A weekend potpourri of health tech news: mergers, cyber-ransom, Obama as VC?

As we approach what we in these less-than-United States think of as the quarter-mile of the summer (our Independence Day holiday), and while vacations and picnics are top of mind, there’s a lot of news from all over which this Editor will touch on, gently (well, maybe not so gently). Grab that hot dog and soda, and read on….

Split decision probable for US insurer mergers. The Aetna-Humana and Anthem-Cigna mergers will reduce the Big 5 to the Big 3, leading to much controversy on both the Federal and state levels. While state department of insurance opposition cannot scupper the deals, smaller states such as Missouri and the recent split decision from California on Aetna-Humana (the insurance commissioner said no, the managed care department said OK) plus the no on the smaller Anthem-Cigna merger are influential. There’s an already reluctant Department of Justice anti-trust division and a US Senate antitrust subcommittee heavily influenced by a liberal think tank’s (Center for American Progress) report back in March. Divestment may not solve all their problems. Doctors don’t like it. Anthem-Cigna have also had public disagreements concerning their merged future management and governance, but the betting line indicates they will be the sacrificial lamb anyway. Healthcare Dive today,  Healthcare Dive, CT Mirror, WSJ (may be paywalled) Editor’s prediction: an even tougher reimbursement road for most of RPM and other health tech as four companies will be in Musical Chairs-ville for years.

‘thedarkoverlord’ allegedly holding 9.3 million insurance records for cyber-ransom. 750 bitcoins, or about $485,000 is the reputed price in the DeepDotWeb report. Allegedly the names, DOBs and SSNs were lifted from a major insurance company in plain text. This appears to be in addition to 655,000 patient records from healthcare organizations in Georgia and the Midwest for sale for 151 – 607 bitcoins or $100,000 – $395,000. The hacker promises ‘we’re just getting started’ and recommends that these organizations ‘take the offer’. Leave the gun, take the cannoli.  HealthcareITNews  It makes the 4,300 record breach at Massachusetts General via the typical unauthorized access at a third party, once something noteworthy, look like small potatoes in comparison. HealthcareITNews  Further reading on hardening systems by focusing on removing admin rights, whitelisting and endpoint security. HealthcareDataManagement

Should VistA stay or go? It looks like this granddaddy of all EHRs used by the US Veterans Health Administration will be sunsetted around 2018, but even their undersecretary for health and their CIO seem to be ambivalent in last week’s Congressional hearings. According to POLITICO’s Morning eHealth newsletter, “The agency will be sticking with its homegrown software through 2018, at which point the VA will start creating a cloud-based platform that may include VistA elements at its core, an agency spokesman explained.” Supposedly even VA insiders are puzzled as to what that means, and some key Senators are losing patience. VistA covers 365 data centers, 130 separate VistA systems, and 834 custom installations, and is also the core of many foreign government systems and the private Medsphere OpenVista. 6/23 and 6/24

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/01/Overrun-by-Robots1-183×108.jpg” thumb_width=”150″ /]Dr Eric Topol grooves on ‘The Fourth Industrial Revolution’ of robotics and AI. (more…)

Silicon Valley’s betting on ‘citizen doctors’, ‘citizen science’ and useful data

A fascinating and slightly cynical overview of Silicon Valley’s ideological view of health tech that will fix our ‘deeply flawed healthcare system’ and what is getting funded (or not) is in next month’s San Francisco magazine. It profiles the ‘citizen doctor’ founders of vital signs ‘tricorder’ Scanadu (Sam–who’s not often mentioned–and Walter De Brouwer), bacteria tracker uBiome, ‘personal data recorder’ and experience charter We Are Curious (founded by Linda Avey, a long-departed co-founder of 23andme) and touches on the Theranos debacle. While these stories are bracing and in the instance of the De Brouwers, courageous, the notion of ‘citizen science’ (defined as direct-to-consumer health data) and its companion, Dr Eric Topol’s patient-centered/controlled medicine, has its drawbacks, viewed through the slightly gimlety ‘digital doctor’ eye of UC San Francisco’s Dr Robert Wachter. “The overarching message—not just from Theranos but from other companies struggling to get a toehold—is that, ultimately, the laws of economic gravity hold. The companies will have to produce products that add real value, either to patients or to payers. If they don’t, the market—or the regulators—won’t treat them kindly.” Flatly, there aren’t enough Quantified Selfers right now to support these companies. And Mr Market is a hard master. 23andme is back in the good graces of the FDA after a two-year scuffle and back doing direct response TV here in the US. Scanadu’s two products, Vitals (formerly Scout) and Urine are still not through the long slog of FDA clearance. The jury’s out on Theranos. And all these companies, including ‘unicorn’ Theranos, are bleeding cash and nowhere near turning a profit. ModernLuxury. Hat tip to Dr Topol via Twitter, who had a patient-centered conversation with Dr Wachter that we covered back in September.  Another recent podcast with Dr Wachter is here (Community Health Center radio).

Update: ‘Citizen science’ is nothing new, as revealed by the Science Museum (London)–it’s over 300 years old. While it entered the OED in 2014, ‘in 1715, Edmund Halley used Philosophical Transactions to ask colleagues to help him observe a total solar eclipse, prompting observers from all over the country to respond.’ Other examples are from Benjamin Robins in the same publication in 1749 on fireworks, Charles Darwin and evolution, to the present day. The difference is the flow–similar to what we now call crowdsourcing versus the individual using the data to affect their care.

 

FDA Workshop: Collaborative Approaches to Medical Device Cybersecurity

20-21 January 2016, FDA White Oak Campus, Silver Spring Maryland

Attend this free and public two-day workshop hosted by FDA on cybersecurity and medical devices highlighting “past collaborative efforts, increase awareness of existing maturity models (i.e. frameworks leveraged for benchmarking an organization’s processes) which are used to evaluate cybersecurity status, standards, and tools in development, and to engage the multi-stakeholder community in focused discussions on unresolved gaps and challenges that have hampered progress in advancing medical device cybersecurity.” Registration required (information and form here), but there is also a webcast (link available after 13 Jan) if you cannot make it to FDA.

Is Theranos’ ‘blood testing for all’ a responsible selling proposition?

Theranos’ recent troubles on their blood testing (Walgreens halting expansion, FDA halting nanotainers as ‘uncleared medical devices’ and last week chain grocery/drugstore Safeway dropping their $350 million deal for 800 locations) have been well covered in media both here and elsewhere. But what if their Unique Selling Proposition–that people should have the ‘basic human right’ to order up their own inexpensive blood tests and then be responsible for their own interpretation–is counter-productive for many patients? After all, it’s what Theranos has been organized and raised $400 million+ on. Dr Robert Wachter of UCSF, who is no top-down Ezekiel-esque ‘nanny stater’, lends a caution: “There are a lot of companies, including Theranos, that have an interest in making you believe that more data will magically make you healthier. It won’t, at least not in the short-term.” When is ’empowerment’ confusing without recourse to interpretation? Some results are easier to read than others. Does having the data make the average person healthier for real? Personally, this Editor would welcome the ability to walk into her local Walgreens and order up a few to see what’s up–but then again she can do her own research and ask a doctor or nurse to help. Who can (inexpensively) close the interpretation gap? Theranos is wrapped in scandal but goes hard to change laws to its advantage (Mashable)

Theranos/FDA update: nanotainers are ‘uncleared medical devices’

And the battering of their USP continues. On the heels of Walgreens Boots Alliance (which this week proposed a merger with #3 Rite Aid to create the largest by location US drugstore chain) putting a screeching halt on expanding its 41 Theranos testing locations, the FDA has told Theranos that its nanotainers are actually ‘uncleared medical devices’ which further violate because they are being shipped over state lines. The company was also scored on handling complaints poorly, keeping poor records and failing to conduct quality audits including on the manufacture of the nanotainers. These were revealed on redacted FDA Form 483s filed as a result of a month-long inspection ending in mid-September, which were published per a Freedom of Information Act (FOIA) request. According to MedCityNews, the nanotainers were mistakenly classified as Class I and not II. Fortune quotes one of the reports: “The design was not validated under actual or simulated use conditions,” (more…)

FDA’s ‘ossification tango’ side 2: what’s the social cost?

Catching up in the back file of articles is another in Bradley Merrill Thompson’s (Epstein Becker Green) series in Mobihealthnews on how the FDA is biased, by its very structure, against novel healthcare technology even if low risk. He further reflects on what’s truly novel, and what’s not. ‘Novel’ means Class III clearance and potentially millions of dollars. to gain it. He reckons that 80 percent of new digital health technology doesn’t qualify as ‘new’ in a regulatory sense–it may be ingenious in transferring the color reading of a test strip to, for instance, a smartphone and an analytic back end. All the new technology has to do is to demonstrate equivalence to the clunky traditional test–in other words, incremental improvement. What he’s worried about is the 20 percent that don’t fit any FDA classification, in particular software that automates what professionals do, repurposing non-healthcare technology for healthcare use (e.g. videogames for ADHD) or algorithms that automate what’s been done manually through a different method. The social cost is that the most in need, who would benefit from novel health tech that cuts cost and improves quality for individuals and populations (that old Triple Aim), will forever be blocked from having it by regulation. “We need a new paradigm where new technology is quickly evaluated for potential risk, and placed promptly into an appropriate regulatory category.”

There are certainly regulatory parallels ex-US. Much more here to ponder for your Weekend Reading.

Previously and related by Mr Thompson: Avoiding the FDA health IT-medical device regulatory trap for general IT companiesFDA, new technology approval and the Ossification Tango

23andMe returns to direct-to-consumer genetic testing marketing

Nearly two years after the FDA shut the door on 23andMe‘s direct marketing of genetic testing, it is now back in the market with FDA clearance. The new Personal Genome Service (PGS) now meets FDA standards–and is now $199 where it was previously $99. It is as before a saliva-based test that in about two months, provides that person with an online report. There are multiple types, for instance the carrier status test on 36 inherited conditions, including cystic fibrosis and sickle cell anemia. The company is also bolstered by closing a $115 million round this month and in January a partnership with Pfizer to sell the company its Research Portal aggregated, anonymized data. Earlier this year, FDA cleared in Class II their Bloom Syndrome test [TTA 20 Feb] and late last year resumed DTC test marketing in the UK. Mobihealthnews also includes a helpful timeline of 23andMe’s troubles and recovery.

Blood is drawn: Theranos responds vigorously to TTA re WSJ

From his very first interactions with Theranos, the reporter made abundantly clear that he considered Theranos to be a target to be taken down, and not simply the subject of an objective news story. The articles that appeared last week are the inevitable product of that approach.–Theranos Facts, 22 Oct

Breaking news. Blood is drawn. A spokesperson for Theranos (from FTI Consulting), Ms Shea Maney, has responded directly to this Editor regarding the content of the Wall Street Journal article, previously covered here (The $9 billion question mark) along with followup in primarily Fortune but also commentary in the Health Care Blog. Her note to me (which undoubtedly has gone to other press) is reprinted below in its entirety, save the standard closing line:

We read your coverage of Theranos with interest, and noticed you were particularly interested in accuracy and our finger-stick tests, among other themes. There have been a lot of inaccuracies in the coverage of these topics, which is why we have posted detailed information on our technology, accuracy, and conversations with The Wall Street Journal on our website: https://www.theranos.com/news/posts/custom/theranos-facts

On accuracy: Theranos’ technology is reviewed by regulators, proven in the field, and praised by leaders in the industry and doctors and individuals that we serve. We are confident in the reliability of our tests, because we have validated their accuracy. (more…)

FDA, new technology approval and the Ossification Tango (US)

When it comes to new technologies–and drugs for that matter–the worst thing that can happen to your invention is to receive a letter from FDA that you have been classified into Class III. Based on regulations passed by Congress in 1976, there are three FDA classes primarily based on device risk. Exception: Class III. Anything not ‘substantially equivalent’ to an existing device is automatically put into Class III, regardless of risk level. Author and health tech legal advocate Bradley Merrill Thompson of Epstein Becker Green takes a comprehensive review at this flawed and outdated system that puts groundbreaking health tech at an extreme disadvantage in his latest article on regulation in Mobihealthnews. (more…)

Avoiding the FDA health IT-medical device regulatory trap for general IT companies (US)

If you are an IT company in the US or internationally with services which could be useful to healthcare companies or practitioners, it’s easy to be overly specific and stray into FDA-regulated territory. The always-informative Bradley Merrill Thompson of the Epstein Becker Green law firm delineates the fine regulatory line that general purpose IT companies must observe when working with healthcare customers. First there is intended use, based on how the manufacturer intends its customer to use the product; if the customer uses it for the diagnosis or treatment of disease or other conditions, FDA will regulate it as a medical device. This is less clear than it seems, and Mr Thompson explores where a general IT company can, in the old PR adage, ‘say it safely’ and avoid falling into the unwanted medical device trap by avoiding medical feature and advice claims, and keeping the context away from medical use. The Journal of mHealth (August)–online version, optional PDF download. Hat tip to Mr Thompson via the Continua LinkedIn group. Other articles of interest in the JMH are: Scottish company HCi Viocare and its ‘smart insole’ pressure sensors for foot ulcer detection following, Northwestern University’s research around patterns of smartphone usage detecting depression (page 19) and a lengthy article on transforming patient data into actionable insights (page 34).

Pharma company ‘breaks the Internet’ with Kim K, gets FDA testy

But it may break them…well, give them a fracture. Or a good hard marketing lesson. Specialty pharma Duchesnay thought it had hit the jackpot with negotiating a promotional spokeswoman endorsement from pregnant celebrity Kim Kardashian of its morning sickness drug Diclegis. The Kardashian Marketing Machine cranked up. Kim (and mom Kris Jenner) took to Instagram, Facebook and Twitter in late July with (scripted) singing of Diclegis’ praises to their tens of millions of followers. The Instagram posts linked to an ‘important safety page’ a/k/a The Disclaimers. That wasn’t near enough for the Federal Drug Administration (FDA) which governs the acceptable marketing of all drugs in the US. On August 7th a tartly worded letter arrived at Duchesnay’s Pennsylvania HQ cited multiple violations of marketing regulations, notably risk information, and told Duchesnay to cease these communications immediately or withdraw the drug, which would be highly unlikely as it is successful. They also were require to provide “corrective messages” to the “violative materials”.

Our takeaway:

* Duchesnay reaped a bounty of free media (see below), on top of the (undoubtedly expensive) Kardashian endorsement. Yes, they did pay the cost of a FDA nastygram and a legal response, and the warning will live on in their file. However, a lot of target-age women now know Diclegis and others know about the relatively obscure Duchesnay.

* This was a calculated marketing risk that tested the boundaries of social media and celebrity endorsement. (more…)

Smartphone and sensors the latest ‘medic’ for diagnosing battlefield TBI

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/07/Ahead-200.jpg” thumb_width=”150″ /]Finally a more reliable device for combat medics to screen for TBI in the field. The US Department of Defense, before its EHR bombshell (so to speak) yesterday, issued this short Armed With Science article on a sensor-smartphone for quick field diagnosis of TBI. The FDA-cleared BrainScope Ahead 200 marries an Android smartphone with a headset and disposable sensors to measure brain electrical activity, The app in the smartphone then analyses the brain data using algorithms to correlate them to elements relating to TBI. Currently, most combat-related TBI tests are subjective, based purely on symptoms such as headaches, nausea and light sensitivity. The only ‘objective’ test would be a CT scan in a medical facility well off the front lines, which means time wasted in a definitive diagnosis. This is being implemented by the Army Medical Research and Materiel Command at Fort Detrick, Maryland.

Do startups truly threaten the ‘healthcare establishment’?

Or are successful startups fitting into their game? Chris Seper in MedCityNews paints the picture of one side of a quandary. The ‘healthcare establishment’ fundamentally and to its detriment does not understand and is threatened by the startup and innovation process. A startup may begin with an idea which is, in his words, ‘almost always flawed, sometimes deeply’. If the founders are smart, they will test their ideas, validate them and change them appropriately. If not, they will fail. But it is easier for the Establishment to point at the most egregious of the bad ideas and use them to rationalize the status quo.

But being congenital contrarians, we paint the house on the other side of the street. Has the Establishment caught up with–or in some cases, co-opted startups, making them and their funders ‘do their diligence’ and be more cautious before emerging? This Editor would argue yes, and largely for the better.

**The ‘Wild West’ days are over. A few years ago, a truly bad or deeply flawed health tech idea or could easily find funding, because it was all blank slate, new and ‘transformative’.The sexiest hooks were Quantified Self, sleep, employer health incentives, interactive coaching, genomics, app prescribing and (last) wearables. A lot of founders imagined themselves as the Steve Jobs of Healthcare, down to the black turtleneck. Now there is a history of success and failure. The railroads reached the dusty frontier towns.

**There’s now a ‘Startup Establishment’. National accelerators (more…)

‘Separating the wheat from the chaff’ in medical apps daunting: JAMA

Medical apps may not be strangers to doctors’ offices anymore but they also realize that apps are difficult to recommend responsibly to patients or even to find, because there is no real guidance or validation. This current article in JAMA online confirms the perception and the need for care integration that both Editors Charles especially and Donna have pointed out lo these many years. However this Editor is quite disillusioned at the attempts to date to ‘curate’ apps with the Happtique failure and the relatively low profile to date of IMS Health’s AppScript and professional review site iMedical Apps and the stated intentions of SocialWellth which purchased Happtique. The reality is that the numbers are against it–IMS Health in their study estimated 40,000 medical apps–in 2013. For apps that want to take the high road, it’s economically difficult, but could be rewarding in the long term. The WellDoc BlueStar diabetes tracking and management support app did with FDA clearance and prescription-only use, but few so far can see a revenue model there. Also MedCityNews.

Intended use determines degree of health app regulation–and also how you communicate your attributes and performance claims. Bradley Merrill Thompson, who performs an invaluable service by advising our field on regulation, compliance and interacting with FDA, demonstrates how a developer can determine where the intended use of an app might fall (more…)

HIMSS Monday highlights

HIMSS is the largest US healthcare conference in the world, and Neil Versel, who has just joined the staff of MedCityNews, reported that registrations in this year’s event in Chicago were in excess of 40,000. He has a 37 minute interview with HIMSS Executive Vice President Carla Smith where they touch on CMS, Meaningful Use, EHR interoperability, data security, patient engagement and the empowered patient such as E-Patient Dave deBronkart (who will also be at The King’s Fund Digital Health conference in June). HIMSS is also showcasing on the show floor mobile health, interoperability, cybersecurity, disaster preparedness, intelligent health and the connected patient….Another sign that the Wild West days of digital health are over is the increasing oversight of the Federal Trade Commission (FTC) on non-HIPAA regulated health data collected by fitness and wellness devices. This is in addition to health apps making unsupported claims (see today’s and previous articles on melanoma detection apps) and the PaymentsMD patient billing software that was collecting a little extra patient data. This is both extra- and in addition to FDA. Mobihealthnews….. The Venture+Forum on Sunday discussed doctor burnout particularly in acute care and to ease this, focusing on the Holy Grail of proactive rather than reactive care and results rather than ‘shiny new objects’ (what this Editor has called Whiz-Bang Tech) “Doctors want clinical decision execution. Don’t give me any more tools.” Healthcare IT News….A survey by Accenture released today on doctors and EHR usage headlines good news–79 percent US doctors feel more proficient in their EHR usage than in their 2012 survey. The bad news is that other numbers are plummeting: fewer believe that EMR has improved treatment decisions (46 percent in 2015 vs. 62 percent in 2012), reduced medical errors (64 vs. 72 percent) and improved health outcomes for patients (46 vs. 58 percent). Familiarity breeds contempt? Buried way down in the release is that US physicians offering telehealth monitoring to patients has tripled since the last survey, from just 8 percent in 2012 to 24 percent now. Accenture surveyed over 2,600 physicians in six countries….HIMSS goes to Thursday, so more to come!

23andMe’s FDA coup hazardous to personal DNA data security?

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/03/DNA-do-not-access.jpg” thumb_width=”150″ /]Genetic test developer 23andMe’s wins with the FDA [TTA 20 Feb] served to clear the path for their current Bloom Syndrome and future kits as Class II devices. It’s long been believed that the company’s real diamond mine is in selling the DNA data gained through the kits, and with consent, to major pharma and medical companies. Proof: recent collaboration announcements with Genentech and Pfizer on genetic research. But how will this data be safeguarded? It may not be a significant concern now, but “Personal DNA information will become far more critical and more important to safeguard than the details of our life circumstances”. Hackermania’s Running Wild with AnthemHealth-sized data breaches (more…)