• February 12, 2021

GDPR APPLICATION IN MEDICAL PRACTICE. OPPORTUNITIES AND BARRIERS. EMA Parnters

GDPR APPLICATION IN MEDICAL PRACTICE. OPPORTUNITIES AND BARRIERS. EMA Parnters

GDPR APPLICATION IN MEDICAL PRACTICE. OPPORTUNITIES AND BARRIERS. EMA Parnters 622 186 gdpr4h-project.eu

This meeting, chaired by Vincenzo Costigliola, President of the European Medical Association (EMA), which is a partner of the GDPR for Health Project, https://gdpr4h-project.eu/ , took place as a webinar managed on MEET, with the participation of several members of EMA, February 8th 2021.

This summarized preliminary report is developed by the EMA Director for media, e-learning and e-medicine, integrating the main points developed in the discussion.

The General Data Protection Regulation (GDPR) 2016/679, directly applicable in all Member States by 25 May 2018 requires healthcare organizations to re-think about their data flows and how they handle and monitor patient data. This is needed to make sure they complies with the National and International regulation. Such very important step toward has the goal of building a more digital and inclusive society.

Dr. Costigliola described how its application is already increasing the distance and the promptness of feedback in the relationship between individual patient and physician. Diseases, and much more events that arise in urgency or with important psychological implications, can only rarely wait to be inserted into forms and templates.

The current digital architecture is still quite schematic if not frankly old-fashioned, so that solicits the doctor to a clinical approach based more on formalities rather than on needs deriving from the patient’s interview, visit and study.

The guarantees may become, and are already becoming, barriers for the direct physical contact and intervention in medical practice. Rules, forms and templates to be filled are actual slowing and distancing tools, and for the menaces of controversies, and the ever-looming threat of legal disputes is becoming an obstacle, as demonstrated by the large number of complaints in all European countries. Regardless of the relevance and outcome of these complaints, the effect on the mutual trust between the doctor and patient, and therefore on the final efficacy of many necessary medical acts, is highly disadvantageous.

The permanent confrontation between the many doctors Google and the doctor with immediate ethical, professional and legal responsibility for the patient who relies on him has become a source of positive stimulus, but also a trigger for useless discussions and behaviors full of fake news and irrational approaches, or for proposals and behaviors frankly fanatic or superstitious.

In such conditions, it is safer for the doctor to fall back on quasi-bureaucratic positions, leaving the patients to a fictitious participatory management of their health or illness. The Ethical call for privacy respect and transparency of processes and of data management, while is very appropriate for health organizations and facilities, as well for industries and research institutions, may seriously impair the freedom and the confidentiality of the doctor-patient relationship, challenging the limited possibilities of smaller family practice and limited resources facilities. The need of agile models and systems, well known and applied in several fields and tasks involving computer science, should be taken in greater account, as it is needed and possible.

Among the sustainable mitigation strategies, EMA Members recommend:

1. It is necessary to provide a clear and safe legal umbrella for the whole phase of meeting, interview and visit that the doctor must carry out in all contexts, but especially in small clinics and with minimal IT facilities.

2. National or local health systems, public or private, must be able to provide all context support to the individual professional, who must not be called upon to implement and control the many data, as appropriately required by EU directives and national laws.

3. Greater surveillance and limitation of all health-related activities that are illegally carried out by people who do not have the necessary qualifications (degrees and qualifications), nor an adequate level of professional and scientific updating and certifications are required.

4. The accuracy of the GDPR rules is clearly and appropriately designed and addressed to non-small health organizations and to clinical trials. These last, which are vital for the development of drugs and medical devices, has been and will be a real advance in scientific and ethical civilization. In this role, the European contribution is of pivotal relevance to build skills for life, and improve confidence and interest in learning for successful participation of all medical professionals in all the health aspects of our society.[CP1] 


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