What you need to know about Germany’s new DiGA fast tracking for health apps

May 7, 2021 | by

Research2Guidance (R2G) has published a new report on the new, and faster, German regulations for obtaining approval for digital health applications. 2019’s Digital Healthcare Act (DVG) introduced measures to speed up approvals for digital apps so that they can be prescribed by German doctors and reimbursed through German public health insurance, which covers 90 percent of the population.

The Digital Health Applications process (DiGA) requires a review by the German Federal Institute for Drugs and Medical Devices (BfArM) to prove that apps and digital tools improve patient care. Other criteria include:

  • Data protection legislation and information security conformance
  • Interoperability
  • CE-certification as a medical product (in the lowest-risk class for now)

The R2G report details not only the DiGA Fast Track process and the current status of DiGA adoption, but also what it takes to create a successful German market entry strategy with innovative distribution channels. If you have a digital health app or tool, and you’re targeting 80 million Germans, this report is a Must Read. R2G page, Mobihealthnews, HealthcareITNews

Short Takes 20 Nov: Doro Eliza social alarm in UK, R2G diabetes market study, KOMPAÏ Robotics update, Bluestream Health integrates LanguageLine translation, and Optum’s 18

November 20, 2020 | by

Why does this whole year feel like we are Pauline in Peril, all tied-up, with an Evil Man menacing us while the Train barrels down the tracks? Nonetheless, there are bites of news to be consumed, even though this year’s Thanksgiving in the US will be at best a muted one, and the Grinch may be stealing Christmas.

Doro remains ‘on a tear’ with new product introductions for the UK. The Doro Eliza (right) is a 4G/digital IP compatible social alarm/”smartcare” hub, with a modern design that connects to telecare accessories. The modern design has HD audio on the speaker for personal alarms, and also connects to smoke detectors, fall sensors, security cameras, and pill dispensers. Already introduced in Europe, its timing is part of the transition from analogue to digital telecare for 1.7 million UK telecare users as telecom moves to full digital by 2025. Release.

If your business is in diabetes care and the apps that assist them, Research2Guidance’s study and forecast, “The Global Digital Diabetes Care Market 2020: Going Beyond Diabetes Management” will be of interest. The 91-page report covers a global picture of growth from 2008 projecting out to 2024, as well as digital solutions, their segmentation, and competition. For instance, from 2019 to 2024, the number of diagnosed diabetics with access to smart devices is set to increase from 109 million to 180 million. It includes profiles of 10 countries. Priced from €3,290, so it will set you back a bit. More information here. 

We missed updating you on KOMPAÏ Robotics, which Editor Emeritus Steve Hards first covered in 2011. Their latest developments were earlier this year as their assistance/companion robot finally debuted for sale–right in the middle of the pandemic. This Pulse article recounts the road for CEO Vincent Dupourqué from 1975 to the third version of KOMPAÏ.

LanguageLine, which is a long-time provider of language translation services live to in-patient and acute care settings, announced an integration with Bluestream Health’s virtual visits. With a single click, a Bluestream user can access audio and video interpretation in 240 languages and over 13,000 interpreters. LanguageLine also assists with deaf and hard-of-hearing users. Bluestream provides whitelabeled telehealth services to approximately 50,000 providers. LanguageLine has headquarters in California, with offices in Taiwan and London.  Release

And finally, Optum’s 18. Optum Ventures, the funding arm of UnitedHealth Group’s Optum, has invested in a large number of healthcare ventures this year, nearly all with a health tech or AI spin. It’s neatly distributed internationally and between Series A through C, with UK companies like Oxford VR (VR used for therapies, no connection to Oxford Medical Simulations) as part of a $12.5 million Series A, Germany’s Kaia Health with a $26 million Series B tranche, and US companies like LetsGetChecked as part of a $71 million Series C. Not quite Ocean’s 11, but Optum’s bet a lot more than Danny Ocean got from those casinos in 1960. Becker’s Health IT.

Advances in 2017 which may set the digital health stage for 2018

January 3, 2018 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/12/Lasso.jpg” thumb_width=”100″ /]Our second Roundup takes us to the Lone Prairie, where we spot some promising young Health Tech Advances that may grow up to be Something Big in 2018 and beyond. 

From Lancaster University, just published in Brain Research (academic/professional access) is their study of an experimental ‘triple agonist’ drug developed for type 2 diabetes that shows promise in reversing the memory loss of Alzheimer’s disease. The treatment in APP/PS1 mice with human mutated genes used a combination of GLP-1, GIP, and Glucagon that “enhanced levels of a brain growth factor which protects nerve cell functioning, reduced the amount of amyloid plaques in the brain linked with Alzheimer’s, reduced both chronic inflammation and oxidative stress, and slowed down the rate of nerve cell loss.” This treatment explores a known link between type 2 diabetes as a risk factor and the implications of both impaired insulin, linked to cerebral degenerative processes in type 2 diabetes and Alzheimer’s disease, and insulin desensitization. Other type 2 diabetes drugs such as liraglutide have shown promising results versus the long trail of failed ‘amyloid busters‘. For an estimated 5.5 million in the US and 850,000 in the UK with Alzheimer’s and other dementias, and for those whose lives have been touched by it, this research is the first sign of hope in a long time. AAAS EurekAlert—Lancaster University release, video

At University College London (UCL), a drug treatment for Huntington’s Disease in its first human trial has for the first time safely lowered levels of toxic huntingtin protein in the brain. The group of 46 patients drawn from the UK, Canada, and Germany were given IONIS (the pharmaceutical company)-HTTRx or placebo, injected into spinal fluid in ascending doses to enable it to reach the brain starting in 2015 after over a decade in pre-development. The research comes from a partnership between UCL and University College London Hospitals NHS Foundation Trust. UCL News release, UCL Huntington’s Research page, BBC News

Meanwhile, The National Institutes of Health (NIH)’s All of Us program, part of the Federal Precision Medicine Initiative (PMI), seeks to track a million+ Americans through their medical history, behavior, exercise, blood, and urine samples. It’s all voluntary, of course, the recruitment’s barely begun for a medical research resource that may dwarf anything else in the world. This is the NIH program that lured Eric Dishman from Intel. And of course, it’s controversial–that gigantic quantities of biometric data, genomic and otherwise, on non-genetic related diseases, will simply have diminishing returns and divert money/attention from diseases with clear genomic causes–such as Huntington’s. Oregon Public Broadcasting.

Let’s not forget Google DeepMind Health’s Streams app in test at the Royal Free NHS Foundation Trust Hospital in north London, where alerts on patients at risk of developing acute kidney infection (AKI) are pushed to clinicians’ mobile phones, (more…)

d-Lab opens Challenge to transform use, governance of Personal Health Data

May 5, 2017 | by

d-Lab is calling for international healthcare innovators to take a good, hard look at how we can use, secure and increase access to personal health data (PHD). In this Challenge, d-Lab is seeking innovative ideas, projects, and solutions that consider wider uses of PHD for patients and research, such as:

  • innovative modes of PHD governance
  • future use in health and medical research
  • inclusion of new types of data, such as from wearables
  • contribution to wellbeing and aging solutions
  • innovative business models that assure the long-term sustainability of PHD usage and governance

The Challenge opened this past Tuesday and closes on 27 June, with winners announced in September. There will be a maximum of two
winning proposals that will lead to the setting up of a maximum of two partnerships and two pilots. See here for d-Lab’s website and here for the terms and conditions PDF. d-Lab is a program of Mobile World Capital-Barcelona. The Challenge is supported by Clinic Barcelona, Research2Guidance, and TicSalut.

Is startup funding actually going to startups? Where are all of them, anyway?

May 3, 2017 | by | 1 Comment

Markus Pohl of Research2Guidance, in two successive blog postings, asks provocative questions on Whither Startup Funding. This Editor will attempt to summarize his key points but read both articles to get the real impact–and surprise.

  • There is $4 bn annually managed by accelerators and incubators that invest in health–over $1 bn in 1st Quarter–but only a portion of this funding goes to startups. (The $4 bn / $1 bn are not footnoted, but they are the Rock Health investment numbers [see TTA 10 Jan and 11 Apr])
  • After subtracting for ongoing investments in portfolio companies, operational costs, and ex-healthcare investments, this funding for startups is realistically closer to $300 million
  • This money will only be spent if there are startups that qualify for the 340+ accelerator and incubator programs
  •  According to the last year’s R2G survey, mHealth App Developer Economics, there are 58,000 mobile health app developers. 15,000 are considered to be in the startup phase (eligible for an accelerator or incubator program). But “The majority of mobile app developers in healthcare tend to struggle on the finance and business side.”
  • The surprise: there are not enough quality startups for the available programs, even though most startups apply to more than one.
  • “Accelerators struggle to build up a high-quality selection funnel.” They suffer from lack of awareness, especially regional accelerators.
  • Accelerators and incubators will be adapting to startup candidate scarcity–or fail–within the next two years. Narrowing their focus to certain healthcare niches and focusing on their target may help. (But there may be a bubble here–Ed.)

More than US$4bn funds raised by accelerators & incubators investing in health. Why is only a small portion landing in the hands of start-ups? and Most digital health accelerator and corporate start-up programs must refocus to survive

For TTA readers, the R2G sponsored 7th Annual mHealth App Developers survey is here. It takes about 10-15 minutes to complete, so grab a cup of coffee or tea, and go! The survey is still open for about two weeks more. It is most applicable to mobile health app developers, project managers, publishers, co-founders, digital health experts, influencers, opinion makers, and investors–in other words, our Readers! Anyone who completes the survey will receive a copy near the end of 2017.

The R2G App Developer Economics Survey is supported by a stellar roster of distribution partners, accelerators, and media partners including Bayer, PCHAlliance, Health 2.0, dhaca…and TTA.

Readers invited: 7th Annual mHealth App Developer Economics Survey

April 13, 2017 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/04/mHealth-Economcis-2017-Banner-1.png” thumb_width=”175″ /]Research2Guidance is once again inviting TTA Readers to participate in R2G’s annual mHealth App Developer Economics Survey–their largest to-date study on the current status and future trends in digital health.

What’s the question?: The competition in the digital health market is heating up. 2016 saw the highest numbers of new entries into the mHealth app market since 2013. Yet consumer demand is not growing at the same speed; note the download growth curve! What are the business strategies in digital health that will be successful in 2017 and beyond?

In return for participating in the survey, you will not only have your say, but also more:
— See how your digital health project performs against market average
— Enter into the R2G prize draw to win an Apple Watch 2
— Receive the R2G report at no charge, which will cover digital health solution downloads, revenues and budgets, distribution channels, connectivity, country preference and much more.

The special link to the survey is here. Average time is 10-15 minutes, so grab a cup of coffee or tea, and go! The survey will be open till May (date TBD) and be published by Q4 this year. The survey is most applicable to mobile health app developers, project managers, publishers, co-founders, digital health experts, influencers, opinion makers, and investors–in other words, our Readers!

The R2G App Developer Economics Survey is supported by a stellar roster of distribution partners, accelerators, and media partners including Bayer, PCHAlliance, Health 2.0, dhaca…and TTA.

Analysis of an underserved market: only 0.2% of migraine sufferers use migraine apps

February 2, 2017 | by

research2guidance has published a short article on how migraine sufferers constitute an underserved market, and how present apps do not meet their needs. Here is an opportunity for app developers and companies to address a common and often near-intractable pain that affects everyday life. The author is David Ireland, Research Analyst, r2g Berlin.

Migraine is the third most prevalent illness in the world affecting 1 billion people worldwide^. However, this demographic of migraine sufferers is heavily underserved by mobile health applications, with only 0.2% of migraine sufferers using a migraine app*. But why? A major opportunity exists for an application with the right strategy, and the right balance of features and functionalities to lead the market, while having a positive impact on the health of migraine sufferers.

According to the Migraine Research Foundation (2017), migraine is the sixth most disabling illness in the world. More than 4 million people suffer from chronic migraine attacks every day. U.S. healthcare and loss of productivity costs are estimated to be around US$36 billion annually; just the cost of brain scans of headache sufferers alone comes in at around US$1 billion per year. Migraines are responsible for a huge loss in productivity, rendering 90% of sufferers unable to function normally, costing U.S. employers US$13 billion, and 113 million work days in 2016.

Far from being just a bad headache, migraine attacks can cause a diverse range of disabling symptoms such as severe pain, nausea and visual disturbance. While medications exist to help treat symptoms, migraine sufferers need to carefully manage their medication intake, while monitoring risk factors such as food, sleep and triggers to treat, and prevent the condition from becoming chronic. Tracking medication is critical, as most chronic migraine sufferers are a result of medication overuse^.

The main promise of migraine apps is to provide migraine sufferers with a way to better manage their condition, decreasing the chances of migraine attacks, of headaches intensifying into migraines, and of the condition becoming chronic. To achieve this, migraine apps could provide users with the following (in no particular order of priority):

  • Log-books / diaries: recording migraine events to help the user better understand their condition, while allowing for a better communication between the user and GP
  • Reporting: for analyzing and summarizing the users’ behavior, triggers, risk and symptoms, while allowing for a better communication between the user and GP
  • Information repository: peer-reviewed educational content aimed at educating the user on neurological conditions, and how best identify, treat, manage and prevent them
  • Pattern recognition: based on historical user data to notify the user of high-risk scenarios (more…)

6th Global mHealth App Developer Economics Study–closing soon!

May 25, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/05/surveybannerv10.jpg” thumb_width=”200″ /]research2guidance’s 6th Global mHealth App Developer Economics Study is still open (closing end of May) and interested in the opinions of those in the health tech field. Take 15 minutes or so and take the survey (link here). You’ll also receive a free copy of the survey once completed, and a chance to win either an Apple Watch or a Samsung Gear. Last year, over 5,000 industry experts did, including our TTA readers. Our article on the survey’s preliminary results in April. TTA and DHACA (Editor Charles, Managing Director) are media partners for this study. Hat tip to r2g’s Ralf Jahns.

6th Global mHealth App Developer Economics Study–early results in

April 8, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/r2gprelimresultsinfographv2.jpeg” thumb_width=”200″ /]research2guidance has shared with the Editors some of the preliminary results of the 6th Global mHealth App Developer Economics Study. Currently at 2,000 participants and open till the end of May (click here to take the 15 minute survey), it has grown to be the largest global market study of the sector. (Last year’s study topped out at more than 5,000 industry respondents and is available as a free download here.) For their time, respondents can view initial results upon completion of the survey, after publication in 2nd Quarter receive a copy of the report and be automatically entered into their prize draw of an Apple Watch or Samsung Gear.

Many of the results to date are neatly summarized in the infographic at left and below:

  • 61 percent believe mHealth solutions can cut costs through therapy adherence
  • 65 percent believe mHealth adoption could save costs by shortening or avoiding hospital visits
  • Market potential as a distributor: app stores still lead (61 percent) but half believe health insurers are now second. Doctors and hospitals trail at 42 percent and 38 percent respectively.
  • Most positive impact: following up and monitoring of conditions; information provision; diagnosis and treatment
  • But goals are still distant: 53 percent of respondents revealed they had only “partly achieved their goals”. 4 percent claimed their mHealth “dreams came true”. (Perhaps those who had their companies acquired? — Ed.)

r2g release.

TTA and DHACA (Editor Charles, Managing Director) are media partners for this study. Hat tip to Sean Phillips of r2g. Previously in TTA, Charles’ original article.

Seeking input from mHealth stakeholders: 6th Global mHealth App Developer Economics Study

February 14, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/02/r2g-logo-blue.jpg” thumb_width=”150″ /]Research2guidance is inviting stakeholders from across the industry to share their experiences of working with and in mHealth to find out what is proving successful today and what might prove successful in the near future. Last year, over 5,000 industry experts participated in this study for the largest study on the global mHealth market. (TTA was a media partner for last year’s study.)

For the 6th edition of the Global mHealth App Developer Economics study, they are keen to find out:

  • Which business models are most effective to succeed in mHealth today?
  • Which app categories are most successful in meeting the demands of both patients and investors?
  • What does the relationship between Health Insurers and mHealth look like in 2016?

In return they are offering participants:

  • The chance to view initial results immediately after completing the survey
  • A free copy of the mHealth App Developer Economics 2016 report

Take the survey here. 

For anyone who has not read it yet, the excellent 2015 survey is here. (Their key findings from last November are here.) R2G press release 

165,000 apps, 3 bn downloads and counting: global mHealth apps study

November 25, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/11/mHealth-Developer-Economics-2015.jpg” thumb_width=”200″ /]The results of the fifth annual mHealth App Economics survey are out. Our Readers were invited to participate back in March when it was sponsored by German research firm research2guidance in collaboration with mHealth Summit Europe and HIMSS and kicked off at the Riga meeting in May.

Major apps stores reported more than 165,000 mHealth apps published by 45,000 companies, and projected 3 billion downloads by close of 2015.  Some other key findings from R2G do surprise:

  • The target for apps is DTC–chronically ill patients–with their hospitals as #2. Physicians are important, but less so than last year’s survey.
  • App publishers aims appear altruistic. 53 percent of mHealth publishers claim that their main motivation is to help people improve their medical conditions. However, 60 percent aren’t reaching their goals yet mainly due to low reach. The vast majority of apps (62 percent) mark up less than 5,000 annual downloads. (See the chart below for some possible reasons why)
  • Diagnostic apps lead in anticipated business potential until 2020. And app publishers have added medical professionals to their team.
  • What app publishers find works to change behavior is not gamification. What does: integration of provider feedback or dialogue.
  • Yet providers, such as doctors and nurses, are seen as the most threatened group by mHealth solutions.
  • A scant 3 percent of mHealth publishers generate more than $1 million–and they are far more focused on sales and brand awareness than their brethren which make little. (chart)

(more…)

Calling all medical app developers – please help with “Guidance and Advice Most Needed by App Developers”

June 24, 2015 | by

UK-based PatientView, and its sister organisation, myhealthapps.net, in conjunction with Germany-based Research2Guidance, and the App Quality Alliance, need your answers to a survey to help inform the creation of guidelines designed to improve the quality and focus of health, wellness, and disability apps. This will be be launched at the European Health Forum Gastein in October 2015, which is attended by hundreds of health policymakers as well healthcare industry representatives.

The survey opens with a handful of short, anonymous, profiling questions. It then moves quickly on to 14 questions about issues that are absolutely key to the developers of health, wellness, and disability apps.

The survey will probably take a maximum of 20 minutes to complete. The results will be anonymised. If you would like a copy of the collated survey results (which will include the views of respondents who are other healthcare stakeholders), please indicate your interest at the end of the survey.

To enter the survey, please do click on Guidance and Advice Most Needed by App Developers.

Many thanks, in anticipation.

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

May 14, 2015 | by | 1 Comment

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.”[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/05/EU-segments.png” thumb_width=”400″ /]

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. 

Participate in the 2015 Global mHealth App Developer Economics Study

March 5, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/03/2015-mHealth-App-Developer-Economics-study-banner.jpg” thumb_width=”250″ /]TTA readers are invited to participate in the fifth annual mHealth App Economics survey, sponsored by research2guidance in collaboration with mHealth Summit Europe and HIMSS. The study will look at the mHealth app market, how apps generate revenue, how behavior could be changed by apps, the use of APIs and sensors as well as other related topics–and is the largest industry survey on mHealth app development.

Click here to go to our exclusive link and participate in the survey. The survey is available till 26 April. Share your opinions and experience on how mHealth apps impact healthcare delivery now and in the next five years. Plus, every participant will receive the chance to win one of five free entry tickets to the mHealth Summit Europe in Riga, Latvia 11-12 May, where the results will be presented; a free copy of the 2015 report as well as the possibility to see initial results after completing the survey. Download link for the 2014 study (PDF).

TTA is a media partner of the 2015 Global mHealth App Developer Economics Study, and was a media sponsor of this year’s US mHealth Summit.

2014: a few quotes

January 2, 2015 | by

As a coda to yesterday’s review of our predictions for 2014, here are a few quotes that particularly struck this editor as of interest in 2014, sometimes because of what was said and sometimes because of who was saying it – it’s left to the reader to decide which.

Arthur L. Caplan, Director of Medical Ethics at the New York University Langone Medical Center at the end of an interesting piece in the New York Times on the finer points of genetic testing said:

If you want to spend wisely to protect your health and you have a few hundred dollars to spare, buy a scale, stand on it, and act accordingly.

Three months later, Anne Wojcicki, the founder of 23andme – one of the genetic testing organisations mentioned in the last clip – was quoted in this Medcity News piece as saying: (more…)

Free research report on the state of mHealth apps

October 28, 2014 | by | 2 Comments

research2guidance has published the 2014 (fourth) edition of mHealth App Developer Economics with an in-depth market analysis on the current status and future impact of mHealth app publishing. Some findings of the global study:

  • Revenue achieved $2.4 billion in 2013 and projected to be $26 billion by 2017, derived primarily on a subscription model from services.
  • Surprisingly, mHealth app publishers and “wannabes’ (planning to release soon) by the numbers target chronically ill patients (31 percent) with the top being diabetes and obesity, with the greatest potential cost benefit on nonadherence and hospital readmission–then health and fitness (28 percent). The B2B market presently is composed primarily of physicians, targeted by 14 percent of app developers, but the five year outlook is that physicians and hospitals will develop into the primary distribution channel. (more…)