Collecting and linking data offer great opportunities – ethical and legal challenges represent the downside

New possibilities of digitalizing 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 held during MEDICA 2015. The world's largest medical trade fair will be held from November 16 - 19, 2015 at the fairgrounds in Düsseldorf, Germany – with new show days (Monday to Thursday) and will feature about 4,800 exhibitors from around the globe.

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 that entails providing clear and individual identification markings on medical devices should become an integral part of these measures. This obligation to provide standardized identification is also being negotiated as a module of the free-trade agreement, "Transatlantic Trade and Investment Partnership" (TTIP). Currently, at least the U.S. is the forerunner concerning this. Their regulatory authority, the FDA, is already stipulating Unique Device Identification (UDI) to a certain extent. Matching 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 optimize 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, says: "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. Prof. Dierks said that he was expecting the regulation to go into effect 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.

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