florida families can attest, be careful about what you write on social media. It could cost you more than you think, NBC 2 reported.
Approximately two weeks ago, one member of Supportive Moms of SWFL — a closed Facebook group with thousands of members — wrote a post highlighting the negative experience she'd had at Fort Myers, Fla.-based Island Coast Pediatrics. Sarah Rubio, another mom in the group, posted a comment about a similarly off-putting experience she'd had at Island Coast, where she's taken her kids for seven years.
A week after that, she got a letter saying her children had been dropped from Island Coast. "We find it necessary to inform you that Island Coast Pediatrics is withdrawing further medical care for your family... This decision is final and will not be discussed further or reversed under any circumstances," the letter read, according to the report.
Josefina Echeveste, Katie Gustafson and five others received similar letters. Ms. Echeveste added that she'd also posted positive comments about Island Coast pediatricians.
"I would like other mothers to know what we're all going through because of what we posted," Ms. Rubio said, according to the report. "An honest review turned out to be a disaster."
Currently, the American Academy of Pediatricians doesn't have any regulations that address situations like this, according to NBC 2.
As eight Florida families can attest, be careful about what you write on social media. It could cost you more than you think, NBC 2 reported.
Approximately two weeks ago, one member of Supportive Moms of SWFL — a closed Facebook group with thousands of members — wrote a post highlighting the negative experience she'd had at Fort Myers, Fla.-based Island Coast Pediatrics. Sarah Rubio, another mom in the group, posted a comment about a similarly off-putting experience she'd had at Island Coast, where she's taken her kids for seven years.
A week after that, she got a letter saying her children had been dropped from Island Coast. "We find it necessary to inform you that Island Coast Pediatrics is withdrawing further medical care for your family... This decision is final and will not be discussed further or reversed under any circumstances," the letter read, according to the report.
Josefina Echeveste, Katie Gustafson and five others received similar letters. Ms. Echeveste added that she'd also posted positive comments about Island Coast pediatricians.
"I would like other mothers to know what we're all going through because of what we posted," Ms. Rubio said, according to the report. "An honest review turned out to be a disaster."
Currently, the American Academy of Pediatricians doesn't have any regulations that address situations like this, according to NBC 2.
Tuesday, August 2, 2016
DeepMind’s first NHS health app faces more regulatory bumps
by Natasha Lomas
It’s fair to say that Google-owned AI company DeepMind’s big push into the health space via data-access collaborations with the UK’s National Health Service — announced with much fanfare in February this year — has not been running entirely smoothly so far.
But there are more regulatory bumps in the road ahead for DeepMind Health.
TechCrunch has learned the company won’t continue using one of the apps it co-designed with the NHS until the software has been registered as a medical device with the relevant regulatory body, the MHRA.
That’s especially interesting given that this app, called Streams, has already been used for patient care in multiple NHS hospitals. The Royal Free NHS Trust previously told TechCrunch the app had been used by up to six of its clinicians in three “user tests” in its London hospitals.
Which, put another way, means a profit-driven commercial entity has been involved in a real-world test of an unregistered medical device on actual hospital patients.
As TechCrunch previously reported, the Royal Free Trust stopped using the app in question in May, in the wake of another controversy pertaining to its DeepMind collaboration. At that point we learned the pair were contacted by the MHRA to discuss whether the app should be registered as a medical device.
A spokesman for the MHRA told TechCrunch at the time that regulatory compliance is helped by parties pro-actively having “a discussion” before going ahead with tests — something which did not happen in the DeepMind/Royal Free case.
It has now emerged that the upshot of those after-the-fact discussions is DeepMind believes it does need to register the app.
A spokesman for the regulator told TechCrunch: “MHRA understands that the Streams software is based on the NHS England AKI algorithm and is likely to be a class I medical device.
“As a class 1 device it is subject to self-declaration. The manufacturer of the device must hold all relevant test and validation data [including for software] to support the intended purpose for the device. The Competent Authorities within the EU (MHRA in the UK) can request to review all documentation pertaining to the device at any time.”
Announcing a second collaboration with another NHS Trust earlier this month, DeepMind’s co-founder Mustafa Suleyman took to Medium to write how treating NHS health data with respect “really matters”.
He went on to note: “There are different authorities that give different types of approvals and oversight for NHS data use: HSCIC, HRA, MHRA, ICO, Caldicott Guardians, and many, many more. We’re committed to working with all these groups, and making sure with their help that we get it right.”
Evidently DeepMind is going to need to rethink its modus operandi vis-a-vis pro-actively contacting the relevant healthcare regulators before it accelerates ahead with any more “user tests” powered by NHS data-sets.
Commenting on the latest development in its discussions with the MHRA, a DeepMind spokesperson told TechCrunch: “We’re still developing the prototype for the Streams app at this stage. We will of course ensure that it complies with all the applicable EU and UK medical device legislation before it is finalised, and we’re currently working with the MHRA on that basis. We would only place the Streams app on the market as a medical device after it had been fully certified, CE-marked and registered.”
“DeepMind is currently working with the MHRA to ensure that the device complies with all relevant medical device legislation before it is placed on the market,” a Royal Free spokesman added.
He confirmed the Trust remains “committed” to the app, although there is no word on when it might be used next.
At the time of publication the spokesman had also declined to confirm to TechCrunch how many patients the app was used on during those three “user tests” — so it’s impossible to verify the scope of the tests.
Both the Royal Free and DeepMind have maintained they have not yet run a clinical trial of the app in question, nor conducted a full on-the-market deployment — both of which would likely require them to first gain additional regulatory approvals.
But the question remains: at what point does a user test become a clinical trial? And without knowing the number of patients involved in these “user tests” how can we judge? The onus is therefore on the Royal Free to disclose that figure.
DeepMind’s first NHS collaboration, also with the Royal Free, also garnered early controversy when it emerged how extensive the data-sharing agreement between the two parties is.
Under a very broad data-sharing agreement, which includes five years of historical hospital inpatient data, DeepMind gains access to potentially millions of NHS patients’ identifiable medical records — and all without asking for patient consent to use their data.
The scope of the data-sharing arrangement has been criticized by health data privacy groups such as MedConfidential, which has questioned why DeepMind is being provided with so much identifiable patient data.
The app in question aims to speed up the identification of a condition called acute kidney injury, and the pair claim they need a wide range of patient data for it to function for this. Yet Caldicott Guidelines do appear to suggest that targeting a condition affecting groups of patients would be considered ‘indirect care’, rather than the ‘direct care’ relationship needed to rely on implied consent to access patient identifiable data.
Another DeepMind NHS collaboration, with Moorfields Eye Hospital in London, does not involve patient identifiable data — although the nature of the data being shared (detailed biometric eye scans) means it would hardly be impossible to link scans to individuals should there be a data leak.
In that instance around one million eye scans are being shared with DeepMind which will use the data to feed machine learning models in the hopes of being able to develop algorithms that can accelerate the identification of particular eye conditions.
While DeepMind is not currently charging the NHS for the work it’s doing in any of its publicly announced collaborations, it has confirmed it does intend to monetize the tools and systems it is building in future — and has also said it is exploring possible payment models based on performance outcomes.
Suleyman recently told the BBC: “Right now it is about building the tools and systems that are useful and once users are engaged then we can figure out how to monetise them.
“The vast majority of payments made to suppliers in healthcare systems are not often as connected to outcomes as we would like.
“Ultimately we want to get paid when we deliver concrete clinical benefits. We want to get paid to change the system and improve patient outcomes.”
So the reality is that the publicly funded NHS is freely providing health data-sets to a company that is using them to train machine learning models which, should they prove successful, could be used to bill the NHS in future — based on these trained models being more effective than alternative care options.
At present the Royal Free collaboration does not involve DeepMind applying AI to the data it is getting. But the pair have a wide-ranging memorandum of understanding in which DeepMind states its ambition to do so within the five-year initial timespan of the partnership.
Clearly the company has been moving very quickly in the health sector — and rather more quickly than certain NHS regulatory bodies would prefer.
(An ICO probe following criticism of the data-sharing arrangement between DeepMind and the Royal Free also remains “ongoing”, according to a spokeswoman.)
Given the accelerating pace of AI here, as I’ve said before, speed really is of the essence for the public to have a robust discussion about the rights and wrongs of handing profit-driven entities free access to publicly funded data-sets.
The reality is that very valuable publicly funded data-sets are being freely handed over to train AI models that might well in future be charging the same NHS for their services.
So the question remains whether we are comfortable with a freemium commercial model being leveraged to acquire advantageous access to taxpayer-funded data-sets.
And, ultimately, what is the true cost of free?
But there are more regulatory bumps in the road ahead for DeepMind Health.
TechCrunch has learned the company won’t continue using one of the apps it co-designed with the NHS until the software has been registered as a medical device with the relevant regulatory body, the MHRA.
That’s especially interesting given that this app, called Streams, has already been used for patient care in multiple NHS hospitals. The Royal Free NHS Trust previously told TechCrunch the app had been used by up to six of its clinicians in three “user tests” in its London hospitals.
Which, put another way, means a profit-driven commercial entity has been involved in a real-world test of an unregistered medical device on actual hospital patients.
As TechCrunch previously reported, the Royal Free Trust stopped using the app in question in May, in the wake of another controversy pertaining to its DeepMind collaboration. At that point we learned the pair were contacted by the MHRA to discuss whether the app should be registered as a medical device.
A spokesman for the MHRA told TechCrunch at the time that regulatory compliance is helped by parties pro-actively having “a discussion” before going ahead with tests — something which did not happen in the DeepMind/Royal Free case.
It has now emerged that the upshot of those after-the-fact discussions is DeepMind believes it does need to register the app.
A spokesman for the regulator told TechCrunch: “MHRA understands that the Streams software is based on the NHS England AKI algorithm and is likely to be a class I medical device.
Announcing a second collaboration with another NHS Trust earlier this month, DeepMind’s co-founder Mustafa Suleyman took to Medium to write how treating NHS health data with respect “really matters”.
He went on to note: “There are different authorities that give different types of approvals and oversight for NHS data use: HSCIC, HRA, MHRA, ICO, Caldicott Guardians, and many, many more. We’re committed to working with all these groups, and making sure with their help that we get it right.”
Evidently DeepMind is going to need to rethink its modus operandi vis-a-vis pro-actively contacting the relevant healthcare regulators before it accelerates ahead with any more “user tests” powered by NHS data-sets.
Commenting on the latest development in its discussions with the MHRA, a DeepMind spokesperson told TechCrunch: “We’re still developing the prototype for the Streams app at this stage. We will of course ensure that it complies with all the applicable EU and UK medical device legislation before it is finalised, and we’re currently working with the MHRA on that basis. We would only place the Streams app on the market as a medical device after it had been fully certified, CE-marked and registered.”
“DeepMind is currently working with the MHRA to ensure that the device complies with all relevant medical device legislation before it is placed on the market,” a Royal Free spokesman added.
He confirmed the Trust remains “committed” to the app, although there is no word on when it might be used next.
Both the Royal Free and DeepMind have maintained they have not yet run a clinical trial of the app in question, nor conducted a full on-the-market deployment — both of which would likely require them to first gain additional regulatory approvals.
But the question remains: at what point does a user test become a clinical trial? And without knowing the number of patients involved in these “user tests” how can we judge? The onus is therefore on the Royal Free to disclose that figure.
DeepMind’s first NHS collaboration, also with the Royal Free, also garnered early controversy when it emerged how extensive the data-sharing agreement between the two parties is.
Under a very broad data-sharing agreement, which includes five years of historical hospital inpatient data, DeepMind gains access to potentially millions of NHS patients’ identifiable medical records — and all without asking for patient consent to use their data.
The scope of the data-sharing arrangement has been criticized by health data privacy groups such as MedConfidential, which has questioned why DeepMind is being provided with so much identifiable patient data.
The app in question aims to speed up the identification of a condition called acute kidney injury, and the pair claim they need a wide range of patient data for it to function for this. Yet Caldicott Guidelines do appear to suggest that targeting a condition affecting groups of patients would be considered ‘indirect care’, rather than the ‘direct care’ relationship needed to rely on implied consent to access patient identifiable data.
Another DeepMind NHS collaboration, with Moorfields Eye Hospital in London, does not involve patient identifiable data — although the nature of the data being shared (detailed biometric eye scans) means it would hardly be impossible to link scans to individuals should there be a data leak.
In that instance around one million eye scans are being shared with DeepMind which will use the data to feed machine learning models in the hopes of being able to develop algorithms that can accelerate the identification of particular eye conditions.
While DeepMind is not currently charging the NHS for the work it’s doing in any of its publicly announced collaborations, it has confirmed it does intend to monetize the tools and systems it is building in future — and has also said it is exploring possible payment models based on performance outcomes.
Suleyman recently told the BBC: “Right now it is about building the tools and systems that are useful and once users are engaged then we can figure out how to monetise them.
“The vast majority of payments made to suppliers in healthcare systems are not often as connected to outcomes as we would like.
“Ultimately we want to get paid when we deliver concrete clinical benefits. We want to get paid to change the system and improve patient outcomes.”
So the reality is that the publicly funded NHS is freely providing health data-sets to a company that is using them to train machine learning models which, should they prove successful, could be used to bill the NHS in future — based on these trained models being more effective than alternative care options.
At present the Royal Free collaboration does not involve DeepMind applying AI to the data it is getting. But the pair have a wide-ranging memorandum of understanding in which DeepMind states its ambition to do so within the five-year initial timespan of the partnership.
Clearly the company has been moving very quickly in the health sector — and rather more quickly than certain NHS regulatory bodies would prefer.
(An ICO probe following criticism of the data-sharing arrangement between DeepMind and the Royal Free also remains “ongoing”, according to a spokeswoman.)
Given the accelerating pace of AI here, as I’ve said before, speed really is of the essence for the public to have a robust discussion about the rights and wrongs of handing profit-driven entities free access to publicly funded data-sets.
The reality is that very valuable publicly funded data-sets are being freely handed over to train AI models that might well in future be charging the same NHS for their services.
So the question remains whether we are comfortable with a freemium commercial model being leveraged to acquire advantageous access to taxpayer-funded data-sets.
And, ultimately, what is the true cost of free?
Friday, July 29, 2016
Paying doctors for referrals isn't very smart
By Lisa Schencker | July 28, 2016
South Carolina's Lexington Medical Center will pay the government $17 million over allegations that it paid 28 physicians unreasonably high amounts in exchange for referrals.
A whistle-blower and the government alleged that Lexington bought access to patients by acquiring physician practices and then paid the doctors “commercially unreasonable compensation” with the expectation that they would make referrals to Lexington.
Lexington, a 416-bed hospital in West Columbia, S.C., has denied any wrongdoing and said in a statement Thursday the settlement (PDF) allows it to avoid “continued costly litigation that could have lasted for several years.”
“While Lexington Medical Center was prepared to vigorously defend the case and to demonstrate why it believes the compensation paid to Lexington Medical Center employed physicians is in accordance with all laws and regulations, the outcome of this inquiry reflects the challenges hospitals face navigating highly complex employment law regulations for physicians,” Lexington said in the statement.
The government alleged that Lexington's actions violated the Stark law, which prohibits doctors from referring Medicare patients to hospitals, labs and other doctors that the physicians have financial relationships with unless they fall under certain exceptions.
The government alleged that the hospital's supposed Stark violations, in turn, led to the submission of tainted claims to the government in violation of the False Claims Act.
The lawsuit was originally brought by whistle-blower Dr. David Hammett, who was formerly employed by Lexington. In successful False Claims Act cases, whistle-blowers are entitled to a portion of whatever money the government is able to recover. Hammett will get about $4.5 million.
Hammett, a neurologist, was part of a practice that Lexington bought in 2011, and he became employed by Lexington then. He alleged that Lexington pressured him and others to refer patients for services at Lexington and fired him after he continued to refer patients to other providers for MRIs.
The Lexington settlement is one in a recent string of settlements between the government and providers over similar allegations.In September 2015, Florida-based North Broward agreed to pay the government $69.5 million for alleged violations of the Stark law and False Claims Act. North Broward did not admit to any wrongdoing.
Also in September of last year, Florida-based Adventist Health System settled a similar case for $118.7 million. Adventist said in a statement at the time it has changed its process for setting physician compensation and regretted oversights.
In October of last year, Tuomey Healthcare System in Sumter, S.C., agreed to settle with the government for $72.4 million, resolving allegations that it paid doctors for referrals.
Many have criticized the Stark law as overly complex and confusing, and a Senate committee held a hearing this month on the issue after releasing a white paper that said the Stark law has created “a minefield for the healthcare industry.”
Wednesday, July 27, 2016
Is BIG MEDICINE coopetition the answer for small medicine?
Arlen Meyers, MD, MBA
President and CEO, Society of Physician Entrepreneurs
President and CEO, Society of Physician Entrepreneurs
Published on July 27, 2016
As BIG MEDICINE gets bigger, the state of private practice is precarious and facing several existential threats. Regulatory, legal and IT mandates that don't work for small medicine further add to the burden.
While small medicine, independent, practitioners are gradually adapting, most have a "we v them" attitude and they are trying to carve out a niche based on varying business models and service excellence e.g direct primary care, using digital health technologies and pushing patient empowerment to improve the patient and doctor experience at lower cost.
As BIG MEDICINE gets bigger, the state of private practice is precarious and facing several existential threats. Regulatory, legal and IT mandates that don't work for small medicine further add to the burden.
While small medicine, independent, practitioners are gradually adapting, most have a "we v them" attitude and they are trying to carve out a niche based on varying business models and service excellence e.g direct primary care, using digital health technologies and pushing patient empowerment to improve the patient and doctor experience at lower cost.
More and more companies – from start-ups to incumbents– are taking a less literal approach to pursuing competitive advantage. They’re discovering untapped value potential by engaging industry rivals with a hybrid strategy of cooperation and competition, or “coopetition”. Coopetition can take many forms in sick care:
1. Integrating urgent care centers and retail based clinics into your care delivery model
2. Sharing information
3. A hybrid practice model where independent practices become part of a major integrated health system
4. Building cross referral relationships
5. Opportunities for educating and training medical students and residents
6. Translational research opportunities and human subject study patient recruitment
7. Finding common clients, like patients, and working together to lower costs or advance a mission
9. Cooperating to minimize inter-system hand off errors
10. Fighting unprofessional courtesies
Finding a middle ground is not just a practice strategy, but a policy strategy as well as we approach the November elections.
Fighting tooth and nail is one competitive strategy. "If you can't beat them, join them" is the other extreme. Coopetition might be a a reasonable and more practical middle ground.
Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs at www.sopenet.org and author of the free, updated Blogbook of Physician Entrepreneurship at www.hcplive.com/contributor/arlen-meyers-md-mba
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