
Medical Law in the Netherlands
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Content
- Intro
- Title Page
- Copyright Page
- The Author
- Table of Contents
- List of Abbreviations
- General Introduction
- Chapter 1. The General Background of the Country
- §1. Geography and Climate
- §2. Population
- §3. Political and Judicial System
- §4. Population and Vital Statistics
- §5. Social and Cultural Values Regarding Health
- Chapter 2. General Description of the Healthcare System
- §1. General Overview of the Dutch Healthcare System
- §2. Regulation of the Healthcare System
- §3. Financing of Healthcare
- §4. Health Insurance
- Chapter 3. Medical Law
- §1. Definition and Functions of Medical Law
- §2. Sources of Medical Law
- Part I. The Medical Profession
- Chapter 1. Access to the Medical Profession
- §1. Medical Education
- I. Historical Note
- II. Undergraduate Medical Education
- III. Graduate Medical Education
- §2. Licensing of Medical Specialists and GPs: Postgraduate Medical Education
- I. Medical Specialists
- II. General Practitioners
- III. Practitioners of Social Medicine
- §3. Manpower Planning: Freedom of Establishment
- Chapter 2. Practice of Medicine
- §1. Historical Note
- §2. Procedures in the Field of Medicine and Healthcare
- §3. Constitutive Registration and Professional Titles
- §4. Competence of Physicians
- §5. Reserved Procedures
- Chapter 3. Control over the Practice of Medicine
- §1. Disciplinary Liability
- I. Historical Note
- II. Disciplinary Norms
- III. Disciplinary Boards
- IV. Disciplinary Sanctions
- V. Procedural Aspects
- VI. Measures on Account of Incompetence
- §2. Professional Liability
- I. Introduction
- II. Civil Liability
- A. Classification of Physician's Liability
- B. Contents of the Physician's Duty (Standard of Care)
- C. The Basis of Liability and Burden of Proof
- 1. Fault
- 2. Damages
- 3. Causation
- D. Aspects of Vicarious Liability
- 1. Liability of Hospitals for the Acts of Their Medical Staff
- 2. Physician's Liability for Medical Activity of Other Persons (Strict Liability)
- E. Limitation or Exclusion of Liability
- III. Criminal Liability
- §3. Quality Assurance
- §4. Medical Ethics Committees
- Part II. The Physician: Patient Relationship
- Chapter 1. General Description
- §1. Rights and Duties of Patients and Physicians
- I. The Medical Treatment Agreement Act
- A. Scope of Application
- 1. Medical Treatment Agreement
- 2. Patient
- 3. Medical Actions
- B. The Right to Information
- C. The Right Not to Know
- D. The Right to Give Consent
- 1. General Remark
- 2. Necessary Consent of the Patient
- 3. Written Consent upon Request of the Patient for Invasive Actions
- 4. Presumed Consent for Non-invasive Actions
- 5. Exceptions
- 6. Sanctions
- E. The Right to Advance Refusal of a Treatment
- F. The Right to Withdraw Consent
- G. Rights Related to the Patient's Medical Record
- 1. The Right to a File and to Add Documents
- 2. The Right to Destruction of the File
- 3. The Right to Access and the Right to a Copy
- H. The Right to Protection of Secrecy
- I. The Right to Privacy
- J. The Right to Representation in the Event of Incompetence
- 1. The Incapacitated Patient Is Placed under Protective Mentorship for Adults (Article 1:450-1:462 Civil Code) (Legal Representative)
- 2. The Incapacitated Patient Is Not Placed under Protective Mentorship
- a. Representation by an Appointed Representative
- b. Representation by a Not-Appointed Representative
- c. Obligations of the Physician and the Representative
- K. Obligations of the Patient
- L. Termination of the Medical Treatment Agreement
- M. Mandatory Law
- II. The Quality, Complaints and Disputes in Healthcare Act
- A. Introduction
- B. The Right to Good Care
- C. The Right to Choice-Information
- D. The Right to be Informed of Incidents
- E. The Right to an Effective and Low-Threshold Complaints and Disputes Procedure
- 1. Complaints
- 2. Disputes
- III. The Act Containing Additional Dispositions Regarding the Treatment of Personal Data in the Care Sector
- IV. Implementation of the Cross-Border Healthcare Directive
- A. National Contact Point
- B. The Right to Receive Choice-Information
- V. The Medical Examinations Act
- VI. The Legal Duty to Help
- VII. Protection of the Health Data and Genetic Data of the Patient
- A. Field of Application
- B. Processing of Data Concerning Health and Genetic Data
- 1. Prohibition of Processing of Data Concerning Health and Genetic Data
- 2. Derogation from the Prohibition on Processing of Data Regarding Health and Genetic Data
- a. Compliance with the Principles Relating to Processing of Personal Data
- b. One of the Following Justifications Applies
- c. Comply with Member States' Further Conditions
- C. Rights of the Data Subject
- 1. The Right to the Protection of Personal Data
- 2. Information to be Provided Where Personal Data Are Collected from the Data Subject
- 3. The Right of Access by the Data Subject
- 4. Right to Rectification
- 5. Restricted Right to Erasure of Personal Data Regarding Health of Genetic Data ('Right to Be Forgotten')
- 6. Right to Restriction of Processing
- 7. Restricted Right to Portability of Data Regarding Health or Genetic Data
- 8. Right Not to be Subject to Automated Individual Decision-Making, Including Profiling
- 9. Right to Transparent Information and Communication Concerning Rights of the Data Subject
- 10. Right to Lodge a Complaint and to an Effective Judicial Remedy
- 11. Right to Be Represented
- 12. Right to Compensation and Liability
- D. Modalities for the Exercise of the Rights of the Data Subject
- E. Data Protection by Design and by Default
- F. Communication of a Personal Data Breach to the Data Subject
- G. Data Protection Impact Assessment
- H. Designation of a Data Protection Officer When Data Regarding Health or Genetic Data are Processed on a Large-Scale
- VIII. Duty of Medical Secrecy
- A. General Principle
- B. Exceptions
- 1. Privilege of Non-disclosure in Court
- 2. Statutory Obligations to Disclose Confidential Information
- 3. Conflict of Duties
- 4. Consent of the Patient
- 5. Issuing Medical Certificates to Third Parties
- IX. Medical Fees
- Chapter 2. The Physician: Patient Relationship in Specific Terms
- §1. The Minor Patient
- I. The Patient Has Not Yet Reached the Age of Twelve Years
- II. The Patient is at Least Twelve Years but Not Yet Sixteen Years
- III. The Patient Has Reached the Age of Sixteen Years
- §2. The Mental Patient and Involuntary Admission and Treatment
- I. The Legal Framework
- II. The Compulsory Mental Healthcare Act
- A. Definition of Compulsory Care
- B. Criteria for Compulsory Care
- C. The Self-Binding Declaration
- D. The Compulsory Care Authorisation
- E. The Crisis Measure
- F. Temporary Compulsory Care in Case of Emergency
- G. Right to Complain and Compensation of Damage
- H. The Patient Advocate
- III. The Care and Coercion Act
- A. Definition of Coerced Care
- B. Rights of the Client
- C. Involuntary Admission and Stay in an Accommodation
- §3. The Dying Patient
- I. Euthanasia and Physician-Assisted Suicide
- A. Historical Background
- B. Definition of Euthanasia and Physician-Assisted Suicide
- 1. Euthanasia
- 2. Assisted Suicide
- C. Criteria of Due Care
- D. Advance Directive Requesting Euthanasia
- E. Request for Euthanasia by a Minor Patient
- F. Notification to the Municipal Forensic Pathologist
- G. The Regional Euthanasia Review Committees
- 1. Establishment and Composition
- 2. Duties and Responsibilities
- 3. Psychiatric Patients
- 4. 'Tired of Life'
- H. The End-of-Life Clinic
- II. Withholding or Withdrawing (Cessation) of Treatment
- III. Termination of Treatment at the Request of the Patient
- IV. Pain Relief with Life-Shortening Effects
- V. Palliative (Terminal) Sedation
- VI. (Not-Physician) Assisted Suicide
- Chapter 3. Specific Activities
- §1. Termination of Pregnancy (Abortion)
- I. Short Overview of the Existing Legal Rules on Termination of Pregnancy
- II. Termination of Pregnancy by a Physician
- III. Late Termination of Pregnancy
- IV. Registration of Termination of Pregnancy by Physicians
- V. Wrongful Life
- §2. Sterilisation
- I. Surgical Sterilisation
- II. Sterilisation of Mentally Handicapped
- §3. Medically Assisted Procreation
- I. General Legal Framework
- II. Donation of Gametes for Procreation
- III. Donation of Embryos for Procreation
- IV. Right to Know the Identity of the Donor of Gametes
- V. Surrogacy
- §4. Human Genetics
- I. Genetic Testing and Insurances
- II. Clinical Genetics
- §5. Removal and Transplantation of Organs
- I. The Scope of the Organ Donation Act
- II. Removal of Organs from Living Donors
- A. General Conditions
- B. Adult Living Donors
- C. Minor Living Donors
- III. Removal of Organs after Death
- A. Persons Competent to Give Consent or to Object
- B. Declaration of Will and Registration of Donor Form
- C. Diagnosis of Death
- D. Notification and Allocation of Available Organs
- E. Preparatory Actions and Removal of Organs
- F. The Protocol
- G. Organ Centres
- §6. Research
- I. Research with Human Persons
- A. Research with Human Persons That Is Not a Clinical Trial on Medicinal Products for Human Use
- 1. General Dispositions (Paragraph 1 Medical Research Act)
- a. Definitions
- b. Positive Opinion of a Research Ethics Committee on the Research Protocol
- 2. Rules Governing Scientific Research with Subjects (Paragraph 2 Medical Research Act)
- a. General Rules
- b. Research with Minor and Incapacitated Subjects
- c. Research with Vulnerable Subjects
- d. Informed Consent
- e. Research in an Emergency Case
- f. Information Prior to Consent
- 3. Liability and Insurance (Paragraph 3 Medical Research Act)
- B. Clinical Trials on Medicinal Products for Human Usage
- 1. Field of Application of the Clinical Trials Regulation
- 2. The Protection of Subjects in Clinical Trials
- a. Prior Authorisation
- b. General Provisions for the Protection of Subjects
- i. General Principle
- ii. Proportionality Requirement (Balance Benefits-Risks)
- iii. Informed Consent
- iv. Respect for the Rights to Physical and Mental Integrity, to Privacy and to Data Protection
- v. As Little Pain, Discomfort, Fear and any Other Foreseeable Risk
- vi. Medical Care under the Responsibility of an Appropriately Qualified Medical Doctor/Dental Practitioner
- vii. No Undue Influence
- viii. Protection of Subjects During the Clinical Trial
- c. Clinical Trials on Incapacitated Subjects
- i. Incapacitated Subject
- ii. Informed Consent of the Legally Designated Representative
- iii. Respect for the Explicit Wish to Refuse or Withdraw Consent
- iv. No incentives or Financial Inducements
- v. The Clinical Trial is Essential and No Alternative
- vi. Directly Related to the Medical Condition of the Subject
- vii. A Direct Benefit for the Subject . or .
- viii. . Some Benefit for the Population Represented by the Subject and Directly Related to the Life-Threatening or Debilitating Medical Condition from Which the Subject Suffers
- ix. Ethical Assessment on the Basis of Expertise in the Relevant Disease
- d. Clinical Trials on Minors
- i. Basic Rule
- ii. Informed Consent
- iii. Information to Be Provided to the Minor
- iv. Explicit Wish to Refuse Is Respected
- v. No Incentives or Financial Inducements
- vi. A Medical Condition That Only Occurs in Minors . or .
- vii. . Essential to Validate Alternatives
- viii. Directly Related to the Medical Condition of the Minor or No Alternative but Minors
- ix. A Direct Benefit for the Minor . or .
- x. . Some Benefit for the Population Represented by the Minor
- xi. Ethical Assessment on the Basis of Paediatric Expertise
- e. Clinical Trials on Pregnant or Breastfeeding Women
- f. Clinical Trials on Other Vulnerable Subjects
- g. Clinical Trials in Emergency Situations
- II. Research with Gametes, Embryos in Vitro and Foetuses
- A. Research with Gametes
- B. Research with Embryos
- 1. Common Provisions
- a. Positive Opinion on the Research Protocol
- b. Donation of Embryos for Research
- 2. Research with Embryos Outside the Human Body Which Does Not Induce Pregnancy
- 3. Research with Embryos Outside the Human Body Which is Intended to Induce Pregnancy
- C. Research with Foetuses
- D. Prohibited Uses of Gametes and Embryos
- 1. Creation of Embryos for Research
- 2. Other Prohibited Uses of Gametes and Embryos
- 3. Prohibition to Create a Chimera or a Hybrid
- 4. Prohibition of Procedures Aimed at Gender Selection, Unless
- III. Research with Personal Data
- IV. Research with Human Bodily Material
- A. Research with Anonymous Human Bodily Material
- B. Research with Organs
- C. Research with Foetal Tissues
- V. Population Screening
- A. Definition of Population Screening
- B. Licensing Requirements
- C. Protection of Research Subjects
- Part III. The Physician and the Healthcare System
- Chapter 1. Relations with Other Healthcare Providers
- §1. Pharmacists
- I. The Practice of Pharmacy
- II. Professional Relations Between Physicians and Pharmacists
- §2. Dentists
- §3. Healthcare Psychologists
- §4. Psychotherapists
- §5. Physiotherapists
- §6. Midwives
- §7. Nursing Profession
- I. The Practice of Nursing
- II. Professional Relations Between Physicians and Nurses
- §8. Physician Assistants
- §9. Clinical Technologists
- §10. Orthopedagogics-generalist
- §11. Bachelors Medical Care Providers
- §12. Registered Dental Hygienists
- §13. Paramedical Professions
- I. Dieticians
- II. Occupational Therapists
- III. Speech Therapists
- IV. Dental Hygienists
- V. Remedial Therapists
- VI. Orthoptists
- VII. Podiatrists
- VIII. Pharmacy Assistants
- IX. Skin Therapists
- X. Clinical Physicists
- XI. Optometrists
- XII. Radiodiagnostic and Radiotherapeutic Laboratory Technicians
- XIII. Dental Prosthetists
- XIV. Carers in Individual Healthcare
- Chapter 2. Relations with Healthcare Provisions
- §1. Hospitals
- §2. Relations Between Hospitals and Physicians
- §3. Health Insurance
- Selected Bibliography
- Index
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