Parkinson’s disease monitoring app promising for advanced clinical decisions

click to enlargeA study in the July Journal of Parkinson’s Disease presents a small (N=40) study on the use of wearable sensor data and the KinesiaOne mobile app to assist in clinical decisions around advanced therapy referral for Parkinson’s disease patients. The KinesiaOne sensor is worn on the fingertip and tracks motor response on the mobile app (left). The patients were followed for one year, with half receiving standard care and half using motion sensor-based remote monitoring once per month in conjunction with standard care. Remote monitoring led to five times more advanced therapy patient referrals, compared to standard care alone (63.6 percent versus 11.8 percent, p <  0.01). These therapies are highly considered due to their nature–deep brain stimulation (DBS) or an implantable medication pump–and this initial screening may lead to more advanced algorithms and/or continuous monitoring, which the KinesiaOne developer, Great Lakes NeuroTechnologies, also has. Release, JPD abstract, Mobihealthnews Also see our short article on Ireland’s Beats Medical.

The Theranos story, ch. 17: closing the barn door after the horse

click to enlarge And it may work, though the horse is in the next county. Late last week, with American eyes elsewhere, Theranos announced that they hired two executives with regulatory responsibility–a chief compliance officer and an VP regulatory and quality–and formed a new board committee focused on same. The CCO is Dave Guggenheim, the former assistant general counsel for regulatory law at HIT/medical distribution giant McKesson. The VP, Daniel Wurtz, comes from a similar senior director position at biotech Thermo-Fisher Scientific.

The country maxim, ‘closing the barn door after the horse has bolted’, applies. In fact, the horse is in town and having a growler of beer at the local tavern. The Newark, California lab is shut and the principals, including the CEO Ms Holmes, are technically prohibited from operating a lab for at least two years (that means you, Ms Holmes) starting in a month. Messrs Guggenheim and Wurtz (or similar) should have been on board years ago. Even small companies in our field realize they HAVE to do this!

This also doesn’t affect the interesting interest that DOJ and SEC have in Theranos. [TTA 10 July]

However, this Editor will take the contrarian view that somehow, some way, the ‘fix’ is being worked out, if not in. Don’t make reservations for the fire sale quite yet. The ban on Ms Holmes won’t take place for another month, minimum. That gives time for David Boies, their legal supremo, and his firm to stall for more time, and time for some calls to ask favors from friends, of which he has many in this administration. More than likely, Boies on behalf of Theranos will appeal the CMS rulings to an administrative judge. Ms Holmes may take the hit, but may get a handsome payday to depart despite her reported control, if the investors can salvage something out of the company.

At HQ, they may be rehearsing saying ‘mea culpa, mea culpa, mea maxima culpa’ three times, kneeling deeply, in preparation to Going Forth And Sinning No More.

The Object Lessons taught by the Theranos Troubles, to us in healthcare tech, continue.

WSJTheranos Hires Compliance, Regulatory Executives  (more…)

Three Ireland health tech startups profiled

Liesel Butterfield, a young marketer/business development exec with Enterprise Ireland, focuses on three young companies with investment from EI:

  • Beats Medical: an app that delivers metronome sound wave therapy, reminders and assessments to Parkinson’s disease patients. The principle is cueing and auditory stimulation which has been proven to aid these patients in maintaining mobility, reducing symptoms and a characteristic freezing of gait. In 2013 it was an Enterprise Ireland high-potential startup. Founder Ciara Clancy  was named Laureate for Europe at the Cartier Women’s Initiative 2015. HQ in Dublin and London.
  • DocLink is an app with a secure document management system which enables communications of text, video and images between doctors globally. It also has a newsfeed/forum that tailors information by specialty. HQ is near Dublin.
  • Ayda is an app with a sensor device that adheres to your underarm . Its primary use is highly targeted to female fertility tracking. In pre-market, HQ’d in Cork and San Francisco.

LinkedIn Pulse. Hat tip to Liesel.

Digital health dates for Autumn 2016

Fancy a startup in Barcelona? Look no further than the NUMA Barcelona Accelerator. Note entries needed by 25th September.

The Biomedical Catalyst 2016 early stage award competition requires registrations by 7th September, applications in by 14th September.

The European Commission has opened a public consultation on the safety of apps and other non-embedded software as part of an effort to ensure a high level of health, safety and consumer protection. Be sure to respond by closing date of 14th September.

Baker Botts, the international firm of lawyers specialising in intellectual property has very kindly agreed to continue to support the London Health Technology Forum which has now agreed three evening events this autumn, on 15th September, 20th October & 24th November. The programmes are (more…)

DOJ sues to derail Aetna-Humana, Anthem-Cigna mergers on anti-trust grounds (updated)

Breaking News. The anticipated shoe has dropped. With all the US news concentrating on the Republican convention, the US Department of Justice, late today, without much fanfare beyond the presser, lobbed lawsuits at Aetna and Anthem to stop their respective acquisitions of Humana and Cigna. US Attorney General Loretta Lynch was joined by Principal Deputy Associate Attorney General William Baer, who had been the DOJ’s point person for this anti-trust review.

According to CNN’s report, Mr Baer said “the two mergers would leave consumers at risk by reducing benefits and raising premiums. He also stressed that the most vulnerable would be hit the hardest and that competition would be reduced. “These are so-called solutions that we cannot accept,” Baer said. He added that the mergers are a “convenient shortcut to increase profit for these two companies,” and that the DOJ had “zero confidence” that they would benefit consumers.”

Reuters reported that Aetna and Humana expect “to vigorously defend the companies’ pending merger,” Anthem’s response was “more muted”, as industry observers expected, as it has been more problematic not only in size and with Medicare Advantage divestiture, but also with reports of disagreements on management and governance.

If these mergers were successful, the Big Five in US health insurance would be reduced to the Big Three, with the $48 bn Anthem-Cigna matchup besting UnitedHealthCare for the #1 pole position with 45 million covered persons.

Why is this important to those of us in telehealth, telemedicine and telecare? We are still seeking ‘who pays for it’ (remember our Five Big Questions/FBQs?) and when five becomes three, and things are unsettled….negotiations grind to a halt. (This Editor will reference the post-2008 years where health tech US deals and development came to a screeching stop as we waited to find out what was in that mystery ACA bill. Recovery/reset took years….)

Earlier reports via Bloomberg News and Reuters noted that both sets of insurance companies faced substantial opposition from the start. (more…)

The Theranos Story: now as a cartoon strip, not so ‘funny as a heart attack’ lawsuit

click to enlargeThe absolutely funniest take that this Editor has seen is a funny paper–literally a (scroll down) cartoon strip that serializes the Theranos story. ‘The Rise and Fall of a Health Care Tech Unicorn’ lampoons CEO Holmes’ dropping out of Stanford, the Rube Goldberg-esque (=UK Heath Robinson) Edison Machine to the Wall Street Journal Exposé. $9 billion to $9. Depicted by Fiore for KQED San Francisco’s Future of You blog.

Unfortunately, for one now-plaintiff, Theranos isn’t funny at all. According to a lawsuit filed Monday in the US District Court in Arizona against both Theranos and Walgreens Boots Alliance, the patient’s doctor-ordered blood lipid and sugar levels came back normal. Based on these results, the doctor recommended remaining with ‘R.C.’s  medication regimen. Less than one month later, R.C. suffered a heart attack, requiring surgery to implant two stents in his arteries. The additional blood testing led his doctor to believe that the Theranos results were dangerously inaccurate. These were the same results which were voided in May [TTA 19 May]. This is the ninth lawsuit over Theranos’ testing.

The sanctions which will close Theranos’ labs and prohibit Ms Holmes from the lab testing business will take effect 5 September, according to Ars Technica. (Article includes PDF of the court filing)

PwC finding that VC funding down–and up–depending on your sector

Bad news, good news. It depends on where you and your company sit. Pricewaterhousecoopers and the National Venture Capital Association (NVCA) have been tracking VC activity for several years based on Thomson Reuters data. They found the total 2nd Quarter versus 1st Quarter startup funding picture uneven, with 2nd quarter funding increasing by
20 percent but with total number of deals down 5 percent, versus $12.7 billion and 1,011 deals in 1st quarter.

  • Biotech was gloomy despite being the #2 VC funding category: $1.7 billion invested into 100 deals, representing a 14 percent decrease in dollars and a 19 percent decrease in deals
  • Life Sciences, which combines biotech and medical devices and accounts for 15 percent of all VC funding to startups, rose to $2.2 billion going into 161 deals, but investment decreased 10 percent and 12 percent in deals.
  • Healthcare Services notched a 65 percent increase to $218 million and 21 deals, but this category is only 1 percent of total investment

 

PwC website and interactive chart; press release (PDF)  Also MedCityNews.

Minimally disruptive medicine: a two-day intensive course at Mayo Clinic

The concept of ‘minimally disruptive medicine’ is not mainstream, but should be. MDM is designed to fit the treatment to the patient. In chronic conditions, often the expectation of the doctor, practice and hospital is to do too much. After all, there is the relentless drive to value-based care that improves outcomes and reduces costs that has at its core the absolutely relentless monitoring of delivery metrics and patient compliance (take that med, even if you can’t keep your dinner down). The frustration of the patient with chronic conditions is palpable; it’s not understood, or it’s all too much to handle. We last covered Dr Victor Montori a year ago and in 2013 as proposing that we’re thinking about patients in chronic care management all wrong; that we need to fit the treatment to the patient in order to simplify actions they need to take, to reduce the burden of illness and gain a better outcome. The two-day intensive is at the Mayo Clinic in Rochester, MN, 27-29 September. Registration here. YouTube preview video.

The global ‘state of telehealth’ according to Dr Topol: work in progress

Are we approaching a ‘tipping point’ in telehealth and telemedicine within 5 to 10 years? While telemedicine (doctor-patient, hospital-hospital video consults) and even telehealth (patient monitoring generally at home) are becoming more common, Drs Eric Topol and E. Ray Dorsey see the tip coming within the decade in their New England Journal of Medicine (NEJM July, subscription required) article, moving from the early adopters to the majority. But there are still substantial barriers: interstate licensing, fragmented care, spotty state and Federal reimbursement including Medicare, wireless coverage enabling mobile monitoring, the future of the doctor-patient relationship, even the potential for narcotic abuse. They also need to move into the private sector. Somewhat misleading are the 2 million telehealth visits counted by the Veterans Health Administration; it includes the larger programs in store-and-forward information transfer and clinical video consults versus in-home telehealth.

Three trends they see paving the way to ubiquity:

  1. Moving beyond providing access to being driven by convenience and reducing cost
  2. Not just for acute conditions, but for monitoring chronic and episodic conditions (although vital signs monitoring, which is the core meaning of telehealth, has been doing so since the early 2000s)
  3. Migration from hospitals and satellite clinics to in-home and mobile applications

While the two doctors caution on risks, including breaches, they see telemedicine and telehealth increasing the delivery of care in the next ten years and spreading globally. Healthcare Informatics, Qmed

Avizia talks Telemedicine Down Under

Telemedicine startup Avizia, which revealed last week its $11 million Series A fund raise, has been promoting itself through a webinar series. Unusually for a US company, it has presented panels discussing telemedicine in Canada and this month, Australia. (It also has operations ex-US in Australia and UK, and was a sponsor of SFT-15 in Brisbane last November.) The panelists were Dr. Victoria Wade (University of Adelaide), Dr Anthony Smith (University of Queensland) and Dr Sisiri Edirippulige (Queensland). Topics discussed in the hour webinar were:

  • Aging population with increased rates of chronic diseases
  • Density of care providers in urban areas, but 1/3 of the Australian population lives in rural communities
  • Government funding for telehealth video consultations
  • Incentives to expand or develop new telehealth programs
  • Increased familiarization with the technology; expectations are changing on how to obtain care

The recorded webinar is available here.

Ka-ching! $61 million to telemedicine’s Teladoc, Avizia

Two ends of the spectrum. Teladoc, now reputed to be the largest telemedicine company in the US, can now access $50 million in new capital via a $25 million term loan and a $25 million revolving line of credit from Silicon Valley Bank. This is just after announcing the purchase of mobile-app-based physician locator HealthiestYou in a $125 million deal ($45 million in cash + 6.96 million shares of its common stock valued at $80 million.) Teladoc has been on a roll since 2008, with $245 million in funding up through 2015 (Accenture).

Telemedicine startup Avizia, on the other hand, closed a healthy $11 million Series A round from Blue Heron Capital (as lead–CrunchBase) and then announced a partnership with video provider Vidyo to be compatible with their addressable video platform. From a start in telemedicine carts, Avizia now has new apps for mobile devices and secure messaging for doctors within hospitals. Modern Healthcare, MedCityNews

Asia-Pacific telehealth set to grow to 75% to $1.79 billion in 2020: Frost study

Frost & Sullivan’s Asia-Pacific Telehealth Outlook 2016-2020 is projecting that telehealth (broadly defined as telemedicine, remote patient monitoring (RPM) and mobile health), will be growing from US $1.02 bn in 2015 to $1.79 bn by 2020. Driving growth in the region are an aging population, governments building out 3G/4G mobile networks and developing favorable policies and roadmaps. However, the study found that impediments included a familiar tune of poor clinician adoption, unfavorable regulations, lagging technology and (ta-da) payment models. What’s improved? Wearables in the region have made great strides, and payment models, according to F&S, are concentrated on patient and provider pay. Not so familiar is that many Asia-Pac nations are building a Smart Cities and Smart Nation infrastructure; telehealth is a key area almost always included in a Smart City plan. The study will set you back a smart $4,950. Marketwatch release. F&S feature page.

Why do hackers love bitcoin? Blockchain. And why are healthcare, IoT liking blockchain?

Hackers love bitcoin for their ransomware payment because it’s virtual money, impossible to trace and encrypted to the n-th degree. Technically, bitcoin is not a transfer of payment–it IS money of the unregulated sort. The ransomee has to pay into a bitcoin exchange and then deliver the payment to the hacker. However, what sounds straightforward is actually fraught with risks, such as the bitcoin exchanges themselves as targets of hacking and the fluctuations of bitcoin value meaning that a ransom may not actually be paid in full. ID Experts‘ article gives the basics of bitcoin, what to expect and when paying a ransom is the prudent thing to do.

click to enlargeTurn what is behind bitcoin around though, and it becomes intriguing to HIT and IoT. Blockchain is “a distributed, secure transaction ledger that uses open-source technology to maintain data. Records are shared and distributed over many computers of entities that do not know each other; records can be time-stamped and signed using a private key to prevent tampering.” Each record block has an identifying hash that links each block into a virtual chain. (Wikipedia has a more complete description.) For bitcoin, it ensures security, anonymity and transferability without a central bank. For healthcare, distributed data and security is the exact opposite of the highly centralized, locked down approach of standard HIT to enable interoperability and security (left above). The Federal ONC-HIT (Office of the National Coordinator for Health Information Technology) under HHS is soliciting up to 15 proposals for “Blockchain and Its Emerging Role in Healthcare and Health-related Research.” through July 29. Cash prizes range from $1,500 to $5,000. The final eight will present at the awards presentation September 26-27. Potential uses are:

  • Medical banking between dis-intermediated parties
  • Distributed EHRs
  • Inventory management
  • Forming a research “commons” and a remunerative model for data sharing
  • Identity verification for insurance purposes
  • An open “bazaar” for services that accommodates transparency in pricing

Health Data Management, Information Management, Federal Register announcement

Why hackers feel the $$ love for healthcare: Brookings study

click to enlargeIt’s the information, silly! A recent study by the Center for Technology Innovation at the Brookings Institution tells us what we already know: healthcare organizations hold high-value information electronically, and because they haven’t invested equally in cybersecurity, it’s all vulnerable. When those nifty EHRs hold names, dates of birth, addresses, Social Security numbers and health histories, they are eminently salable. What’s new here is that the vulnerability increases due to factors not based on security, but on legal and data exchange requirements:

  • Data sharing and accessing
  • Length of storage to comply with regulations
  • The size of the records–the more information they hold, the more vulnerable

Lay on top of this ransomware.

The worst threat is not the hacker in a Bulgarian basement, but what is termed ‘state actors’ who want health information for a variety of reasons. They may be compiling a big database:”…a dossier of individuals that they could use for social engineering for future attacks”–such as sending phishing emails to government employees with specific, accurate information that when opened, infect their computers with malware for another purpose. Some solutions presented are using an outside cloud storage provider; using blockchain, which requires both public and private encryption keys; intrusion-detection systems (IDS) and security information and event management (SIEM) software. CSO, Brookings report (28 pages)

Paper beats the EHR rock, docs in British Columbia conclude

“Moving to an electronic system should enhance the care we provide, rather than jeopardize it.” “We do not want a catastrophic event to occur in order to have our concerns heard.” “We do not feel that it is ethical to put patients at risk using a system that makes it difficult to ‘do the right thing’ and much easier to make a significant error.”

Nine weeks into the launch of a C$174 million Cerner EHR in March, emergency room and intensive care unit doctors Nanaimo Regional General Hospital in British Columbia, Canada reverted to paper orders and instructions out of concern for patient safety. Internists and others wanted to do the same. They formed a 250-member Medical Staff Association, which had enough concerns to go on the record with a report that included the above. One example: the lack of confidence in the electronic ordering system module for diagnostic tests, drugs and patient instructions was enough for sixty-one Association members to vote unanimously on a  “no confidence” motion in the system and a return to paper orders. The report also detailed “a multitude of physician-reported major safety issues from every department that deals with acute patient care.”

The B.C. provincial health authority, which in Canada’s system can overrule doctors and parent companies (Island Health), won’t remove the offending module, but is concerned enough to order additional resources and ongoing refinements, based on physician concerns and recommendations from a recent internal investigation. Island Health’s board also asked the health authority to: address fatigue in clinical staff and medical professionals; adjust resources to alleviate workload burden; Improve trust in the electronic health record and associated clinical care processes; work collaboratively with clinicians and medical staff to evaluate improvements in the electronic health record for quality and safe patient care. Times Colonist (BC)

Telemedicine, telehealth and ‘Healthy India’

While we in the West and much of Asia/Pacific can parse the differences in wearables, tablets vs. smartphones and debate the accuracy of EHRs, far simpler issues dominate the application of health tech in places like India. Some are familiar–connectivity and preconceived notions of staff acceptance–and others are familiar to those of us who work in developing countries, such as interrupted power and a lack of trained people. Telemedicine and the reading of vital signs in telehealth has been part of the Indian scene for years–16 according to the article–but only in the past three years have remote consults been used more frequently. In the past year, over 100 patients have been saved by telehealth centers at two locations operated by Apollo TeleHealth in Himachal Pradesh, a province where the average patient travels up to 50 km for primary care and 250 km for secondary care. It is state-subsidized in a public-private partnership, but Apollo is already tracking over 15 months 3,000 teleconsults, providing emergency care to at least 200 people and saving Rs 15 lakh ($22,400 or £17,100).

The greatest impediment, according to the joint managing director of Apollo Hospitals Enterprise Limited (and the author), is the resistance to change–a familiar one. Telehealth services: A prescription of technology that saves lives, saves costs (Hindustan Times)

Aarogya Bharat, or Healthy India, is a ‘roadmap’ to enable India’s growth and prosperity by improving health for India’s population. Most Indians pay out of pocket, (more…)