News roundup: Proteus may be no-teous, DOJ leads on Google-Fitbit, HHS’ mud fight, Leeds leading in health tech, malware miseries, comings and goings

Proteus stumbles hard, cuts back. The original ‘tattle-tale pill’ company, Proteus Digital Health, plans to lay off 292 people in the San Francisco Bay Area and to permanently close its three Redwood City and Hayward locations, starting 18 January, according to notices sent to California state and local offices, including the state employment development department. It is unclear where Proteus will be located after the closures.

This followed after Proteus failed to launch a twelfth funding round of $100 million. According to reports, they furloughed most of their employees for two weeks in November and are reorganizing. This is after a substantial number of investors have put in about $487M in funding through a Series H (Crunchbase), including a game-changing investment by Novartis dating back to 2010.  Proteus achieved unicorn status about three years ago, but its high-priced pill tracking technology with a pill sensor tracked by a skin-worn monitor reporting into a smartphone has a built-in limited market to expensive medication. Otsuka Pharmaceutical in 2017 partnered with Proteus for an FDA-cleared digital medicine system called Abilify MyCite that basically put an off-patent behavioral drug back into a more expensive tracking methodology. But Proteus remains a great idea on tracking compliance in search of a real market, and may not have much of a future. San Jose Mercury News, CNBC

But ingestible detectable pills are still being tested. On Monday, as Proteus’ bad news broke, eTectRx announced its FDA clearance of the ID-Cap System and its testing at Brigham and Women’s Hospital and Fenway Health, focusing on HIV medication when used for treatment and prevention. Release, HISTalk

Department of Justice taking the lead on scrutinizing Google’s Fitbit acquisition. The Federal Trade Commission also sought jurisdiction over the transaction. According to the New York Post, “both agencies are concerned that a Google-owned Fitbit would give the search giant an even bigger window into people’s private data, including sensitive health information, sources said. Under the Hart-Scott-Rodino Act, all large mergers must file proposals with both the DOJ and the FTC, but only one antitrust agency reviews the merger.”

Coal from stockings being thrown about at HHS. According to POLITICO and the New York Times, the disagreements between Seema Verma, the head of the Centers for Medicare and Medicaid Services (CMS), and the Cabinet-level Secretary of Health and Human Services (HHS), Alex Azar, have boiled over, enough to have to be settled by the President’s acting chief of staff, Mick Mulvaney. According to the Times, both President Trump and VP Mike Pence have told them to find a way to work together. Both are administration appointees, but President Trump has not been reluctant to cut a mis-performing or overly contrary appointee loose. The latest salvo from those obviously not on Ms. Verma’s side was the revelation that she requested compensation for jewelry stolen on a business trip, contrary to government policy of course. She was compensated for other items which is standard. (Isn’t that what homeowners’ insurance is for? And what sensible person actually travels with valuable jewelry?) Under Ms. Verma, CMS has been quite progressive in developing new business models in Medicare fee-for-service, moving providers to two-sided risk, and innovating in both Medicare and Medicaid. It will either be settled, or one or both will be gone. Pass the popcorn.

Leeds picks up another health tech company. Mindwave Ventures is opening an office there, as well as appointing Dr Victoria Betton and Dr Janak Gunatilleke to the roles of chief innovation officer and chief operating officer. Mindwave develops technologies around digital products and services in healthcare and health research. Leeds reportedly is home to over 250 health tech companies and holds an annual Leeds Digital Festival in the spring [TTA 11 April].

Ransomware attack hits Hackensack Meridian. Systems were down for about a week. While this large New Jersey health system hasn’t admitted it, sources told the Asbury Park Press that it was ransomware. And if it’s not ransomware, its Emotet and Trickbot. Read ZDNet and be very apprehensive for 2020, indeed, as apparently healthcare is just one big target.

Comings and Goings: There may be some end of year bombshells, but after last week’s big news about John Halamka, it’s been fairly quiet. Paul Walker, whom this Editor knew at New York eHealth Collaborative, has joined CommonWell Health Alliance as executive director. Mr. Walker was most recently Philips Interoperability Solutions’ vice president of strategy and business development. CommonWell’s goal is improving healthcare interoperability and its services are used by more than 15,000 care provider sites nationwide. Blog release, Healthcare Innovation ….Dr. Jacqueline Shreibati, the chief medical officer for AliveCor, is joining Google Health in the health research area. Mum’s the word when it comes to Fitbit (see above). CNBC ….Peter Knight has pleaded guilty to falsifying educational credentials to gain his position as chief information and digital office at Oxford University Hospitals NHS Foundation Trust. He held that position from August 2016 until September 2018. BBC News

WOT with Proteus found equal to or better than DOT in TB medication adherence trial

Implications for administration of tuberculosis and other rigorous therapies. A test conducted by a California university team with tuberculosis (TB) patients comparing Wirelessly Observed Therapy (WOT) administered through Proteus Digital Health’s combination ingestible pill and sensor-based smartphone tracking, versus standard Directly Observed Therapy (DOT), found that WOT was equivalent to DOT in accuracy–and superior to DOT in supporting confirmed daily adherence to TB medications. It was also overwhelmingly preferred by participants. 

TB is a disease where treatment requires strict adherence to medication protocols over a lengthy treatment course and usually requires a period of direct observation of patient dosage. In the first part of the test examining accuracy under direct observation, the researchers reported a 99.3 percent rate of positive detection accuracy (95% CI, 98.1% to 100%) among 77 TB patients under treatment with IS-Rifamate. The second part of the study among 66 patients took place in a randomized control test. The Proteus WOT system was found superior to DOT in supporting confirmed daily adherence to TB medications during the continuation phase of TB treatment by 93 percent to 63 percent. The treatment course was as long as 29 weeks. Participants rated preference for a WOT system at 100 percent.

The study was performed by researchers from the University of California, San Diego, Stanford University, HHS and Orange County Health Care Agency and published in PLOS Medicine on 4 October. The team recommended that a WOT system like Proteus be used within high-burden TB settings in low and middle-income countries, especially as it can be monitored seven days a week versus a standard five days.  Mobihealthnews

About time: digital health grows a set of ethical guidelines

Is there a sense of embarrassment in the background? Fortune reports that the Stanford University Libraries are taking the lead in organizing an academic/industry group to establish ethical guidelines to govern digital health. These grew out of two meetings in July and November last year with the participation of over 30 representatives from health care, pharmaceutical, and nonprofit organizations. Proteus Digital Health, the developer of a formerly creepy sensor pill system, is prominently mentioned, but attending were representatives of Aetna CVS, Otsuka Pharmaceuticals (which works with Proteus), Kaiser Permanente, Intermountain Health, Tencent, and HSBC Holdings.

Here are the 10 Guiding Principles, which concentrate on data governance and sharing, as well as the use of the products themselves. They are expanded upon in this summary PDF:

  1. The products of digital health companies should always work in patients’ interests.
  2. Sharing digital health information should always be to improve a patient’s outcomes and those of others.
  3. “Do no harm” should apply to the use and sharing of all digital health information.
  4. Patients should never be forced to use digital health products against their wishes.
  5. Patients should be able to decide whether their information is shared, and to know how a digital health company uses information to generate revenues.
  6. Digital health information should be accurate.
  7. Digital health information should be protected with strong security tools.
  8. Security violations should be reported promptly along with what is being done to fix them.
  9. Digital health products should allow patients to be more connected to their care givers.
  10. Patients should be actively engaged in the community that is shaping digital health products.

We’ve already observed that best practices in design are putting some of these principals into action. Your Editors have long advocated, to the point of tiresomeness, that data security is not notional from the smallest device to the largest health system. Our photo at left may be vintage, but if anything the threat has both grown and expanded. 2018’s ten largest breaches affected almost 7 million US patients and disrupted their organizations’ operations. Social media is also vulnerable. Parts of the US government–Congress and the FTC through a complaint filing–are also coming down hard on Facebook for sharing personal health information with advertisers. This is PHI belonging to members of closed Facebook groups meant to support those with health and mental health conditions. (HIPAA Journal).

But here is where Stanford and the conference participants get all mushy. From their press release:

“We want this first set of ten statements to spur conversations in board rooms, classrooms and community centers around the country and ultimately be refined and adopted widely.” –Michael A. Keller, Stanford’s university librarian and vice provost for teaching and learning

So everyone gets to feel good and take home a trophy? Nowhere are there next steps, corporate statements of adoption, and so on.

Let’s keep in mind that Stanford University was the nexus of the Fraud That Was Theranos, which is discreetly not mentioned. If not a shadow hovering in the background, it should be. Perhaps there is some mea culpa, mea maxima culpa here, but this Editor will wait for more concrete signs of Action.

Rounding up July: Teladoc’s new name and earnings, Hitching a Lyft, GlobalMed with FCC, Proteus and HIV sensing, Parks Associates, Welbeing

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2017/12/Lasso.jpg” thumb_width=”125″ /] [grow_thumb image=”http://telecareaware.com/wp-content/uploads/2018/08/teladochealth_logo_plumaqua_rgb.jpg” thumb_width=”150″ /]Telemedicine giant Teladoc today formally unveiled its name and logo change to Teladoc Health. Citing its worldwide reach and a broad portfolio of services, CEO Jason Gorevic stated “…we will further accelerate the adoption of virtual care and enhance our technology-enabled services to make high-quality healthcare a reality for more people and organizations around the world.” The name will officially change on 10 August but there is no change in their NYSE ticker symbol TDOC. Release on MarketWatch  Their earnings call on Wednesday reported a second quarter loss of $0.37 per share which was substantially less than the projected $0.43. Revenue was $94.56 million for the quarter ended June 2018, more than double that of CY 2017. Zacks.com

The burgeoning area of non-emergency medical transportation (NEMT) got a Lyft with the publishing of two studies indicating reductions in costs and no-shows. Lyft rideshare partner Hitch Health which integrates EHR data, to identify patients, worked over 12 months with the Hennepin Healthcare internal medicine clinic in Minneapolis. The no-show rate dropped from 31 percent to 22.5 percent, with an estimated increase in revenue of $270,000. In Camden, NJ, Rideshare worked with a branch of the MD Anderson Cancer Clinic to schedule on-demand transportation, reducing direct transportation costs by 30 percent with the service and no-show rate down to four percent. Mobihealthnews

GlobalMed, a previous Perspectives contributor, was represented by its CEO on a four-person panel discussing the FCC ‘s proposed Connected Care Pilot Program, a new $100 million program to support telehealth for low-income Americans, attended by  FCC Commissioner Brendan Carr. Here’s a video from the 24 July meeting. Hat tip to Marcia Rhodes of Amendola Communications

Proteus Digital Health’s sensor-equipped pills, transmitter patch, and app may have a new market with prophylaxis (PrEP) treatments for the prevention of HIV transmission. A study by University of California, San Diego researchers with Truvada (Gilead Sciences) found that the sensor-equipped drug was well-received by most users and pharmacokinetically equivalent to Truvada alone. Proteus is the first FDA-approved digital ingestion tracking system with Abilify MyCite [TTA 14 Nov 17]. Mobihealthnews

Parks Associates has two upcoming opportunities for speakers at their hosted events at two large conferences. Click on the links for more information:

CONNECTIONS Europe: Strategies for Smart Home & Consumer IoT – Deadline: 1 Sept
Amsterdam – 13-14 Nov 2018  Event website

CONNECTIONS Summit at CES – Deadline: 15 Sept 2018
Las Vegas – 8 Jan 2019  Call for papers and more information.  

Welbeing in the UK announced on Wednesday 1 Aug their Rehabilitation Project in Cumbria. The program is designed to help patients who have had a fall or similar trauma leading to a hospital stay. When they are discharged, patients can now receive Welbeing’s alarm service for up to 13 weeks, free of charge. The service is being funded by Eden District Council. Welbeing recently acquired Eden Housing Association’s alarm and response services in Eden and Carlisle. (Link to press release to come)

Breaking: FDA approves the first drug with a digital ingestion tracking system

Not many drug approvals warrant an FDA press release, but this one did and deservedly so. The US Food and Drug Administration (FDA) approved a version of the psychiatric drug Abilify (aripiprazole) equipped with the Proteus Digital Health ingestible tracking system. Abilify MyCite has been approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. It is the first approved commercial version of a drug equipped with the Proteus Discover system, which tracks the ingestion of the pill from a sensor in the tablet activated by gastric juices to a patch worn by the patient and then to a smartphone app. The patient, caregivers, and physicians can track medication usage (timing and compliance) through the app, adjusting dosage and timing as needed.

The Proteus press release states that the rollout is gradual through select health plans and providers, targeting a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder. It is contra-indicated for pediatric patients and adults with dementia-related psychosis.

Abilify, developed by Japan’s Otsuka and originally marketed in the US with Bristol-Myers Squibb (BMS), has been generic since 2015. This Editor finds it interesting that Proteus would be combined with a now off-patent drug, creating a new one in limited release. Proteus’ original and ongoing tests were centered on combining their system with high-value (=expensive) drugs with high sensitivity as to dosage times and compliance–for instance, cardiovascular and infectious disease (hepatitis C, TB). Here we have a focus on managing serious mental illness and treatment. 

Editors (Steve and Donna) first noticed Proteus as far back as September 2009. Looking back at our early articles, Proteus has come a long way from ‘creepy’ and ‘tattletale’. With nearly half a billion dollars invested and a dozen funding rounds since 2001 (Crunchbase), approvals were long in coming–nine years from submission of patch and tablet sensor to the FDA (2008), seven years from the patch approval (2010), five years from the tablet sensor approval (2012), to release of a drug using the Proteus system. The only thing this Editor still wonders about is what happens to the sensors in the digestive tract. They contain copper, magnesium, and silicon–copper especially can be toxic. If the sensors do not dissolve completely, can this be hazardous for those with Crohn’s, colitis, or diverticulitis/diverticulosis?  Hat tip to Bertalan Meskó, MD, PhD, via Rob Dhoble, on LinkedIn.

Also, if you can stand it, a lengthy article from the New York Times with lots of back and forth about the existential threats of monitoring drugs, potential coercion (preferable to injected Abilify), how some with schizophrenia already manage, and Proteus as a ‘biomedical Big Brother’. (Some commenters appear to have the very vapors about any digital trackers, including AiCure and etectRx.)

6 helpful hints for healthcare startup founders–and funders

Investor Skip Fleshman of Palo Alto (of course)-based Asset Management Ventures has six points of sound advice for founders and developers–and funders of same–who think that their Big Idea(s) are the one thing which will revolutionize healthcare, particularly because of their personal experiences. We’ve observed that successful startups have fitted themselves into the Healthcare Establishment’s game [TTA 19 May], but if an investor is still seeing that attitude, it’s still there. AMV’s track record is there with investments in several healthcare companies, including Proteus Digital Health and HealthTap. Mr Fleshman’s points with this Editor’s comments:

1. Listen to the market–and it’s not direct-to-consumer, despite a cursory reading of Eric Topol. Find where your product or service can reduce or avoid cost, increase engagement and improve quality i.e. patient outcomes (which are all linked, see #4)
2. Hire people who know how to speak the language–experienced healthcare people who can work the system but also get the changes and want to make a difference. And no, they may not look or act like you. They’ll often have gray hair and families. Unless they are independently wealthy, they also expect to be paid decently. Quite a few will be women who don’t act or look like you either, but are invaluable in your organization in multiple ways.
3. Understand how the money flows–and the money is with providers, payers, self-insured employers and (Mr Fleshman doesn’t mention this) government (Medicare, Medicaid, the alphabet soup of HHS, CMS…). The incentives (shared savings) are now to providers to pull cost out of their system but somehow maintain population health quality and outcomes. How to pull this off is where the innovation is needed. Partner wherever you can–and this Editor would add, with other successful early-stage companies as well.
4. Read the Affordable Care Act–with a bottle of painkillers and eyedrops. (more…)

Caregiving a la robot: GeriJoy, Giraff Plus, CosmoBot

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/02/robot-cosmobot-85532261-slide-2.jpg” thumb_width=”150″ /]HP, a tech name not often associated with health monitoring, focuses on health tech in its Winter 2015 issue of HP Matter (produced by Fast Company). Focusing on monitoring and assistance for older adults, the Robot Caregivers article profiles the US’ GeriJoy, a ‘virtual pet’ on a tablet which acts as a therapeutic companion and, through the tablet camera, provides 24/7 video monitoring; Sweden’s Giraff Plus which combines home digital sensors with a tall mobile robot to comprehensively monitor personal well-being; and its pint-size cousin, CosmoBot (US), a character robot for education and therapeutics targeted to younger children. The wearables article notes AdhereTech‘s very smart IoT pill bottle and Proteus Digital Health’s smartpill to body sensor to smartphone monitor. There’s more about bionic prosthetic knees and making healthcare unhackable (!) promoting HP’s security software.

Short Tuesday takes

Alere, Optum, Wyss, Proteus, Soreon Research, Baywater Healthcare

Alere Health to be acquired by Optum. Alere is selling its condition, wellness and case management group for $600 million to the health services subsidiary of UnitedHealth Group. The surprise is that Alere Health, which presently serves 22 million patients in 29 states, includes two service lines considered hot: analytics and connected health. Alere Connect, the former MedApps, is included in this sale. Alere (the parent company) will be concentrating on rapid diagnostics. Alere Health release, fact sheet….Vibrating insoles may help to guide the balance-impaired, eventually. Research on stochastic resonance as an aid to balance and gait has been researched for nearly ten years–our earliest article on it was written by former EIC Steve in 2006. The current study tested ‘white noise’ to help lower the level of buzzing needed to generate stimulus in the feet. Conducted by the Institute for Aging Research (IFAR) at Hebrew SeniorLife, Beth Israel Deaconess Medical Center, the Wyss Institute for Biologically Inspired Engineering at Harvard University, Harvard Medical School, and Merck Sharpe and Dohme (MSD) Consumer Care. (more…)

Funding, granting and executive moves

Summer hasn’t been beach holiday time for some of the companies we’ve been following….Genetic testing for the masses 23andMe, only last fall in much hot water with FDA (but recently making nice–TTA 2 July), received a two-year, $1.4 million grant from the National Institutes for Health (NIH). iHealthBeat….’Smart pill’ developer Proteus Digital Health received a Series G round of $52 million, adding to a June round of $120 million. Investors not disclosed, but Proteus currently has a blue-chip list including Novartis, Medtronic and Kaiser. BusinessWire….Pre/post-procedure education and recovery monitoring service VOX Telehealth received another $1.1 million round of angel financing primarily from original investors, preliminary to an institutional round of financing in 1st Quarter 2015. Release….HealthSpot Station is reinforcing its retail reach (more…)