Cardiac devices and key developments in the field from the past year were discussed. From new smart stethoscopes (Stethee, Eko, Steth IO) to digital health investments, artificial intelligence and studies looking at the use of new technologies, 2018 was a remarkable year for innovation in tele-cardiology:
- Big steps have been made on algorithms that detect atrial fibrillation (AF) and integrated devices used as diagnostic tools. In September, Apple made waves in the digital health world after announcing that it had received the Food and Drug Administration (FDA) clearance for an algorithm to detect AF 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. Another device equally to be considered in this setting is the KardiaBand (FDA-cleared device from the AliveCor company); it detected atrial fibrillation vs. normal sinus rhythm with an accuracy said to be “comparable to clinicians interpreting the same ECGs” (93% sensitivity and 84% specificity). AliveCor announced in November that a research version of its mobile technology could identify 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.
- There is more and more proof 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 one trial1; the study that included 105 patients with ischemic heart disease, however, researchers found that wearables alone were not effective in generating improvements in physical activity levels.
Artificial intelligence in medicine and cardiology with focus on diagnosis and symptom checker websites was another hot topic. Symptom checkers and online diagnosis tools are available now on several important medical websites2-5. Patients can access them via internet in order to have a rough assessment of their symptoms. It must be highlighted that these self-diagnosis tools are aimed at helping the clinician in decision-making and are not ment to be used by the patient alone without medical supervision, even though these online tools have a high accuracy in posing a definite diagnosis. Their ideal use is during a tele-consultation session with a doctor, with the patient providing all important details about his medical problem following all the steps that the diagnostic tool requests. Once the doctor has interviewed the patient, the online diagnostic tool helps the doctor in the decision making, offering the most probable diagnosis or providing a list of several differential diagnosis; the decision and diagnosis is the doctors’ to make after interviewing the patient online.
The European Union General Data Protection Regulation (GDPR) generated a lot of interest. Health data is defined under article 9 of the GDPR as any data relating to the past, current or future physical or mental health status of a subject, thus this represents very sensible data. In the current era of increasing medical data collection and transfer, a lot of questions arise: which information has to be provided before health data is processed, is consent always needed and how exactly should it be obtained, how long can health data can be stored before it needs to be deleted, and how can collected data be used for other resources (scientific research, big data analysis, etc)? Health data also applies also to the data collected by cardiac implanted electronic devices such as implantable defibrillators, pacemakers, cardiac resynchronization therapy devices and implantable loop recorders. Very recently, a joint Task Force established by the European Society of Cardiology (ESC) - Regulatory Affairs Committee and the European Heart and Rhythm Association had several meetings in order to analyze what are the legal implications for patients and clinicians regarding data produced from remote monitoring. Recommendations will be available during the ESC Congress 2019.
Categorizing the digital health interventions, a very interesting subject, was also debated. Why is this important? Because the different communities working in digital health (some of which are include governments, stakeholders, technologists, clinicians, implementers, network operators, researchers, donors) do not have most of the times a mutually understandable language. In consequence there is a need for a shared and standardized vocabulary, in order to identify gaps and duplication, evaluate effectiveness, and facilitate alignment across different digital health implementations. A comprehensive overview of the subject can be found here7.
New Apps! Among hundreds of medical Apps that arise every year, there is one that attracted my attention: The Portuguese PEM Móvel Application (Prescription Electronica Medica), presented by Mr. Henrique Martins. Why is it special? Because first of all it has been financed by the Portuguese National Health System ant not by the Industry, thus allowing fast adaptation to the doctor’s and patient’s need, shortcutting the profit-oriented reflex of current Apps and focusing more on the patient. Developed in 2012, the PEM is the computer application for electronic prescription of medications and is available in the public and private hospital setting, in order to reduce the number of manual prescriptions and to have a strong digital signature. From this derived the PEM Móvel App which allows electronic prescription from mobile devices such as phones or tablets. This mobile App allows the elaboration of a drug prescription using a mobile phone by the doctor, allows access by pharmacies to the prescription data and integrates into a single process all the actors: users, prescribers and pharmacies. Great idea!
Overall this was an excellent congress for those passionate about eHealth and tele-cardiology, more details regarding the complete program and the recorded broadcasts can be found here.