Webinar “Digital Health in the EU – current state, future directions & GDPR updates”

Webinar “Digital Health in the EU – current state, future directions & GDPR updates”

You can access now the recording of our November online joint webinar of the Tele-Cardiology Working Group of the International Society for Tele-Medicine and eHealth (ISfTeH) and the European Commission representatives, held on 7 november 2019.

You can download the sildes of the presentation below.

Top speakers discussed about the future directions of the European Union digital health sector and also update us on general data protection regulations (GDPR):

  • Mme. Ioana-Maria GLIGOR (European Commission-Head of European Reference Networks and Digital Health Unit)
  • M. Dalibor VOJTA (European Commission) 

Also visit our NEW website (www.telecardiologywg.isfteh.org), and share information on our Facebook group, on Twitter and on our LinkedIn group. The Tele-Cardiology Working Group of the International Society for Telemedicine & eHealth is a working group dedicated to all advances in cardiology that involve artificial intelligence, computers, cardiac devices and IT. Thank you for sharing this post to your friends interested in eHealth and eCardiology.

#digitalhealth #digitalacute #digitalcardiology #medicine #ehealth

If you encounter problems during the registration, please email us at telecardiologywg@isfteh.org

What I learned from the ESC Digital congress in Tallinn!

What I learned from the ESC Digital congress in Tallinn!

The ESC Digital congress was a bold and successful initiative of the European Society of Cardiology, and took place in Tallin, a few days ago. The location was not chosen by hazard, as Estonia has 99% of health data digitized and 99% of prescriptions are digital. Prof. Viigimaa exposed the architecture of the Estonian Electronic helth system in a comprehensive presentation at the beginning of the congress.

Current organization of digital healthcare was reviewed by Prof. Martin Cowie in an excellent presentation, where he highlighted that we need to identify barriers and find appropriate solutions on this emerging sector. We will always find at the center of our care the patient and his family, and this aspect should not be overlooked or forgotten, especially in this rapid-digitalized era.

Patient care, patient empowerment and nursing issues were also addressed by Prof. Donna Fitzimons and ACNAP President-Elect Lis Neubeck, with accent on developing the short and longer path to action which have in center the patient and the nurse (as midlevel team member). Digital nursing sessions drawed a lot of constructive comments, with Donna Fitzimons opinioned that if the patient is art ease at using online interaction with a “digital” nurse (avatar talking and guiding the patient by means of AI), then we should use this technology mainly to prevent, and not to treat. Find below the interesting slides from the presentations and their link to full presentations.

A very interesting session addressed the issue of preparing the healthcare force for the digital future chaired by ACCA President Susanna Price. Even though some solutions have been highlighted in a important scientific paper, like as the need for a culture of learning (develop extensive learning environment, encourage innovation and dare to fail), building a strong learning infrastructure and developing a multi-professional and collaborative approach to learning, these approaches are unachievably in the current state of the medical system in Europe, where most of the current medical personnel are disengaged or over-fatigued, doctors and nurses are burned-out.

Does technology make things worse for the medical workers? Can artificial intelligence and automation ease things? See all the debate here.

The same issue was addressed in another session. While trying to find solutions for the future, present issues of healthcare professionals and the digital boom relate to lack of trust and poor experience with new technologies, difficulty to interact with technology, fear of change. This is maybe where artificial intelligence could make the difference, as it can improve healthcare efficiency and delivery and could replace human involvement in some tasks of the medical industry, as suggested Dr. Casado Arroyo. However, for the moment, present algorithms are not completely in their mature stage.

Cybersecurity was a hot topic. Dr. Avi Fischer resumed some of the important cautions to take in reducing cybersecurity risks, such as:

  • sharing responsibility between stakeholders-healthcare facilities, patients, providers, and manufacturers of medical devise;
  • cybersecurity should be a priority during the design and development phase of the medical device and the issue should be addressed in a “Bolt-On to Integrated” fashion;
  • if a vulnerability is found, communication and coordinated actions between stakeholders and healthcare facilities are vital. Development and involvement of government structures to assure security is very important.

The participants also expressed the urgent need for developing secured protocols to transmit data.

A special session to electronic medical record (EMR) can be accessed here. The consensus was that even though EMR are an efficient data base that can help health professionals in decision making, it is also time consuming. A new concept that consists on “less keyboard, more patient contact” should be adopted, because according to one study, for every hour physicians provide direct clinical face time to patients, nearly 2 additional hours is spent on EHR and desk work within the clinic day, and outside office hours, physicians spend another one to two hours of personal time each night doing additional computer and other clerical work. Dr. Nico Bruining highlighted an important limitation of EMR used in Europe (vs. US), notably in Europe we use more than 30 languages that makes data collection difficult, and that should probably be aimed by a future Horizon 2020 project.

Augmented, mixed and virtual reality discussions were divided into cardiologist-related and patient-related. The 3 terms are intercorrelated and should not be confused one with another, here is their meaning and a schematic representation:

  • Virtual reality (VR) immerses users in a fully artificial digital environment.
  • Augmented reality (AR) overlays virtual objects on the real-world environment.
  • Mixed reality (MR) not just overlays but anchors virtual objects to the real world.

The 2 main applications in medicine targets the patients and of course the doctors.

  • For patients, one of the presenters suggested that VR will do for patient education what Google Maps has done for navigation, thus it “will transform learning experiences by better retention and recall, it will improve patient journey and will determine behavioral change by challenging health beliefs through impactful experiences”.
  • For doctors, Dr. Dariusz Dudek explained how a pioneer programe of mixed reality that is currently used in Poland helps cardiologists choose a better punction site for TAVI, with expectancy in the very near future to have VR mask that will allow cardiologists to have echo, CT and eventually other 3D reconstructions in the corner of their eyes, while a cardiac intervention is taking place. Other important applications are stroke recovery and cardiac rehabilitation.

Over-utilization of medical devices.

One of the worries highlighted was that this new technology could cause anxiety in healthy fit subjects, translating into unnecessary consultations either by their general practitioner either by their cardiologist, as presented by Prof. Martin Cowie. 57% of subjects from the “Apple heart” study thought to seek medical attention after having an alarm from a smart device.

Even though wearables and connected devices impact sometimes positively our daily lives (sleep apnea analysis app, selfie to quantify oedema app, accelerometers incorporated into devices that quantify daily effort, smartphone-based blood pressure measurement by transdermal optimal imaging, etc), Dr. Klaus Witte highlighted that there is increased concern that wearables and connected devices impact negatively the society by increased (but unnecessary) cost to the consumer and increases (but unnecessary) cost to the medical system (by over-investigating a healthy person thus launching a battery of tests like holter ECG, echocardiography, stress test). With this in mind, there was a unanimous consensus that medical wearables and connected devices should target special groups of populations if we want to avoid death, strokes or hospitalizations and the clinical benefit of these kind of devices should be carefully thought and evaluated.

Conclusions

Digital technology can help healthcare by providing new tools for diagnosis and therapy delivery, redesigning clinical pathways, individualized risk stratification and individualized care, patient empowerment, support to precision medicine (thus fewer medical errors), and telemonitoring. Digital technology and connected devices (tablets, wearables, apps) will enhance decision making of health professionals only if there is a direct link towards a clinical benefit, and maybe they would have a huge impact if they could be directly linked also to EMR. In real life, adoption of digital technology in healthcare depends on validation, easy integration of workflow & prescription pathways and ability to reduce work.

Consumers could think that by using digital technology and connected devices, they take control over their health; this is partially false because alarms issued by devices could translate into unnecessary consultations and increased cost to overall health system by doing unnecessary tests in otherwise healthy subjects. Narrowing the indications and the target population for the use of this devices should be a priority.

And finally, some punctual issues need rapid and clear solutions: stricter security protocols should be incorporated in data transmission, regulations should be adopted for all digital technology (there are too many devices and few regulations), the huge amount of data (that is collected from all digital technology) needs to be transformed into information.

Tele-Cardiology in 2018 – quick review

From new smart stethoscopes to digital health investments and studies looking at the use of new technologies, 2018 was a remarkable year for innovation in telecardiology. The biggest news, however, came from Apple receiving FDA clearance for an algorithm detecting atrial fibrillation and an ECG to be built into its latest Apple Watch series. Here is a summary of some of the key developments in the area from the past year, presented in a timely manner.

January: New products

M3DICINE launches AI-enabled, wireless stethoscope called Stethee

At the beginning of the year, Australian company M3DICINE launched a wireless stethoscope called Stethee that works with an accompanying app, available for both iOS and Android. M3DICINE says Stethee captures, filters and amplifies the sounds of a patient’s heart or lungs, and the audio is then sent to users’ Bluetooth-enabled devices or wired headphones. The platform’s AI engine, called Aida, analyzes heart and lung sounds to build personal biometric signals, according to a statement from the company. Aida also tags geolocation and environmental data, which, encrypted and anonymized, can be reported back in the form of quantitative reports (data that is clinically actionable), and clinicians can view them through an online portal. The company said it worked in the development of Stethee with designers and engineers from the Massachusetts Institute of Technology and clinical experts from Mayo Clinic, among others. M3DICINE received FDA clearance for the product in 2017.

Source: Company announcement

February: Investment

Eko Devices raises $5m after receiving FDA clearance for its Duo smart heart monitor

Californian company Eko Devices announced in February that it raised $5m in a Series A funding round, after securing 510 (k) FDA clearance in 2017 for its smart heart monitor Duo, a combined digital stethoscope and ECG. Clinicians can use the portable cardiac device as a screening tool or prescribe it to outpatients – Duo pairs with an app to enable remote monitoring and diagnosis by a specialist. In 2015, the company received FDA clearance for the Core smart stethoscope.

Source: Company announcement

March: Research

AliveCor announces results from two studies

In March, AliveCor unveiled the findings of two studies at the American College of Cardiology’s 2018 Annual Scientific Session, looking at the use of its portable ECG devices.

A Cleveland Clinic study set out to identify whether the company’s medical device accessory KardiaBand, which is FDA-cleared, for Apple Watch could differentiate between atrial fibrillation and normal heart rhythm. Findings indicated that KardiaBand detected atrial fibrillation and normal synus rhythm with an accuracy (interpreted with 93 percent sensitivity and 84 percent specificity) that they said was “comparable to clinicians interpreting the same ECGs”.

A second study indicated that the device paired with AI technology could detect hyperkalemia (commonly associated with congestive heart failure and chronic kidney disease). More than two million ECGs linked to four million serum potassium values reportedly collected between 1994 and 2017 and prospective data from an AliveCor smartphone ECG device were used in the development of the AI algorithm. AliveCor said this could be commercialised through the KardiaBand for Apple Watch at the time. In September, it announced that its KardiaK Software Platform had achieved FDA Breakthrough Device Status, which means that the FDA will consider it on a track for accelerated clearance that is specific for devices “demonstrating the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions”. AliveCor planned at the time to use the solution for home-based hyperkalemia detection to help support patients with kidney disease.

Source: Company announcements

March: Research

App from University of Turku, Finland detecting atrial fibrillation

A mobile app developed at the University of Turku’s Department of Future Technologies in Finland detected atrial fibrillation with a 96 percent accuracy in a study of three hundred patients with heart problems – half with atrial fibrillation – carried out by the university and the Heart Centre of the Turku University Hospital. The project was carried out as a blind study, with the hospital sending the University measurement data for analysis. In a press announcement issued in March, it was explained that the app could be commercialised through the University spin-off company Precordior.

Source: University announcement

April: New products

Steth IO unveils digital stethoscope integrated into a smartphone’s case

Steth IO launched in April a digital stethoscope integrated into a smartphone’s case that works with an accompanying app, allowing clinicians to listen and measure heart rates or lung sounds by holding the mobile up to a patient’s chest. The device received FDA clearance in 2016.

Source: Company announcement

June: Research

Leveraging behavioral economics to support patients with cardiovascular disease

A study published in the Journal of the American Heart Association in June found that combining wearable devices with “personalized goal-setting” and a financial incentive led to an increase in levels of physical activity among ischemic heart disease patients involved in the trial. However, researchers found that wearables alone were not effective in generating improvements in physical activity levels.

The study included 105 patients with ischemic heart disease, taking place over a period of 24 weeks, but researchers noted that limitations of the study included the fact that the only levels of physical activity evaluated were based on steps. However, they argued that the findings indicated that “digital health interventions that leverage insights from behavioral economics offer a promising approach to change health behaviors among patients with cardiovascular disease”.

Source: Journal of the American Heart Association study

August: Device integration

Cardiogram heart health app and Garmin wearables integration

In August, Garmin International announced that its wearable devices featuring optical heart rate would become compatible with the Cardiogram heart health app. Using data from wearables, the Cardiogram app provides insights to help users understand the effects of activity and sleep on their overall health. Working with the Department of Cardiology of the University of California, San Francisco, Cardiogram has combined data from optical heart rate sensors and an AI-based algorithm called DeepHeart developed by them for the detection of major conditions. Clinical studies indicated that DeepHeart had demonstrated that it could detect the following: atrial fibrillation, sleep apnea, hypertension, and diabetes.

Cardiogram co-founder Johnson Hsieh explained in a statement that there had been high demand for the app to support Garmin wearables, integrated through an application programming interface (API) to enable access to insights generated.

Source: Company announcement

September: Regulatory news, new products

Apple delving further into healthcare with first FDA clearance

In September, Apple made waves in the digital health world after announcing that it had received FDA De Novo clearance for an algorithm to detect atrial fibrillation from heart rate data and an ECG to be built into its Series 4 Apple Watch by adding electrodes to the digital crown and the back of the device. Users can take an ECG in around half a minute. The ECG waveform and its classifications, along with any other symptoms recorded, are saved in the Apple Health app, and a PDF can be shared with doctors.

Source: Company announcement

September: JAMA Network Open study

Findings from a study released by JAMA Network Open in September last year showed that, in a cluster randomized trial of 326 patients with uncontrolled hypertension, home blood pressure telemonitoring combined with pharmacist management lowered blood pressure more than usual care in the first 18 months. However, results indicated significantly lower blood pressure in the group that received the intervention for up to 24 months and not through the entire 54 months. Researchers argued in the study that “long-term maintenance strategies may be needed” in order for the effects to be sustained over the course of multiple years.

Source: JAMA Network Open study

November: Research

AliveCor announced in November that a research version of its mobile technology could identify STEMI (ST-elevation myocardial infarction), after a study found that it was able to detect the condition with “good correlation and high sensitivity”, according to a press announcement, compared to a standard 12-lead ECG or traditional ECG technology. Two months before that, AliveCor announced that it was working on a six-lead smartphone ECG, labelled Project Triangle.

Source: Company presentation and interview with US outlet CNBC

December: Investment

AI-focused Myia Labs start-up raises $6.75m in seed funding

Myia Labs announced towards the end of 2018 that it secured $6.75m in seed funding, and the interesting part was that the round saw participation from the American College of Cardiology. The start-up uses data from wearables to monitor patients with chronic illnesses, examining metrics such as heart rate, blood pressure and others, and applies machine learning to issue alerts to those caring for them in case major changes are identified. 

Source: Company announcement

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