Risk management and data transparency in relation to claims
Civil liability of hospitals, health and social care facilities and professionals
Criminal liability of professionals
Recourse action against professionals by hospitals
Mandatory insurance – new direct action against insurers
Procedural rules

Law 24/2017 on the management of healthcare risks and the liability of healthcare professionals was approved on February 28 2017. Some of the measures introduced – particularly those regarding civil procedure rules – are innovative and could be replicated in other areas of law to improve the efficiency of the judicial system.

Risk management and data transparency in relation to claims

Law 24/2017 focuses on the requirement that public and private hospitals:

  • establish "structural, technological and organizational resources"; and
  • implement risk management and internal audit functions that are typical of other regulated industries, such as banking and insurance.

Article 4(3) of the law focuses in particular on the completeness and transparency of data. Hospitals (both public and private) must collect and publish on their websites information relating to the compensation for damages paid as a result of errors and omissions in the previous five years.

Civil liability of hospitals, health and social care facilities and professionals

In order to overcome the interpretative uncertainties of Decree-Law 158/2012, Article 7 of Law 24/2017 clarifies that if a healthcare organisation (including health and social care facilities) "avails of the services of healthcare professionals, even if they are selected by the patient and are not employees of the organization", its responsibility is contractual and without prejudice to the concurrent tortious liability of the healthcare professional, even if the service is:

  • a clinical trial;
  • paid for by the National Health Service; or
  • rendered remotely via telemedicine.

In principle, healthcare professionals should now be exposed to different types of liability (ie, liability on contract or tort) depending on whether they:

  • operate within a hospital (private or public);
  • are sole practitioners; or
  • specifically undertook an obligation towards the patient.

Damage caused by hospitals, health and social care facilities – both public and private – and healthcare professionals will be examined based on the criteria set out in Articles 138 and 139 of the Code for Private Insurances.

Under Article 7(5) of Law 24/2017, the provisions concerning the civil liability of hospitals, health and social care facilities and professionals are mandatory.

Criminal liability of professionals

Under Article 5 of the law, the criminal liability of professionals for fatal events or personal injury due to negligence will be excluded in the event that the professionals complied with the best practices set out by scientific organisations and public and private institutions approved by the ministry.

Within 90 days from the new law's entry into force (which has not yet been published in the Official Gazette), the ministry will establish a register in which the abovementioned scientific organisations and the public and private institutions will be listed. These organisations and institutions will indicate the guidelines representing the best practices to be followed by professionals, which will be reviewed every two years.

Recourse action against professionals by hospitals

Under Article 9 of Law 24/2017, recourse actions by hospitals against professionals regarding claims arising from their errors and omission are:

  • limited to cases of wilful and gross negligent misconduct; and
  • time barred for one year from the date of issue of the final decision against the hospital or for one year from the date of payment by the hospital to the damaged party under an out-of-court settlement agreement.

Further, in all events, the quantum of the recourse action against the professional must not exceed three times his or her gross annual salary for three years after the final decision accepting the recourse action against the professional, the latter must not be assigned to a more senior position in the hospital.

Under Article 9(5) of the new law, the Court of Auditors' has jurisdiction against professionals working for public hospitals and public health and social care facilities regarding errors or omissions that have damaged public finances.

Mandatory insurance – new direct action against insurers

Article 10 of Law 24/2017 introduces the general obligation that hospitals and public and private health and social care facilities have insurance that covers claims made by the injured parties not only against them, but also against professionals working for them, including professionals in charge of training and clinical trials. The provision also applies to professionals acting as sole practitioners, paid by the National Health Service or practising telemedicine. Hospitals and public and private health and social care facilities must also have an insurance policy covering the civil liability of healthcare professionals working for them against third parties.

In turn, professionals working outside hospitals and public and private health and social care facilities – as well as within the latter as sole practitioners or – who avail themselves of the organisation to perform the obligations directly assumed with the patient must have their own personal insurance policy, including cover of the recourse actions by the hospital.

In general, healthcare professionals who work for public or private hospitals or health and social care facilities must have their own insurance policy covering liability for gross negligence.

The minimum requirements hospital and professional policies must be established by separate decrees issued within 120 days from Law 24/2017's entry into force.

Under Article 11 of the law such policies must provide:

  • coverage for losses suffered within 10 years before their conclusion and reported to the insurer within the policy period; and
  • a 10-year discovery period in case of cessation of the professional activity for whatever reason, which covers claims received for the first time after the cessation of the activity and arising from errors and omissions made during the policy period as well as the 10-year retroactive period indicated above.

The injured party will take direct action against the insurer of the hospital, the private or public health or social care facility or health professional. The issue of whether and to what extent coverage can be opposed against the injured party will be addressed in a separate decree which establishes the minimum requirements of the policies concerned.

Such direct action is subject to the same statute of limitation applicable to the action against the hospital (ie, 10 years from the date on which the relevant action took place) or the professional (ie, five years from the date on which the relevant action took place).

The insurer will have recourse against the insured within the limits established by the separate decree setting out the minimum requirements of the policies concerned, which, as indicated above, will be issued 120 days after the law's entry into force.

Procedural rules

Law 24/2017 introduces the following innovative measures aimed at increasing the efficiency and speed of the proceedings, namely:

  • Actions before courts will be admissible only if evidence is given that the parties' preliminary attempt of mediation failed.
  • Preliminary mediation will therefore be mandatory and must be carried out through the so-called 'technical appraisal' pursuant to Article 696bis of the Code of Civil Procedure. This is a type of pre-trial investigation conducted by court-appointed experts. The mediation process and the technical appraisal must be completed within six months.
  • Experts will be registered in a specific list and must be specialised in the area under dispute.
  • Failing mediation, the court proceedings will be governed by Article 702bis of the Code of Civil Procedure, which is a fast-track proceeding.
  • All individuals or entities interested in the claim, including the insurers, must be parties to the preliminary mediation process.
  • The party that failed to attend the mediation process will be charged with:
    • the defence costs borne by the other parties and the expert costs, regardless of whether it is a losing or winning party in the subsequent proceedings; and
    • a fine which will determined by the court on a case-by-case basis.

For further information on this topic please contact David Marino, Marco Dimola, Chiara Cimarelli or Vito Bisceglie at DLA Piper Italy by telephone (+39 02 80 61 81) or email ([email protected], [email protected], [email protected] or [email protected]). The DLA Piper website can be accessed atwww.dlapiper.com.