Next DHACA Day 9th July, London – seeking new members (psst–it’s free)

May 16, 2019 | by

DHACA, the Digital Health and Care Alliance, with some 850 members currently, is having a new membership drive among SMEs working in the UK’s digital health & care space, following the kind offering of new sponsorship by Kent Surrey and Sussex AHSN and UCL Partners. 

The organisation’s objective is to help members develop their innovative products and services commercially, to achieve successful sales to the NHS. DHACA works right across the UK.

If you aren’t a member, you can sign up here to ensure you are kept aware of important news and of DHACA events. Membership is entirely free and members’ details will of course never be passed on to any other organisation.

Whether or not you are currently a member, booking is now open for the next DHACA Day. This event is primarily aimed at informing members working in the digital health & care sector of the major recent changes they need to be aware of, and how best to navigate them to make greater sales to the NHS and other health & care organisations. There is a small charge of £30+VAT to provide lunch, otherwise all other costs will kindly be covered by the event Sponsors, Baker Botts, in whose premises at 41 Lothbury (the opposite side of the Bank of England to the Bank Tube) it will be held.

The draft agenda includes talks by Luke Pratsides, Clinical Lead, Digital Development, NHS England about NHSX, Sam Shah, Director of Digital Development at NHS England and James Maguire, Clinical Advisor in Digital Innovation & AI at NHSX on NHS England’s digital development strategy, Mark Salmon, Programme Director, NICE on their HealthTech Connect and Evidence Standards, Neil Foster, Partner, Baker Botts on Finance for digital health start-ups, Neil Coulson, Partner, Baker Botts, on IP protection and the GDPR, Rob Berry, Commercial Director, UCL Partners on how the AHSNs can help SMEs and much more. Neil McGuire, Clinical Director of Devices, MHRA, has also been invited to update attendees on MDR implementation – a most important topic.

DHACA is keen to get members’ views on how they’d like it to be organised and governed in order to deliver what members want, so there will be time in the middle of the day for this too.

Should be a great day!

(Disclosure: this Editor is also DHACA CEO) 

 

News, events roundup: FDA clears AliveCor’s first 6 lead ECG, Jawbone Health rises from ashes, Let’s Get Checked’s $30M check, Health Wildcatters’ $35M ‘how to’ breakfast

May 14, 2019 | by

AliveCor receives FDA clearance for KardiaMobile 6L, the first FDA-cleared personal 6-lead device. From the AliveCor release, the description: “In addition to the two electrodes on the top of the device, there is one additional electrode on the bottom. The user places her thumbs on each of the two top electrodes, and places the bottom electrode on her left knee or ankle. This formation, known in cardiology as the Einthoven Triangle, allows cardiologists to view electrical activity in the heart from six perspectives or “leads.”” The information is sent to the mobile device’s software including KardiaAI bradycardia and tachycardia detection features cleared recently for the single-lead KardiaBand, as well as deeper information into arrhythmias. The single-lead ECG space that AliveCor pioneered with first their snap-on then the KardiaBand is now crowded with the Apple Watch, Withings, and numerous others. It’s a big step forward for the company. AliveCor has opened pre-orders now at $149, to be delivered starting in June. Hat tip to co-founder Dr. Dave Albert. 9to5Mac, Biospace (release), Mobihealthnews. 

Save Your Jawbones, the Founder Rises Again. Yes, Jawbone founder Hosain Rahman just raised $64.5 million for a new company. The new outfit, dubbed Jawbone Health, will offer a “personalized subscription service where we take all of this continuous health data about you and we combine that with a lot of machine intelligence . . .” to prevent avoidable diseases. After having burnt to a crisp $1 billion over 10 years on wireless speakers and fitness bands, again Mr. Rahman goes into territory which isn’t exactly unique with the footprints of the aforementioned Apple Watches, Withings, Spry Health’s Loop, EarlySense, etc. But hey,  SignalFire and Refactor Capital in the Bay Area, Polymath Ventures and Meraas in Dubai like his style. Even TechCrunch is arching an eyebrow.

Let’s Get Checked checks in with $30 million raise. This NYC-based direct-to-home supplier and manufacturer of in-home test kits raised a $30 million Series B from Leerink Transformation Partners, Qiming Venture Partners USA, and Optum Ventures after last year’s $10 million Series A. Customers can order in-state physician-approved laboratory tests via LetsGetChecked.com or through partner retailers, including CVS, Walmart, Pharmaca, and McKesson online stores, with delivery in 1-2 days. Tests covering wellness, men’s and women’s health are processed by CLIA-certified reference labs with results sent to a secure online account in 2-5 days, with the customer referred to in-state physicians for interpretation of results and further action if needed. PrivaPath Diagnostics markets in the US, Canada, Ireland, and Europe. Release

Speaking of raising money, how about $35 million for your med device startup? Health Wildcatters is hosting one of their Pulse Health Startup Education Series breakfasts (7.30-9am) in Dallas on Tuesday 21 May with main speaker Ken Nelson from Bardy Diagnostics, which just had a $35.5 million Series B, presumably letting everyone in on the secret. Registration and more information here.

CVS-Aetna hearing starts June 4; now only 6 witnesses called, for and against (updated)

May 13, 2019 | by

The next chapter of the ‘Perils of Pauline’ saga that is the CVS-Aetna merger won’t commence until June, as it turns out, but already the amici curiae are piling up on both sides. Judge Richard Leon of the US District Court for the District of Columbia has been lining up the witnesses he’ll be hearing from, both for and against. 

On the ‘anti’ side, testifying that the settlement agreement would be anti-competitive and not in the best interest of consumers, the American Medical Association (AMA) had called in three professors, the AIDS Healthcare Foundation three, and Consumer Action and the US Public Interest Research Group (PIRG) one. On the ‘pro’ side, put forward by CVS and for the Department of Justice, are five witnesses, healthcare executives and government consultants, who will testify that actions taken by CVS and DOJ will preserve competition and benefit consumers.

Certainly as we clock the ninth month after DOJ approved the merger and the companies have closed the deal, the drama continues, as Judge Leon continues to get coverage and the merger continues to be held up in this highly unusual proceeding. HealthLeaders 22 April and 7 May.

Update 13 May. The DOJ is challenging the three AMA witnesses, saying that they will be broadening the hearing beyond the settlement agreement which is what the review by Judge Leon is supposed to be about. On the other hand, the judge has already stated that the settlement covers “about one-tenth of 1%” of the merger, so he is already staking out a much larger territory. The AMA, of course, is quite pleased with the opportunity. Is this hearing pushing the envelope of judicial overreach in this judge’s interpretation of what a District Court can do under the Tunney Act? We can only wait and see. Healthcare Dive 13 May. Our coverage of the hearing to date here.  

Update 14 May. DOJ of course lost its fight with Judge Leon to limit the scope of the hearing and the AMA witness testimony, with the judge stating it is “essential” to understand how PBM affects Medicare Part D drug plans, though Aetna divested itself of the latter at DOJ’s direction. Both sides have three approved witnesses each for the three-day hearing. The ‘antis’ are Neeraj Sood (AMA), Diana Moss (Consumer Action/PIRG) and Michael Wohlfeiler (AIDS Healthcare foundation). The ‘pros’ are Alan Lotvin (CVS Health), Terri Swanson (Aetna) and Lawrence Wu (NERA Consulting). Healthcare Dive 14 May

Harris Healthcare acquires in-hospital workflow tech pioneer Uniphy Health

May 10, 2019 | by

Harris Healthcare, a computer systems company in clinical information systems, is adding Uniphy Health to its portfolio. Uniphy is a Newark NJ early-stage company which specializes in workflow solutions and team communications. Uniphy, which this Editor has been following since it was Practice Unite in a tiny office located at NJIT in 2015, now serves 90,000 clinicians with desktop and mobile apps at hundreds of healthcare facilities. Harris and Uniphy have worked together at several locations including Hunterdon Healthcare.

Uniphy and its 24 person team will be staying in Newark and near NJIT as Uniphy Health Solutions under Harris’ clinical services unit.  CEO and co-founder Adam Turinas will move to VP of the Uniphy group. According to Mr. Turinas, Uniphy fills a gap in Harris’ offerings and can fit within their clinical solutions such as EHR, patient access, patient experience, and revenue cycle management technologies. Best wishes to the team, including co-founder Stuart Hochron, MD! Mobihealthnews, MedCityNews, Uniphy release

Events, dear friends, events in London from painting to leadership

May 10, 2019 | by

‘Framing the Future’, Paintings in Hospitals 60th Anniversary. Monday 13 May at 6pm, Royal College of Physicians

What is the past, present and future role of arts in health? Considering the past pioneers and future innovations of visual arts in health and social care is a panel including Edmund de Waal OBE (artist and author), Dr Errol Francis (CEO of Culture&), Dr Val Huet (CEO of the British Association of Art Therapists), Prof. Victoria Tischler (Professor of Arts and Health at the University of West London) and Ed Vaizey MP (Chair of the All-Party Parliamentary Group on Arts, Health and Wellbeing). This event is waitlisted, but was fascinating enough to warrant a mention.

HealthChat with Ruth May, Chief Nursing Officer for England, Thursday 23 May at 5.30pm, The King’s Fund

Organized by UK Health Gateway, this evening with Ms. May will delve into issues such as workforce, her priorities, and how she will unite nurses in planning for the future? Tickets through Eventbrite are £19.95 – £39.95.

HealthChat with Rashik Parmar MBE. Monday 10 June at 5.30pm, The King’s Fund

Organized by UK Health Gateway, this evening with Mr. Parmar who is a Fellow of IBM, the leader of IBM’s European technical community and an IBM Distinguished Engineer will be about technology, data mapping, and AI. Tickets through Eventbrite are  £19.95 – £39.95.

Hat tip to Roy Lilley and his NHSManagers.net newsletter for the above three events

Ninth annual leadership and management summit. Wednesday 10 July starting 8am for the full day. The King’s Fund

The King’s Fund’s annual leadership event is for senior leaders in health and care organizations across the public, private and third sectors. Topics will be centered on leadership capabilities and cultures that enable teams to deliver better patient care and value for money, while also delivering continuous improvements to population health. Speakers include the Rt Hon Matt Hancock MP and Simon Stevens, CEO of NHS England. More information and registration here.

 

Telepsychiatry improves time to care plus frequency of care for behavioral health patients: study

May 9, 2019 | by

A study published in the Journal of Rural Mental Health of the American Psychological Association (abstract) studied the usage of hybrid psychiatric care–a combination of telepsychiatry and in-person care–among rural dwelling patients. Their findings were quite positive:

  • Hybrid care reduced time to in-person care by 30 percent in the intervention group versus the control group of in-person care only
  • Two-thirds of those receiving hybrid care had an outpatient telepsychiatry encounter per month, as opposed to 50.3 percent among the control group
  • The intervention group used telepsychiatry for over a quarter of their visits

Emergency department visits, antipsychotic medication adherence and readmission rates were similar among both groups.

The retrospective analysis of 242 patients (outpatient visit + 11 months) studied adult Medicaid patients in Missouri who had received a telepsychiatry visit following a hospitalization or emergency department visit resulting from substance use disorder or a behavioral health episode. 

Rural America is considered to be highly underserved in mental health, with many barriers to follow-up care after an inpatient admission or an ER/ED visit. As the authors of the study stated, ‘the current study suggests that offering telepsychiatry can help close the gap in access to mental health care between rural and urban populations, particularly during the time after an inpatient admission or an emergency department visit. As telepsychiatry service options continue to grow, making this delivery mode available to rural populations may have a positive impact on mental health outcomes in the United States.’ The Mobihealthnews article attributed the telepsychiatry system to Genoa Healthcare.

It’s NICE to HealthTech Connect with the NHS

May 8, 2019 | by

The National Institute for Health and Care Excellence (NICE) launched last week a resource for a wide range of health care technologies to gain traction in the UK. NICE’s HealthTech Connect is a free portal for companies and developers that enables “companies to understand what information is needed by decision makers in the UK health and care system, and clarify possible routes to market access.” It centralizes information on companies who enter their information for consideration by organizations which are seeking technologies or offering support such as funding, market access, and evaluation.

For this ‘single point’ initiative, NICE has brought on an impressive roster of partners and funders in England, Scotland, and Wales including NHS England, NHS Supply Chain, the NIHR Innovation Observatory, the AHSN Network, Office for Life Sciences, MHRA, and NHS Clinical Commissioners. Over 100 companies registered on the site, with 13 technologies submitted, since a soft launch in January. Already one company, Sonata System/Gynesonics, has been selected for a Medtech Innovation Briefing. HealthTech Connect will also facilitating fast tracking within the Accelerated Access Collaborative. NICE release, Mobihealthnews

The Theranos Story, ch. 60: becoming a Cautionary Tale of Silicon Valley Ethics

May 8, 2019 | by

It’s just weird. It’s just a bit surreal. When you see someone have this situation and pretend that everything is normal. It’s so bizarre.–Erika Cheung, former Theranos lab associate, whistleblower

Will health tech learn its lesson? As in Chapter 58, we are now in Full Retrospective on Theranos, with Cautionary Tales abounding. One of the better ones is from one of the two young whistleblowers profiled in John Carreyrou’s ‘Bad Blood’, Erika Cheung. She was the young (23) lab associate who saw patient samples from Walgreens and other patients constantly fail quality controls, finally reported it to regulators when nobody listened, then quit. The interview in STAT is refreshing. Ms. Cheung’s contrast of what she saw on the lab bench and in her encounters with Ms. Holmes versus the wide-eyed hype of Elizabeth Holmes in Fortune and Forbes circa 2014 is worth the read, along with her restart at 28 in Hong Kong founding an accelerator, Betatron, and a non-profit with fellow Theranos whistleblower Tyler Shultz, Ethics in Entrepreneurship, to try to pin the Jello On The (Shady) Wall that embodies Silicon Valley Ethics. Also Mobihealthnews on Ms. Cheung’s appearance at The Atlantic’s Pulse event. (The Atlantic still has a pulse?–Ed.)

Cautionary Tales continue, with the recent examples of Nurx, an e-prescriber specializing in women’s health, storing returned birth control pills in a closet shoe organizer and illegally remailing them to new customers (NY Times) and uBiome, a company that sells tests that sequence the bacteria of the body’s microbiome, on fraudulent billing that triggered an FBI raid. Both companies raised significant funding of late: Nurx over $41 million and uBiome over $100 million. The Silicon Valley rules–fake it to make it, and move fast, break things–once again blowing back on what may be good companies. The temptation may be too great for these health tech startups, something reflected on in this CNBC article.

TechCrunch, which breathlessly hyped Theranos back in the day, while duly noting and linking to the programs on How Theranos Fell, puts on its hair shirt for Dear Hollywood, here are 5 female founders to showcase instead of Elizabeth Holmes. Interestingly, one is not Anne Wojcicki of 23andme. 

Events coming up soon–and in the autumn: Hunter College 13 May, Aging 2.0 London 21 May; NYeC’s November Gala, Connected Health Summit (16-18 Oct) poster call

May 7, 2019 | by

Health Tech and the FDA: What You Need To Know, Monday 13 May, from 5-7pm is a discussion on what you need to know if your health or medtech service or device needs FDA approval. The main presentation is by Rebecca Wood, Partner at Sidley Austin LLP and former Food and Drug Administration Chief Counsel, and moderated by Charles Platkin, PhD, JD, MPH, the co-executive director of the Hunter College Center for Health Technology. Tickets are free but registration is required here (Eventbrite). Location is Hunter College, 2180 Third Avenue @ 119th Street, Main Auditorium (on 2nd Floor), NYC. Hat tip to Sonia K. Gonzalez in the Health 2.0 NYC Community.

And in London 21 May, conveniently the evening before the Digital Health and Care Congress, warm up at Aging 2.0 London to learn how age-tech “Zebras” (Z) a/k/a businesses, can take advantage of age-tech advances and hear from a panel of five from start ups, investors and government on the opportunities, challenges and realities of the UK tech business. Hurry–the website indicates only 25 tickets left. London, 21 May, 5.30 pm at Google for Startups London Campus, 4-5 Bonhill Street London.

Save the date, and plan ahead! The New York eHealth Collaborative, a regional non-profit organization that promotes the integration of health information through exchanges (HIEs), hosts an annual Gala that is one of the major events on the local New York healthcare business calendar. This year, the Gala will be the evening of 20 November at the Edison Ballroom in Manhattan. Your Editor attended in 2017 (missed 2018) and it was a memorable event. It annually honors three to four national healthcare executives who are also leaders in healthcare technology. If you are at all engaged with healthcare systems and technology in the New York metro area, it’s worth your time and fisc to attend this event to be the company of over 250 C-suite executives, leaders, and policymakers. Gala and Awards website  

Your Editor still misses their conferences, the last of which was one of the best she ever attended in (unbelievably) 2016 [TTA 17 Jan 17]. In 2014, their conference was also the site of an epic Eric Topol/Ezekiel Emanuel ‘face-off’ of radically diverging visions. That was hard to top! Their Executive Director Valerie Gray shares NYeC updates on YouTube including updates on Federal health tech initatives: TEFCA enabling nationwide health information exchange, and two similar proposed rules from CMS and ONC on interoperability, both with comment periods ending in June. 

Call for Poster Abstracts starts 27 May for the Connected Health Conference in Boston 16-18 October. Now a joint presentation of PCHAlliance and Partners HealthCare, the Call for Abstracts for Posters starts on 27 May and ends 27 June. The 2019 theme is Designing for Healthy Habits and Better Outcomes. For more information and application, see here. Winners receive a complimentary registration to the conference for the presenting author and discounted tickets for co-authors. TTA has been a past media sponsor of both the Connected Health Conference and NYeC’s Digital Health Conference.

International news roundup: Verily ‘eyes’ India, Oxford VR trials in Hong Kong, Israel-Finland collaborate, Blue Cedar-Blackberry partner, NuvoAir inhales $3M

May 2, 2019 | by

Verily rolls along in India with eye health research. Spending its fresh $1bn in funding [TTA 17 Jan], Verily and Alphabet sibling Google are researching machine learning in screening for diabetic retinopathy and diabetic macular edema. The retinal diagnostic program is at Aravind Eye Hospital, a network of eye hospitals headquartered in Tamil Nadu. Early research at Madurai has demonstrated that the algorithm performs on par with general ophthalmologists and retinal specialists assessing the images for disease. The estimated shortage of eye doctors in India is estimated at over 100,000. The stated objective of the research is to detect retinal disease earlier and expand access to screening. Further testing is verifying safety and effectiveness. Verily has received the CE Mark for the algorithm. Verily blog

Oxford VR in pilot to manage mental health in Hong Kong. Oxford VR, AXA Hong Kong and The Chinese University of Hong Kong (CUHK) have partnered for an “immersive therapy” trial using VR. This will focus on managing common mental health issues, such as social avoidance, anxiety and depressive symptoms. The scenarios will be in both English and Cantonese. Details will be announced in June. Mobihealthnews, Oxford VR press release

Israel and Finland are launching a joint collaboration announced last December, led by the Israel Innovation Authority (IIA) and the Helsinki Business Hub. The pilot program is starting with a Call for Proposals for joint projects. The two countries will co-develop, test, improve and pilot technologies, products and services in digital health, smart mobility and information and communication technologies. According to Mobihealthnews, the countries both have strong commonalities in public health systems with coordinated data sets, digital health, genomic projects, and advanced interoperability. Also The Jewish Voice

App security innovator Blue Cedar partners with Blackberry. Blue Cedar’s securing data from the app to the provider location will work with BlackBerry Dynamics-enabled mobile apps so that development teams will not be required to manually change source code or add libraries. Both Blue Cedar and Blackberry target international high-security fields such as healthcare, government, and financial. Blue Cedar blog

Swedish respiratory device/app NuvoAir inhales $3M in new funding. NuvoAir targets those managing asthma, COPD, and cystic fibrosis who need to monitor their breathing and lung health in conjunction with their overall health. Last year, the company developed the Air Next system, a portable device that connects via Bluetooth LE to users’ smartphones or tablets. Air Next has a CE Mark. NuvoAir plans to expand into Europe, North America, and Asia. The digital respiratory therapy area is booming, with an estimated 210 million asthma and COPD patients with smartphones worldwide a strong factor. One sign: Propeller Health’s premium acquisition by ResMed.  Mobihealthnews

The King’s Fund Digital Health and Care Congress arrives soon on 22-23 May

May 1, 2019 | by

Less than two weeks and counting to The King’s Fund’s Digital Health and Care Congress on 22-23 May in London.

Keynote speakers include Tara Donnelly, Chief Digital Officer of NHS England (opening Wednesday) and The Rt Hon Matt Hancock MP, Secretary of State for Health and Social Care (closing keynote on Thursday). General session panels and breakout session speakers include social care professionals, private sector executives, NHS managers, academics, and public policy makers. There’s breakout sessions aplenty on diverse topics, including four (W2A, W3A, T2C, T3C) chaired by our own Editor Charles Lowe of DHACA.

If you are UK-based or do business there, and you haven’t signed up, we’ll make it easy. This link here or on the right sidebar will take you straight to the program site. When you’re there to register, don’t forget to use the code Telehealth_10 to get an exclusive 10 percent discount for our Readers. TTA is pleased to be again an official supporter of the Digital Health and Care Congress.#KFdigital19

Comings and goings: Cuts hit Athenahealth, IBM Watson’s Drug Discovery unit; Bain may sell Waystar RCM

April 25, 2019 | by

Athenahealth has announced they are trimming 4 percent of their total workforce. With a large 900-person campus in Belfast, Maine that once belonged to MBNA credit cards, and a workforce of about 5,000 headquartered in Watertown, Massachusetts, there is considerable local concern in an area of Maine that offers few well-paying jobs. Reportedly dozens of jobs there will be lost. This caps a tumultuous period with the company. Athenahealth was acquired last November by Veritas Capital and Evergreen Coast Capital, then merged with a GE Healthcare spinoff they owned, Virence Health, in value-based care, under the Athenahealth name. Bangor Daily News

IBM Watson’s Drug Discovery product, which was targeted to pharmaceutical companies, is being cut back to work with only current partners and with clinical trials due to poor sales. According to The Register, a tart-tongued UK tech website which actually reached an IBM spokesperson, IBM’s Ed Barbini stated that “We are not discontinuing our Watson for Drug Discovery offering, and we remain committed to its continued success for our clients currently using the technology.” Also Seeking Alpha. IBM Watson and Watson Health, like Athenahealth, are moving through a rocky period of closing initiatives (Watson Workplace), layoffs, executive departures (head Deborah DeSanzo last November), bad publicity, and clients like MD Anderson who don’t part quietly. [TTA 8 Nov 18].

Another merged health infotech company may have a new owner soon. Waystar, which was formed by the acquisition of ZirMed and Navicure in 2017 and manages revenue cycles for 450,000 practices, is rumored to be up for sale by owner Bain Capital. Interested parties include Visa and Oracle. Bloomberg

The Theranos Story, ch. 59: there’s life left in the corporate corpse–patents! And no trial date in sight.

April 25, 2019 | by

You can get blood out of this. Really! The US Patent and Trademark Office (USPTO) awarded five–count ’em, five!–patents to Theranos in March and April. All of them were filed between 2015 and 2016, when the whispers of fraud were getting louder, as were the legal threats.

The five patents are:

1. Systems, devices, and methods for bodily fluid sample collection, transport, and handling
2. Systems, devices, and methods for bodily fluid sample transport
3. Systems and methods for sample preparation using sonication
4. Systems and methods for sample preparation using sonication (cell disruption)
5. Rapid measurement of formed blood component sedimentation rate from small sample volumes

The CB Insights Research article has the details on what they cover, including patent application illustrations. It’s not stated, but looking back to TTA’s many articles, in this Editor’s judgment, the heir to these patents cannot be Elizabeth Holmes or her many investors now feeling the lint in their pockets, but the company holding the last note, the $65 million (not $100 million) loan from Fortress Investment Group LLC, part of Japan’s SoftBank Group [TTA 28 Dec 17]–collateralized by the portfolio of over 70 patents. Hat tip to HISTalk 19 April

If you hunger for a deep dive into the design of Theranos’ blood analyzers that never really worked, and can appreciate that the miniLab was what “one expert in laboratory medicine called “theater … not science”, this Design World article is for you: Schadenfreude for Theranos — and satisfaction in how engineering doesn’t lie

Meanwhile, back in the US District Court in San Jose, California, we learn that the trial of Ms. Holmes (now engaged to William “Billy” Evans, a 27-year-old heir to the Evans Hotel Group, which has three West Coast resort properties and who is also a techie) and former Theranos president Ramesh ‘Sunny’ Balwani has been delayed indefinitely. Originally reported to be summer entertainment with a start date of 8 July, the judge set the next status conference for the case for 1 July, but refused to set a trial date, which means that the trial may not begin till next year. According to the San Jose Mercury News, the defense is seeking materials from the FDA and CMS, which are, according to defense lawyer, lawyer Kevin Downey, are “in many instances exculpatory.”

Ms. Holmes’ lawyers are also seeking information on the communications between John Carreyrou of the Wall Street Journal, the FDA, and CMS. In a motion filed last week, they accused Mr. Carreyrou under the guise of investigative journalism of “exerting influence on the regulatory process in a way that appears to have warped the agencies’ focus on the company and possibly biased the agencies’ findings against it.” Stat

The bubbly Ms. Holmes and Not-So-Sunny Balwani are facing Federal charges of two counts of conspiracy to commit wire fraud and nine counts of wire fraud. They each face a maximum of 20 years in prison and up to $2.7 million in fines.

AI and machine learning ‘will transform clinical imaging practice over the next decade’

April 24, 2019 | by

The great challenges in radiology are accuracy of diagnosis and speed. Yet for radiology, machine learning and AI systems are still in early stages. Last August, a National Institutes of Health (NIH)-organized workshop with the Radiological Society of North America (RSNA), the American College of Radiology (ACR) and The Academy for Radiology and Biomedical Imaging Research (The Academy) kickstarted work towards AI. Their goal was to collaborate in machine learning/AI applications for diagnostic medical imaging, identify knowledge gaps, and to roadmap research needs for academic research laboratories, funding agencies, professional societies, and industry.

The report of this roadmap was published in the past few days in Radiology, the RSNA journal. Research priorities in the report included:

  • new image reconstruction methods that efficiently produce images suitable for human interpretation from source data
  • automated image labeling and annotation methods, including information extraction from the imaging report, electronic phenotyping, and prospective structured image reporting
  • new machine learning methods for clinical imaging data, such as tailored, pre-trained model architectures, and distributed machine learning methods
  • machine learning methods that can explain the advice they provide to human users (so-called explainable artificial intelligence)
  • validated methods for image de-identification and data sharing to facilitate wide availability of clinical imaging data sets.

Another aim is to reduce clinically important errors, estimated at 3 to 6 percent of image interpretations by radiologists. Diagnostic errors play a role in up to 10 percent of patient deaths, according to this report.

It is interesting that machine learning, more than AI, is mentioned in the RSNA materials, for instance in stating that “Machine learning algorithms will transform clinical imaging practice over the next decade. Yet, machine learning research is still in its early stages.” Radiology actually pioneered store-and-forward technology, to where radiology interpretation has been farmed out nationally and globally for many years. This countered a decline in US radiologists as a percentage of the physician workforce that started in the late 1990s and continues to today with some positive trends (Radiology 2015). Perhaps this distribution model postponed development of machine learning technologies. Also Healthcare Dive, RSNA press release  

Win the Trillium II prize and get €1,000!

April 18, 2019 | by

The Trillium II EU project has just extended the deadline for entries to the Trillium II prize to 15th May, so there’s still plenty of time to enter. The prize of €1000 will go to the organisation that comes up with the best proposal to publicise and deploy the International Patient Summary (IPS). This is an internationally-agreed standard for summarising a person’s health record – as it is adopted worldwide, wherever someone is in the world a clinician will be able instantly to see and understand the main aspects of that person’s health record. This will particularly result in improved patient outcomes, faster treatment, lower healthcare costs and reduced medical errors. It will be of particular interest to readers whose products or services access local health records, as it should mean that in future they no longer need tailoring to the specifics of those records.

Details are here – note that to enter you will need to contact Lene Taustrup at lta@medcom.dk

To date, not many entries have been completed, so the probability of winning with a new entry could be high.

(Disclosure: this editor is CEO of DHACA, the Digital Health & Care Alliance, which is a participant in this EC-funded project).

International news roundup: ATA dispatches, compete for funding in Helsinki, Spry FDA-cleared for COPD, Merck acquires ConnectMed Kenya

April 18, 2019 | by

There’s not much news so far from the just-wrapped ATA 2019 conference in New Orleans, but POLITICO Morning eHealth highlighted a drop-by by Sen. Bill Cassidy from Louisiana, urging attendees to demonstrate to their local politicos that telemedicine is safe and effective–and be ready to answer questions about fraud or misuse. Louisiana’s Ochsner Health System is branching into retail with the O Bar, cleverly designed to look like an Apple Store to merchandise wearables and other health tech devices. For Ochsner patients, they can enroll into RPM programs and have their data directly input into their Epic EHR. American Well released a survey of 800 doctors, with the unsurprising finding that 22 percent have used telehealth to treat patients, but this is up 340 percent since 2015; also that the doctors finding telehealth most attractive to practice are also reporting high levels of burnout. Looking for more substantiative news from NOLA.

It’s Helsinki for pitching your digital health idea in June. The 11th edition of the interestingly named EC2VC Investors Forum and Pitch Competition is now part of HIMSS/ Health 2.0 Europe 2019. Healthcare startups and SMEs looking for funding can apply, with 12 companies to be selected to present before a jury panel of digital health investors. The format is a four-minute pitch, followed by six minutes of Q&A. More information and to apply by 6 May, with finalists selected by 13 May. The event is 11 June from 13:00 to 16:00 at Messukeskus Helsinki Expo & Convention Centre. 

Spry Health’s Loop wearable device gained FDA clearance. Spry is a RPM device company with a wrist-wearable device that measures pulse oximetry, respiration, heart rate, and blood pressure (research only) through optical sensors. While users can receive reports on the display and alerts, it is primarily meant for clinical monitoring by physicians in healthcare systems. The RPM is meant to detect signs of patient deterioration and exacerbations early so that actions can be taken. For the present time, the company is focusing on the device’s use in COPD patients. Certainly there is a large market in the US–there are 12 million diagnosed patients, with COPD the third leading cause of death with over 120,000 deaths per year. Mobihealthnews, BusinessWire, MDDIOnline

Merck acquires Kenyan digital health startup ConnectMed. The pharma company is purchasing ConnectMed’s telehealth applications in Kenya serving about 8,000 consumers, as well as related management systems. Merck will use the platform in conjunction with its Curafa point of care clinical and pharmaceutical services. Started in September of last year, these are run by local independent pharmaceutical technologists, clinical officers and nurses for underserved populations in Kenya. ConnectMed will cease operations. During its lifetime, it developed three DTC digital health services in Kenya and South Africa. WT/Startup Africa