
Medical Law in Italy
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Inhalt
- Intro
- Title Page
- Copyright Page
- The Author
- Table of Contents
- List of Abbreviations
- Preface to the First Edition
- Preface to the Second Edition
- General Introduction and Overview
- Reference 1
- Chapter 1. General Background of the Country
- §1. Geography and Climate
- §2. Population
- §3. The Political and Judicial System
- §4. Population and Vital Statistics
- §5. Health Status
- §6. Social and Cultural Values Regarding Health
- §7. The Constitutional Principles Underlying the Protection of Health
- I. Health as a Fundamental Right
- II. Autonomy and Human Dignity
- III. The Role of Healthcare
- Chapter 2. Medical Law Versus Health Law?
- §1. Definition and Functions of Medical Law
- §2. Sources of Medical Law
- I. Sources
- II. European Union Law
- III. National Sources
- §3. The Role of Codes of Professional Ethics
- Chapter 3. The Healthcare System
- §1. History and Evolution of the Italian Healthcare System
- I. From Unification to WWII
- II. From the Post WWII Era to 1978
- A. Department of Health
- B. The Mutual System
- III. From the Institution of the NHS to Date
- §2. The Actual Organization of the Healthcare System and Its Planning
- I. The National Level
- II. The Regional Levels
- III. The Local Structure
- §3. Eligibility, Covered Benefits and Actual Access
- I. Essential Levels of Assistance
- II. Rationing Instruments
- §4. The Financing of Healthcare
- I. Historical Evolution and .
- II. . and the State of the Art
- III. Financing and Purchasing Services
- §5. Integrating Public Healthcare Coverage Insurance
- §6. Territorial Services and Healthcare Protection
- I. Delivery of Services (Persons)
- II. Delivery of Services (Structures)
- A. Main Services and Organization
- B. Specific Services and Related Strategies
- C. Pharmacies
- Part I. The Medical Profession(s) and the Healthcare System
- Chapter 1. Access to the Medical Profession
- §1. Medical Education
- I. Historical Note and Overview
- II. Constitutional Competence
- III. Undergraduate Medical Education
- IV. Graduate Medical Education
- V. Continuous Education in Medical Science
- §2. Licensing of General Practitioners and Medical Specialists: Postgraduate Medical Education
- §3. Manpower Planning: Freedom of Establishment
- Reference 2
- Chapter 2. Practice of Medicine
- §1. Legal Conditions for the Practice of Medicine
- I. Historical Note (and Interplay with Other Healthcare Professions)
- II. Healing Arts and Medicine
- III. Legal Monopoly of Physicians
- A. Legal Conditions for the Practice of Medicine
- 1. Legal Diploma
- a. Exemption from the Legal Diploma
- i. Mutual Recognition
- b. The Recognition of Professional Activities
- i. General Overview
- ii. Recognition of Professional Activities in Italy
- iii. Recognition of Professional Certificates Obtained in Italy and the EU
- iv. Recognition of Study Certificates Obtained in Extra-Communitarian Countries
- B. Visa
- 1. Exemption from the Visa
- 2. Withdrawal of the Visa
- C. Inscription on the List of the Order of Physicians
- §2. The Practice of Medicine and Health-Related Professions
- I. General Introduction and Discipline
- II. The Practice of Medicine and the NHS
- A. Primary Care
- B. Ambulatory Care
- C. Secondary/Inpatient Care
- III. Specific Medical Activities
- A. Preventive Medicine
- B. Self-care
- C. Taking of Blood: Venepunctures
- D. Radiographies
- E. Blood Pressure Measuring and the Use of Other Simple Measuring Appliances
- F. Eye Examination and the Measuring of Eye Deviations
- G. Psychoanalysis and Psychotherapy
- H. Group Therapy
- I. Acupuncture
- J. Written and Oral Advice and Recommendations
- Chapter 3. Illegal Practice of Medicine
- §1. Legal Definition of the Offence
- §2. Who Is an Unauthorized Person (Criminal and Civil Consequences)
- §3. The Conduct
- §4. Sanctions
- Chapter 4. Control over the Practice of Medicine
- §1. The Order of Physicians
- I. Historical Note
- II. Registration on the List of the Order
- A. Obligation to Register on the List
- B. Exceptions
- 1. Nationals of EC Member States
- 2. Military Doctors and Physicians Working Exclusively for the NHS
- C. The Obligation to Register and the Freedom of Association
- D. Competent Provincial Council
- E. Refusal or Delay of Registration
- F. Registration after Being Struck Off the Register
- G. Removal from the List
- III. Disciplinary Competence of the Order of Physicians
- A. Control over the Observance of the Rules of Professional Ethics
- 1. General Description of the Disciplinary Competence
- 2. Rules of Professional Ethics and Standards of Discretion, Probity and Dignity
- a. The Code of Professional Ethics
- b. Legally Determined Rules of Professional Ethics
- c. Normative Authority of the Provincial Councils
- d. The Precedent Authority of Disciplinary Decisions
- e. Advice of the Provincial Councils
- f. Advice of the National Council
- 3. Limitations to the Disciplinary Power of the Provincial Councils
- a. Non-interference in Fundamental Freedoms
- b. Duty to Motivate Decisions
- 4. Disciplinary Sanctions
- a. Possible Disciplinary Sanctions
- b. Consequences of a Disciplinary Sanction
- c. Regarding the Right to Vote and to Be Elected
- d. Regarding the Right to Practise Medicine
- 5. The Disciplinary Procedure and Article 6 of the European Convention on Human Rights
- a. The Applicability of Article 6 of the European Convention on Human Rights in Disciplinary Proceedings
- b. The Public Character of Disciplinary Proceedings
- c. Hearing within a Reasonable Time
- d. Right to Challenge the Members of Councils
- 6. Disciplinary Procedure Before the Provincial Councils and the Appeals Councils
- IV. Organs of the Order of Physicians and Their Function
- A. Provincial Councils
- 1. Composition
- 2. Functions
- B. The National Council
- 1. Composition
- 2. Functions
- §2. Medical Ethics Committees
- I. General Remarks
- II. Ethics Committees in Hospitals
- A. Composition of the Committee
- B. The Competences of the Committee
- III. The National Committee on Bioethics
- A. Composition of the Council
- B. The Competences of the Council
- Chapter 5. Medical-Related Accidents and Compensation
- §1. The Medical Act and Its Legitimacy
- I. Consent to Contract Versus Consent to Medical Treatment
- II. Legitimate Medical Intervention and the Limits of Consent: Damages for Lack of Consent
- §2. Professional Liability
- I. Introduction and History
- II. Civil Liability
- A. Classification of Physician Liability
- B. Contents of the Physician's Duty
- C. The Basis of Liability and Burden of Proof
- 1. Fault
- 2. Causation
- 3. Damages
- D. Aspects of Vicarious Liability
- 1. Liability of Hospitals and ASL for the Acts of Their Medical Staff
- III. Criminal Liability
- A. Medical Acts Resulting in Personal Injury or Death (Crimes)
- B. Medical Acts Resulting in Crimes Against Individual Freedoms
- 1. Private Violence and Procured Incapacity
- 2. Kidnapping
- 3. Professional Medical Negligence
- §3. Special Indemnization Programmes
- I. Compensation for Victims of Vaccinations
- A. History
- B. Discipline
- II. Compensation for Victims of Blood Transfusions
- A. History
- B. Discipline
- III. Other
- Reference 3
- Chapter 6. Quality Assurance and Risk Management
- §1. Quality Assurance and Risk Management: Introduction
- §2. The Notion of Risk Management
- §3. Regional and National Interplay
- §4. Risk Management, Insurance and Liability
- §5. Quality Assurance and the Role of Order of Physicians
- §6. Quality Assurance and Internal Managing Controls
- §7. Healthcare-Associated Infections (HCAI)
- Part II. The Physician-Patient Relationship Within and Outside the Healthcare System
- Chapter 1. General Description
- §1. Rights and Duties of Patients and Physicians
- I. The Rights of Patients
- A. The Duty of the Patient to Cooperate
- B. The Right to Quality Care
- C. The Right to Free Choice
- D. Rights Related to Information about the State of Health
- 1. The Right to Information about One's State of Health
- 2. The Right Not to Know about One's State of Health
- 3. Relinquishing the Right to Information
- 4. Not Informing Based on the Physician's Initiative (the Therapeutic Exception)
- E. The Right to Give Consent
- 1. The Right to Well-informed, Free and Prior Consent
- 2. Modes of Giving Consent
- 3. Content of the Information
- 4. Presumed Consent in Cases of Emergency
- F. The Right to Refuse or Withdraw Consent
- G. Compulsory Treatments
- H. Rights Related to the Patient's Medical Record
- 1. The Right to a Medical Record
- 2. The Right to Add to the Medical Record
- 3. The Right to Access
- 4. The Right to a Copy
- 5. Access by Next of Kin after the Death of the Patient
- I. The Right to Protection of Privacy and Intimacy
- J. The Right to Representation in the Event of Incompetence
- K. The Right to Lodge a Complaint
- II. Medical Obligations in General
- A. The Legal Duty to Help
- 1. Rules on the Practice of Medicine
- 2. Article 593 of the Criminal Code
- 3. Article 328 Criminal Code (rifiuto di atti d'ufficio. Omissione) Refusal to Perform Official Functions: Omission
- 4. Rules on Emergency Medical Care
- B. Respect for the Privacy of the Patient
- 1. General Rule for Processing Personal Medical Data
- 2. Exceptions
- 3. Guarantees with Respect to the Processing of Personal Health-Related Data
- 4. Rights of the Data Subject
- 5. National and Regional Electronic Data Records
- 6. Privacy or Other Concerns Related to Electronic Health Record Systems EHRS (Fascicolo Sanitario Elettronico, FSE)
- 7. Special Cases
- a. Prescriptions
- b. Processing of Genetic Data and Data Relating to Bone Marrow Donors (Article 90 DPA)
- c. Data Processed by Means of Cards (Article 91 DPA) and Data Banks or Registers of the NHS
- C. Duty of Medical Secrecy
- 1. General Principle
- 2. Exceptions
- a. Testimony in a Court or Before a Parliamentary Committee
- b. Statutory Obligations to Disclose Confidential Information
- 3. Notification of Criminal Acts
- 4. Consent of the Patient or Waiver
- 5. Deliverance of Medical Certificates to Third Parties
- D. Medical Fees
- 1. Right to Fees or Remuneration for Services
- 2. Amount of the Fee
- 3. Fee-Splitting
- E. Unlawful Enrichment
- Reference 4
- Chapter 2. The Physician-Patient Relationship: Specific Cases
- §1. The Minor Patient
- I. General Principles
- A. Children's Consent
- B. The Role of Parents (and Legal Representatives)
- C. Parental Denial of Consent
- D. Information
- II. Cases of Exclusive Child Consent
- III. Cases in Which Child Consent Is 'Forbidden'
- IV. Special Cases
- A. Mandatory Vaccinations
- B. Blood Transfusions
- C. Cancer Treatments
- D. Compulsory Sampling of Biological Materials (Treaty of Prüm)
- §2. Interdiction, Non-(Fully)-autonomous Patients and 'Ammnistrazione di Sostegno'
- §3. The Mental Patient and Involuntary Placement
- I. Legal Framework
- II. Involuntary Placement in a Mental Hospital
- A. Admission for Observation
- 1. Simple Procedure (Non-emergency Cases)
- 2. Emergency Procedure
- 3. Practical Modalities of the Admission for Observation
- B. Prolonged Stay (TSO)
- C. Compulsory Treatment Outside the Hospital
- D. ASO and TSO for Minors
- III. The Rights of an Involuntary Placed Mental Patient
- IV. The Closing of Judicial Psychiatric Hospitals (Ospedali Psichiatrici Giudiziari, OPGs)
- §4. The Dying Patient
- I. Euthanasia
- II. Withholding or Withdrawing (Cessation) of Treatment
- III. Termination of Treatment (at the Request of the Patient)
- IV. Pain Relief and Palliative Care
- V. Physician-Assisted Suicide
- Chapter 3. Specific Activities
- §1. Termination of Pregnancy (Abortion)
- I. Short Overview of the Existing Legal Rules on Termination of Pregnancy
- A. Scope of the Law
- B. Conditions
- C. (So-Called) Therapeutic Termination of Pregnancy
- D. Father's 'Participation'
- II. Termination of Pregnancy by a Physician
- III. The (So-Called) Morning after Pill
- IV. Pharmacological Termination of Pregnancy (RU 486)
- §2. Sterilization
- I. Surgical Contraception
- II. Sterilization of Mentally Handicapped
- §3. Medically Assisted Conception
- I. Legal Framework
- II. Use of Donor Gametes
- III. Surrogacy
- §4. Human Genetics
- I. Overview and Possibilities
- §5. Removal and Transplantation of Organs and Tissues
- I. Scope of the Organ Transplantation Law
- II. Removal of Organs from Living Donors
- A. The Organ Transplantation (Donation) Law
- 1. General Conditions
- 2. Minor Donors
- 3. Informed Consent
- 4. Special Cases
- 5. Duties of the Physician Removing Organs
- B. Therapeutic Substances of Human Origin
- 1. Stem Cells and Cord Blood Banks
- 2. Transfusions and Blood Donation
- 3. Bone Marrow
- III. Removal of Organs after Death
- A. (Incomplete) Opting-Out System
- B. Ways to Object
- C. Establishment of Death
- D. Special Cases (Prohibitions in Law 91/1999)
- E. Anonymity
- F. Autopsies
- §6. Research
- I. Research with Human Beings
- A. Field of Application
- B. General Provisions Concerning the Protection of Subjects of Experiments
- 1. Respect for Ethical and Scientific Quality Requirements
- 2. Scientific Acceptability
- 3. Proportionality (Balance Between Benefits and Risks)
- 4. Informed Consent of the Subject
- 5. Primacy of the Human Being
- 6. Favourable Opinion of an Ethics Committee
- a. Definition of 'Ethics Committee'
- b. Ethics Committees in Hospitals
- c. Composition of the Committee
- d. The Competences of the Committee
- e. Task of the Competent Ethics Committee(s)
- f. Time Limits to Issue an Opinion
- g. Legal Value of an Opinion
- 7. Intervention of a Qualified Healthcare Practitioner
- 8. Liability Rules (Civil, Administrative and Criminal)
- 9. Insurance-Related Issues
- C. Specific Provisions for the Protection of Minors Participating in Experiments
- 1. Informed Consent of the Parents or the Guardian
- 2. Respecting the Explicit Will of the Minor
- D. Specific Provisions for the Protection of Adults Incapable to Consent to an Experiment
- E. Specific Provisions for the Protection of Persons Whose Consent Cannot Be Obtained Due to Emergency
- F. Research with Embryos In Vitro
- 1. Prohibited Procedures with Embryos In Vitro
- 2. Prohibition to Create Embryos In Vitro Solely for Research Purposes
- §7. Professional Freedom: Prescribing Drugs - Treatment with Drug-Substitutes
- I. Legal Framework of Professional Freedom
- II. Control over Professional Freedom
- III. Prescription of Drugs
- IV. Treatment with Drug-Substitutes
- V. Off-Label Prescriptions
- Selected Bibliography
- Index
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