New possibilities of digitalising processes continually enhance the "hunger for data” of various players. What is generally valid is also valid with reference to health and patient data. What benefits do new technologies bring – and what risks? And how can digital processes that generate additional data end up serving the growing need for patient safety? Those are topics at the MEDICA HEALTH IT FORUM in trade fair hall 15 within the scope of the world’s largest medical trade fair, MEDICA, from 16 to 19 November 2015 – being held from this year on with the new set of days from Monday to Thursday.
Collecting data is a method of choice to disclose problems with, for example, medical devices more quickly. In this connection, the ongoing work on the European Medical Device Regulation is a reaction to the worldwide scandal surrounding substandard breast implants by a French manufacturer. A new obligation entailing providing clear and individual identification markings on medical devices should become an integral part of these measures. This obligation to provide standardised identification is also being negotiated as a module of the free-trade agreement, "Transatlantic Trade and Investment Partnership" (TTIP). Currently, at least the USA are the forerunners concerning this. Their regulatory authority, the FDA, is already stipulating Unique Device Identification (UDI) to a certain extent. Harmonising international regulations is not much far ahead.
The following has been planned: Every individual device should be identified with an individual number and this number should be saved in a database that is accessible at a European level. There, all implants should be recorded along with their type, serial number, date and place of use, anonymous patient data and any possible incidents associated with them. Thereby, each medical device should be electronically readable. Although, it is anticipated to only initially require linear bar codes or "data matrices". After all, scanning medical devices marked in this manner could help hospitals and manufacturers to optimise procurement processes from the acceptance of goods at the warehouse all the way to their usage, as well as simplify their documentation and classification. But what about patient safety? According to the current status of legislation, the "radio frequency technology" (RFID) has only been provided as an additional option in the future. Professor Christian Dierks, lawyer at the law office, Dierks + Bohle, calls attention to the following: "Medical devices with a UDI can also be used for a further collection of data within the scope of clinical routine." Completely recording this data will be started in a different way. "Imagine that an individual with a femoral head implant could measure the amount of stress on his femoral head by means of an app.” A hip prosthesis with integrated sensors capable of wireless data transmission had already been conceived by the Fraunhofer Institute around two years ago. Dierks said that he was expecting the regulation to go into force next year. He pointed out that, when it is announced, a European regulation would also apply for all EU nations. Currently, collecting data for use in the field of patient safety is also being pushed forward, not only on a technical, but also a legislative level. The MEDICA HEALTH IT FORUM will also shed light on the details concerning the European role with regard to German health services.
Hinder big data? No, better to become a part of it and ensure that it is used sensibly!
Collecting and saving data, linking various sets of data as well as using and applying them also promise a great deal of progress in the field of medicine. However, they also bring about ethical and legal challenges. Just recently, the chairperson of the German Ethics Board, Professor Christiane Woopen made the following appeal: "Let’s work together so that people do not leave each other behind due to their sense of self-perception and lifestyle being characterised by biological elements and numbers, as well as on account of the efficiency hype and mania posed by optimisation, but allow them to come together with fulfilled lives.” It became clear in a symposium: The EU Commissioner for Digital Economy and Society, Günther Oettinger, is responsible for shaping the conditions in Europe in such a way that, on the one hand, big data is identified as a European research task and an engine for development within the field of health services and, on the other hand, possible dangers are averted. At a symposium of the ethics committee Mr Oettinger stated: "Technology can be designed. Prohibiting it and delaying it will not be possible." He has been requested to attend the MEDICA HEALTH IT FORUM. It is already definite that Professor Eckhard Nagel, member of the German Ethics Committee, will be host to the forum topic of "Big Data".
Contacting a doctor via video conference
Naturally, the relationship of a patient to his doctor will not remain unaffected by this digital revolution. Telemedical consultation is an example of this. It is still not welcomed everywhere – nevertheless, it is also gaining in significance, particularly in rural areas. Dr. Franz-Joseph Bartmann, chairman of the telematics committee of the German Medical Association, has explained that the application, "Patientus", is largely accepted in Schleswig-Holstein. Physicians can offer this to their patients as an integral part of medical-practice software. "Patientus" functions in a simple way: A patient can contact his physician from anywhere and any place within the scope of a private video conference. Thereby, the medical video conference between the doctor and patient cannot and should not replace a regular visit to the doctor’s office, but provide these visits with an optimal level of preparation, practically complementing them. In this way, the personal contact between patients looking for help and professionally competent doctors is made possible independent of location. The physical examination as well as the follow-up treatment still take place on site at the doctor’s office. The project will be presented within the scope of the MEDICA HEALTH IT FORUM.
Minister Wanka is going to be presenting a trendsetting development concept.
Of course, many health technology projects have not yet become so successful. Professor Johanna Wanka, Federal Minister for Education and Research, is going to present a new trendsetting development concept for medical informatics within the scope of the MEDICA HEALTH IT FORUM. The objective of the development concept is to improve patient care and research possibilities by means of innovative IT systems. Thereby, in past years, high through-put technologies have revolutionised health research. Today, large amounts of research data are generated in a very short time span. At the same time, with the increase in digitalisation in the field of medicine, more and more electronic data from the field of patient care are available. Together, these data have the potential to significantly improve the diagnosis and therapy of diseases. In order to take advantage of this potential, data from the field of research and patient care have to be merged and rendered into knowledge. A particular challenge lies in having to integrate various medical data types – for example, genetic information with a haemogram or a x-ray image. When interpreting new data, large amounts of professional literature, results and existing data deriving from biomedical and clinical research have to be taken into account. Ultimately, the newly gained knowledge must be prepared in such a way that doctors can derive the best-possible treatment for their patients.
Medical informatics is developing technical tools for all of these steps.
It describes, analyses, models and simulates medical processes with the object of generating new knowledge, optimising care and research procedures and supporting players in the field of healthcare. Innovative strength, competitiveness and the interconnection of our research and healthcare system will also continuously rely on efficient medical informatics. The development concept of medical informatics should contribute to strengthening the field of medical informatics research in Germany and sustainably improve patient care. German Federal Research Minister Wanka will be presenting the details of the development concept on 16 November in Düsseldorf at the MEDICA 2015 in Düsseldorf.
New opportunity for start-ups at the "eHealth Venture Summit"
In addition, the "eHealth Venture Summit” is entering a new round. Last year, the international format has already attracted 26 start ups, particularly from abroad, such as from America and Taiwan. Here, IT and investment are brought together. Within five minutes, start-ups presented their ideas on site. A high-ranking expert panel consisting of investors, industry and science assessed the ideas. The winner won a trophy with a video on presenting the product. Last year, ideas were presented, such as diabetes tracking or online physiotherapy by a young company from Israel that won with this idea.
The aforementioned examples show that: Also this year, the MEDICA HEALTH IT FORUM is offering an abundance of exciting topics, high-ranking speakers and a place for professional discussion over the entire frame of time the Forum and the MEDICA 2015 are taking place.
Information on MEDICA 2015 exhibitors, product information, news on companies and the programme of the accompanying conferences and forums, e.g. the MEDICA HEALTH IT FORUM and the MEDICA CONNECTED HEALTH FORUM, are available online at: http://www.medica.de.
Author reference: Dr. Lutz Retzlaff, freelance medical journalist (Neuss)