More evidence of confusion among clinicians over medical apps (UK) + MAUDE

A paper just published in the Annals of Medicine & Surgery entitled A UK perspective on smartphone use amongst doctors within the surgical profession also sheds some interesting light on the use of mobile apps by surgeons.

Given the recent advice to members by the RCP against the use of apps that are medical devices though not CE certified, the following finding is of especial interest, as it is widely considered that many clinical calculators meet the EU legal definition of a medical device:

…when looking specifically at senior doctors, the most common type of app utilised was clinical calculators followed by reference guides/handbooks and then drug reference guides.

The paper also confirms findings by this editor and others that clinicians are confused by the wide range of apps available and lack guidance on the effectiveness & efficacy of individual apps.

The majority of participants did not have any relevant suggestions for app development, which may suggest that there is an uncertainty over the catalogue available. Given concerns voiced in both our study and the work of others questioning the reliability of available resources, a possible solution would be the creation of a UK based app directory to outline availability with verification of performance and validity. However given the complexity of this regulation, peer review specific to the UK may have to suffice.

A short & interesting read that very much supports the need for a reference source for clinician-facing apps, and an objective measure of the benefits they deliver: recommended.

Whilst writing, Prof Mike Short has also drawn my attention to a related, very short, article entitled To Be or not to Be a Medical Device: Is the Regulatory Framework a Safety Rope or a Fetter? which thankfully concludes that:

Certainly, adhering to the standards listed <in the article> massively increase administrative overhead in research and development, extend the “time to market” and causes increased costs. However, this is the price to pay for success to reach the goal: Impact on patient care. Therefore, the answer to the question in the title of this article is: Software can be a medical device and from this point of view, we have to accept administrative overheads – and the regulatory framework can be a useful guide-line.

Perhaps more interestingly though it includes reference to the FDA’s ‘Manufacturer and User Facility Device Experience (MAUDE) which records product problems (obviously in the US), including those for medical software. Wouldn’t it be great if the EU had such a database for medical apps?

The dilemma of design for older people

Is the best design for older people and the disabled not specifically designed for them, but an adaptation of basic good design? Laurie Orlov in one of her apt Aging In Place Technology Watch articles questions the market viability of all those specially designed products we’ve seen since, say 2008. We recall ‘smart homes’, senior desktop computers, simplified phones and the robot caregivers which never seem to get past the prototype stage [TTA 25 July 14]. Her POV is that in most cases ‘designing for all ages is feasible today’ except for healthcare–durable medical equipment (DME) and healthcare delivery (and,this Editor would add, monitoring). One of her commenters points out that not everything can be designed ‘universally’, linking to this excellent article from Smashing on guidelines for designing tech to be used by those over 50. The section on blue color perception was especially interesting, as blue is healthcare’s #1 color. I would also point out that design which avoids stigma (as in ‘it screams OLD’) and has good aesthetics also wins.

Is AARP admitting that ‘tech designed for seniors’ is not a winning notion, as this May’s Life@50+ National Event in Miami is likely the last national event they sponsor? And it would be interesting to go back to the previous ‘Live Pitches’ to see how they are doing. Ms Orlov profiles this year’s five.

Call for presentation proposals: mHealth Summit (US)

click to enlargeYou have till 8 June to submit a proposal for a presentation at one of the largest digital health conferences in the US, the mHealth Summit (which is same place–near Washington D.C.–but a month earlier than usual–8-11 November). This year’s theme is “Anytime, Anywhere: Engaging Providers and Patients” and centered around one of five topics: clinical care, technology, patients and consumers, research, policy or business. The co-located Global mHealth Forum has a separate submittal process. Information and submittal linkTelehealth & Telecare Aware has been a media partner of the mHealth Summit US since 2010 and the 2015 Global mHealth App Developer Economics Study presented earlier this month at mHealth Summit Europe in Riga.

Telemedicine in diabetes management

Findings of a new literature analysis of the impact of telemedicine on diabetes management has been published in Telemedicine and e-Health.

The authors, from the University of Michigan and the University of Kentucky,  analysed 73 research publications (selected from a potential 17,000 list) published between 2005 and 2013. They conclude that although the individual research studies varied significantly in, for example, the outcomes measured, there was sufficient evidence to point to the positive effect of telemedicine.

The full paper describes the analysis methodology and gives detailed results and would be of interest to those working in diabetes management as well as those applying telemedicine to other long term conditions.

‘Internet Plus’ nurturing China’s nascent digital health market

Back in April this Editor was surprised by the interest Chinese investment companies had in Scanadu–and vice versa. Two of the three, Tencent Holdings and Fosun International, led the $35 million Series B round. Scanadu in return reportedly is developing products primarily for the China market, such as a urine analyzer.

Somewhat surprising, but it should not be, is the extent that private money tacks to the winds of official Chinese government policy. Ecns.com, the online site of the state China News Service, reports that part of the government ‘Internet Plus’ initiative will be targeted to the health and social care needs of 212 million people over 60 in China–a surprising 15.5 percent of the population. The civil affairs vice-minister has publicly advocated the use of the Internet, cloud computing and big data to transform care for the aged. Oddly, this also includes the development of ‘e-commerce’ for seniors.The language is also interesting and very careful–“The country’s population also features a large number of elderly people who are disabled and who are faced with empty nests and poverty” and a similar to the West shortage of carers. (more…)

Aetna may ‘buy into’ more analytics, digital health

Rumors now mainstreamed into press surround Aetna’s apparent interest in fellow insurers Humana and Cigna. Forbes last Friday started the ball rolling with an article last Friday focusing on the main event driving insurance payer consolidation: the transition of Medicare from fee-for-service to value-based bundled payments and accountable care organization (ACO) models. Humana has substantial Medicare business and a foot in home care (SeniorBridge), but has innovated in digital health: partnerships (Healthsense, TTA 20 Dec 13), purchases (what remained of Healthrageous, TTA 16 Oct 13), employee wellness (Vitality) and app development. Cigna is a major insurer with corporate business, but has struggled a bit in the digital health arena with the flashy-but-flopped patient engagement platform GoYou. It’s piloted telehealth to reduce readmissions with Care Innovations [TTA 7 Oct 14]  and Coach by Cigna, a mobile health platform in conjunction with Samsung for the Galaxy S5 and S6 phones.

Aetna has had some success with working with ACOs, with 62 contracts covering about 1 million lives, but this Editor counts over 400 practice-based ACOs in the Medicare Shared Savings incentive program alone. Their experiment in consumer app aggregation, CarePass, came to a quiet end last August and Healthagen, their ’emerging businesses’ unit, has had some swerves in rationale including iTriage and even ActiveHealth Management, their long-time population health analytics arm. While digital health is part of it (see Mobihealthnews), (more…)

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…)

After a long absence, a What the Blue Blazes award…or is that two?

blue-blazesThough recently threatened, the Telehealth & Telecare Aware What the Blue Blazes award has not been presented for some while, so it was kind of PC Magazine to draw our attention to an AT&T Innovation Day special of a Connected Car Seat that texts the car’s owners if it detects a child has been left in the car when the car temperature exceeds a pre-set level. When this editor’s two daughters were babies, leaving a dog in a car on a hot day was considered unacceptable, let alone a child, so to introduce a facility that may notify car owners of children at risk of overheating would seem to be the ultimate in irresponsible encouragement (most text messaging services of course guarantee neither delivery, nor maximum elapsed time to delivery, even if a parent happens to have their phone handy, & it’s switched on, & not on silent).

Now if the car was to persist in blowing its horn if it detected a car owner trying to leave a baby alone still strapped in the car on a warm day, or automatically phoned the police to report an overheating child left alone in a car, that might make more sense. (In Europe, the latter option – calling the police – couldn’t be simpler, as an add-on to eCall, the new automatic car emergency service being introduced across Member States in the next two years.)

Meanwhile in Jordan, a woman recovering from a caesarian section operation on April 24th, troubled by persistent vibrations in her womb (more…)

Indian Health adopting telemedicine in Southern California for diabetes treatment

Tribal-owned Riverside-San Bernardino County Indian Health, which serves nine tribes through seven health centers in the ‘Inland Empire’ of California, is adopting telemedicine to reach Native American patients and reduce their rate of diabetes. According to an Indian Health spokesperson, Native Americans constitute the largest diabetic population in the world and are 177 percent more likely to die from the disease. In San Bernardino County alone, 13 percent of adults are diabetic, and nearly 80 percent are overweight or obese. The initial program brought endocrinologists serving other Western tribes in on video consults with doctors in Indian Health clinics. Later rollout of the program will include pulmonology, cardiology, gerontology and dermatology. The market potential for telehealth remote patient monitoring–better information and analytics for clinicians, self-monitoring training and education for patients–could be substantial here for companies willing to invest time, learning and to build relationships. California Healthline. FierceHealth IT

UK, Nordics lead best EU countries for mHealth business: survey

Respondents to research2guidance’s fifth annual mHealth Economics survey rated UK and the Nordic countries the best for mHealth market success, based on factors of market readiness and maturity including doctors and consumers. Other top countries were Sweden, the Netherlands, Denmark and Finland. Germany and France were significant because of market size and investment in healthcare. According to the survey where over 5,000 healthcare app publishers and health professionals ranked countries on multiple points, “In UK, Sweden, Denmark and Netherlands doctor’s acceptance of apps and high level of digitalization are seen as main drivers. Germany is attractive mainly because of its substantial market size and its big number of potential users.”click to enlarge

Findings were presented this week at the mHealth Summit in Riga, Latvia and is the first part of a larger study on developer economics and future healthcare delivery. As a media partner, TTA participated starting in March in inviting respondents to the survey. A free download of the report is available to our readers here (minimal registration required). Release

Really big data analytics enlisted to fight soldier suicide (US)

Suicides by US active duty soldiers have more than doubled since 2001, according to a January Pentagon report, and current prevention programs have not been that effective in reducing the over 200 reported suicides per year. Enter a huge database program called STARRS–Army Study to Assess Risk and Resilience in Service–to identify risk factors for soldiers’ mental health. The US Army not only likes acronyms, but also never does anything small–a five-year, $65 million program analyzing 1.1 billion data records from 1.6 million soldiers drawn from 39 Army and Defense Department databases. Researchers are looking at tens of thousands of neuro-cognitive assessments, 43,000 blood samples, more than 100,000 surveys, hospital records, criminal records, previous risk studies, family and job histories plus combat logs. The study, also using resources from the National Institute of Mental Health, the University of Michigan and other educational institutions, will conclude this June–and researchers are now wrestling with the privacy and moral consequences of responsibly using this data for health and in leadership. NextGov

Nano nano nano: DNA sequencers in toothbrush, phone analyze, match genetic markers

Oxford Nanopore in the UK has developed microchip sequencers that read and encode DNA by passing it through a gap in the microchip some 1.5 nanometres across – 80,000 times thinner than a human hair. A small current is passed through the DNA which encodes the genetic material into a digital record, which can be compared against disease markers– for instance, Alzheimer’s and cancer. Microchips in this size can be embedded in future in toothbrushes and smartphones. Oxford Nanopore’s current palm-sized detector is currently being used to track Ebola in West Africa. Daily Express.

Drawing a parallel between healthcare and … newspapers

…is the point that Dave Chase, who founded patient information/engagement portal Avado and sold it to WebMD in 2013 (and with them until last month), is making in this Forbes article. As newspapers found their readership leaving in droves for online websites that delivered ‘news they could use’ faster and more interestingly, healthcare systems are finding that their patients are finding healthcare services outside their bricks-and-mortar:

  • Onsite workplace clinics (including telehealth/telemedicine hybrids such as HealthSpot Station–Ed. Donna)
  • Direct primary care providers such as Iora Health, Qliance, DaVita’s Paladina Health
  • Retail clinics: MinuteClinic, TakeCare Health
  • Medicare Advantage-only programs such as CareMore [TTA 5 May] and Healthcare Partners
  • Domestic medical tourism by large, self-insured companies for elective surgeries

This Editor would argue that these forces are at work even in (and perhaps because of) centralized payment systems, and are worldwide, not just in the US. Certain communities such as Rochester, NY, Dubuque IA and Seattle are focusing on lower healthcare as attractions to business–and countries such as Costa Rica, Mexico, Brazil, Singapore, Hungary and India are capitalizing on US-quality facilities and doctors to gain medical tourism for elective and self-paid surgery.

ATA’s hottest trend: advancing to Healthcare 2.0 via personalized healthcare

Guest columnist Dr Vikrum (Sunny) Malhotra attended ATA 2015 earlier this month. This is the third of three articles on his observations on trends and companies to watch.

For those who attended the American Telemedicine Association‘s meeting in Los Angeles, the overarching trend was how a personal healthcare system is taking shape. The three pillars include: care anywhere, care networking and care customization.

The ATA stage opened with a keynote speech by Dr Sanjay Gupta about celebrating new innovation and technology advancements. This is the year where healthcare models are being built around patients in the home to support patient autonomy.These three pillars of personalized healthcare are being made possible by disruptive technologies, wearables/implantables, social networks and analytic technologies to automate remote care. Wearables and biosensors allow patients to move anywhere without interfering with day to day schedules while allowing for optimized data collection.

Access to care anywhere has been a challenge and is becoming realized through providing cheaper wireless tools that takes it to far corners. Dr Gupta focused on the use of telemedicine for delivery of care and its utility for improving access. He endorsed it as a tool for providing care for those with limited healthcare accessibility and locally for more a mainstream solution to a larger healthcare problem. We have seen telemedicine become mainstream (more…)

A collation of recent items received – something for everyone

Thanks to Professor Mike Short, Mike Clark and Dr Nicholas Robinson, the following are items that have been drawn to the attention of this editor, plus a few he spotted himself:

We begin with a post from Dr Richard Windsor, aka Radio Free Mobile, a person whose opinions I greatly respect, arguing that Fitbit has chosen the perfect moment to float.

Next is an invitation to a Healthcare App – Peer to Peer Session at Swansea University on 20th May at The Institute of Life Science 2 – attendance is free, booking is here. Hours are stated  as 10.45 am – 12.00pm (ie noon).

Then we have a gentle reminder for the Royal Society of Medicine’s event on the 4th June entitled “Should patients manage their own care records?” As the RSM is a charity, our charges for a whole day of excellent speakers are a tiny fraction of what a commercial event would charge, and there’s no hustling.

After that we have the latest Morgan Stanley North American Insight, summarised as saying (more…)

The Future of Medicine – Technology & the Role of the Doctor in 2025 – a brief summary

The following is a brief summary of a joint Royal Society of Medicine/Institute of Engineering & Technology event held at the Academy of Medical Sciences on 6th May. The event was organised, extremely professionally, by the IET events team. The last ticket was sold half an hour before the start, so it was a genuine sell-out.

The speakers for the event were jointly chosen by this editor and by Prof Bill Nailon, who leads the Radiotherapy Physics, Image Analysis and Cancer Informatics Group at the Department of Oncology Physics, Edinburgh and is also a practising radiological consultant. As more of those invited by Prof Nailon were available than those invited by this editor, the day naturally ended up with a strong focus on advances in the many aspects of radiology as applied to imaging & treating cancer, as a surrogate for the wider examination of how medicine is changing.

The event began with a talk by Prof Ian Kunkler, Consultant Clinical Oncologist & Professor in Clinical Oncology at the Edinburgh Cancer research Centre. Prof Kunkler began by evidencing his statement that radiotherapy delivers a 50% reduction in breast cancer reappearance, compared with surgery alone. He stressed the importance of careful targeting of tumours with radiotherapy – not an easy task, especially if the patient is unavoidably moving (eg breathing) – Cyberknife enables much more precise targeting of tumours as it compensates for such movement. Apparently studies have shown that 55% of cancer patients will require radiotherapy at some point in their illness.

This was followed by Prof Joachim Gross, Chair of Systems Neuroscience, Acting Director of the Centre for Cognitive Neuroimaging & Wellcome Trust Senior Investigator, University of Glasgow, talking about magnetoencephalopathy (MEG), which enables excellent spatial & temporal resolution of the brain. However it currently uses superconducting magnets that in turn require liquid helium, so is very expensive to run. He then showed an atomic magnetometer which apparently is developing fast and will be a much cheaper alternative to MEG – he expects people will be able to wear sensors embedded in a cap soon. He then went on to show truly excellent graphics on decoding brain signals with incredible precision; he explained that the 2025 challenge is understanding how the different brain areas interact. Finally he described neurostimulation, using an alternating magnetic field with the same frequency as brain waves to change behaviour; whence the emergence of neuromodulation as a new therapy. Both exciting, and just a little scary.

Dr David Clifton, Lecturer, Dept of Engineering Science & Computational Informatics Group, University of Oxford, followed with a talk on real-time patient monitoring. He began by explaining the challenges that clinicians face with this wall of patient data coming towards them: only “big data in healthcare” enables all the data generated by patients to be analysed to identify the early warning signals that are so important to minimise death and maximise recovery. (more…)