Objective - Video recording of surgery at patient request/consent, Status as of 9 August

Romanians want to know what to expect during surgery and to have any issues resolved as quickly and transparently as possible.

Enough people have recognized the importance of video recording surgeries; they recognized the benefits when, using laparoscope technology, they were shown video images of the interventions, making it easier for them to get and understand the explanations.

One of the goals of the project "Romanian patient - fair laws and maximum transparency" is to persuade the state to implement measures leading to the imposition of the practice of registration (in accordance with GDPR rules), in operating rooms, of surgical interventions, so that they can then be used, including for the patient benefit (further explanations in case of errors).

FACIAS, the Coalition of Organizations of Patients with Chronic Diseases in Romania (COPAC), and the Patients' College collaborate on the project.

Why did FACIAS decide to devote resources to this goal?

The goal was developed in response to complaints received from approximately 1000 citizens via the FACIAS questionnaire, as well as messages received. When FACIAS ran the project "Be informed, not abused!" for the Health component between April 2021 and February 2022, we were asked to support the following:

• Simple access to a list of personal medical expenses
• Easy access to the medical file
• ● Video recording of surgeries
• ● The dangers posed by intrahospital infections to patients, as well as the lack of transparency on the subject
• Non-application of laws due to lack of methodological application norms

Why do we believe it is necessary to make this Objective a reality?

• A database is created with images that can be used for research, teaching, or collaborative work
• It would reduce the number of deaths as a result of surgical errors.
• Images used in malpractice trials (today the trials consume a lot of time, the specialists are even colleagues of the doctors involved in the trials, errors may occur, but video recordings show the exact truth).
• Video cameras in operating rooms can improve both patient safety and surgeon performance. However, because doctors continue to be concerned that video recordings and data collection will be used against them in malpractice cases, the practice will take some time to be implemented.
• Medical malpractice can be reduced by using operating room cameras.
• ●ideo recordings of surgical procedures can be used to analyze operative performance, improve surgical education, and present cases to a larger group of plastic and reconstructive surgeons..

Situation Prior to the Project

The article "Objective - Video recording of surgical interventions at the request/with the consent of the patient" (https://facias.ro/elementor-13361/) contains all information related to the field of this objective.

The Ministry of Health, through Protocols, hospitals, and the Parliament are the institutions in charge of the majority of the field (if they would like to generalize this practice of video recording of surgeries).

We discovered that there are very few hospitals that record surgical interventions, obviously with the patient's consent, but the practice is not widespread. We have seen it most often in private hospitals, but we have also seen it in state hospitals.

In practice, we encounter the following scenarios:

The head doctor or surgeon can request to be filmed (if personnel/resources are available) or to take photos in order to show the patient later what he did or why he made a decision or another (the patient being under anesthesia)

Not all hospitals have the capability of filming surgical procedures.

Laparoscoapele sunt dotate cu card de flimare/memorie (deci, în cazul intervențiilor laparoscop este posibil)/ Medicul, dacă dorește, poate filma, reține imaginile

Legislation that only partially regulates the field of the Objective (it only mentions that the patient cannot be filmed without his consent, which is natural, and that the hospital can decide whether and what to do in relation to the patient):

• LEGE nr. 95 / 2006, art 171 (alin 1):https://legislatie.just.ro/Public/DetaliiDocument/71139

"The organizational structure of a hospital can include, as the case may be: departments, laboratories, diagnostic and treatment services, departments, technical, economic and administrative services or offices, pre-hospital assistance service and emergency transport, emergency reception structures and other structures approved by order of the Minister of Health".

• Legea nr. 46/2003, art 20: https://legislatie.just.ro/Public/DetaliiDocument/41483

"Article 20: The patient cannot be photographed or filmed in a medical facility without his consent, unless the images are required for diagnosis or treatment, or to avoid suspicion of medical malpractice."

What have we done until 8th of August?

We sent questions about the project to several institutions with management and legislative power in the field, including the Ministry of Health, the Health and Technology Committees of the Romanian Parliament and CNAS, the European Parliament's Health Committee, and the Specialized Directorate.

All of the submitted questions can be found at https://facias.ro/elementor-13361/. The answers are also posted on the website as we receive them.

To collect even more information from citizens, we created the Objective Questionnaire. You can fill out the questionnaire here:

https://docs.google.com/forms/d/e/1FAIpQLSfhVzu3ZAqIvvKu0zQfjZ9SUXQ-V0ghssoSF1OPq9AcYAz0bQ/viewform?usp=sf_link

What did the institutions tell us that we were unaware of?

• The Parliament's technology committees: they lack data and expertise, but if such a legislative project is presented to them, they will consider FACIAS requests.
• The request was redirected to the Ministry of Health by the Health Commissions.
• The request was redirected by CNAS (to the Ministry of Health because it is under the competence of the ministry).
• The following was sent to us by the Ministry of Health:
  
  It is not possible without the patient's consent. The exception is when the images are required for diagnosis or treatment, as well as to avoid suspicion of medical malpractice.Proposes us to send the inquiries to INSP, as well.
  Propune să ne adresăm cu întrebări pe subiect și INSP.
  
  Fiecare Stat Membru are proceduri individuale din care să impună obligativitatea înregistrării imaginilor, în sălile de operații, a intervențiilor chirurgicale.
  
  Nu se impune modificarea vreunui act normativ în vederea generalizării acestei practici.
  

• The European Parliament's Health Commission and the specialized Directorate issued a joint response: they directed us to the World Health Organization's Regional Office for Europe to see if it has data on how to proceed in other EU states (what legal norms - on request/ or default/ who finances).
  Ne-au direcționat către Biroul regional pentru Europa al Organizației Mondiale a Sănătății, pentru a verifica dacă dispune de date referitoare la cum se procedează în alte state UE, ce norme legale- la cerere/ sau default/cine finanțează)
  
  The European Commission's legislative proposal on the European Health Data Space (EHDS) would help to address some of FACIAS's concerns.
  
  There are no plans at the EU level to adopt legal instruments in this regard because it would be incompatible with the principle of subsidiarity, so it is up to each state.
  
  In terms of statistics on the number of deaths caused by surgical errors, Eurostat reports deaths according to their primary cause, based on OMS classification standards ("ICD-10"), but includes both deaths caused by malpractice and deaths caused by other types of errors, such as failure of medical devices (eg, pacemakers), which are not by definition malpractice cases. Furthermore, due to differences in reporting practices among Member States, country-specific data are incomparable.
  
  The European Commission's legislative proposal on the European Health Data Space (EHDS) would help to address some of FACIAS's concerns. The organization of health data (including collection, access, transfer, and use) within the EHDS would contribute to the improvement of health care, increase transparency of health data, and allow for more effective control of patient health data.
• The EHDS, along with other EU policies such as the AI Regulation, would allow patients to benefit from medical advances.

What actions have we proposed in support of the Goal until September 2022?

• The other requested responses are also being received and will be brought to your attention.

• We will compile the survey responses and publish the research results.

• We will hold an online public debate to which hospital representatives will undoubtedly be invited.

• We will continue to request that the practice of recording surgical interventions be expanded.
  

As is customary, we will keep you updated on all aspects of the "Romanian patient - fair laws and maximum transparency" Project.