WMA Declaration of Kigali on the Ethical Use of Medical Technology

Adopted by the 53^rd WMA General Assembly, Washington, DC, USA, October 2002, and
revised by the 63^rd WMA General Assembly, Bangkok, Thailand, October 2012 and
by the 74^th WMA General Assembly, Kigali, Rwanda, October 2023, and
renamed “Declaration of Kigali” by the 75^th WMA General Assembly, Helsinki, Finland, October 2024

PREAMBLE

Medical technology has come to play a key role in modern medicine. It has helped provide significantly more effective means of prevention, diagnosis, treatment and rehabilitation of illness, for example through the development and use of information technology, such as telehealth, digital platforms and large-scale data collection and analyses, or the use of advanced machinery and software in areas like medical genetics and radiology, including assistive, artificial, and augmented intelligences.

The importance of technology for medical care will continue to grow and the WMA welcomes this progress. The continuous development of medical technologies – and their use in both clinical and research settings – will create enormous benefits for the medical profession, patients, and society.

However, as for all other activities in the medical profession, the use of medical technology for any purpose, must take place within the framework provided by the basic principles of medical ethics as stated in the WMA Declaration of Geneva: The Physician’s Pledge, the International Code of Medical Ethics and the Declaration of Helsinki.

Respect for human dignity and rights, patient autonomy, beneficence, confidentiality, privacy and fairness must be the key guiding points when medical technology is developed and used for medical purposes.

The rapidly developing use of big data has implications for confidentiality and privacy. Using data in ways which would damage patients’ trust in how health services handle confidential data would be counterproductive. This must be borne in mind when introducing new data driven technology. It is essential to preserve high ethical standards and achieve the right balance between protecting confidentiality and using technology to improve patient care.

Additionally, bias through for example social differences in the collection of data may skew the intended benefits of data driven medical treatment innovations.

As medical technology advances and the potential for commercial involvement grows, it is important to protect professional and clinical independence.

RECOMMENDATIONS

Beneficence

1. The use of medical technology should have as its primary goal benefit for patients’ health and well-being. Medical technology should be based on sound scientific evidence and appropriate clinical expertise. Foreseeable risks and any increase in costs should be weighed against the anticipated benefits for the individual as well as for society, and medical technology should be tested or applied only if the anticipated benefits justify the risks.

Confidentiality and privacy

2. Protecting confidentiality and respecting patient privacy are central tenets of medical ethics and must be respected in all uses of medical technology.

Patient autonomy

3. The use of medical technology must respect patient autonomy, including the right of patients to make informed decisions about their health care and control access to their personal information. Patients must be given the necessary information to evaluate the potential benefits and risks involved, including those generated by the use of medical technology.

Justice

4. To ensure informed choices and avoid bias or discrimination, the basis and impact of medical technology on medical decisions and patient outcomes should be transparent to patients and physicians. In support of fair and equitable provision of health care, the benefits of medical technology should be available to all patients and prioritized based upon clinical need and not on the ability to pay.

Human rights

5. Medical technology must never be used to violate human rights, such as use in discriminatory practices, political persecution or violation of privacy.

Professional independence

6. To guarantee professional and clinical independence, physicians must strive to maintain and update their expertise and skills, i.e., by developing the necessary proficiency with medical technology. Medical curricula for students and trainees as well as continuing education opportunities for physicians must be updated to meet these needs. Physicians shall be included in contributions to research and development. Physicians shall remain the expert during shared decision making and not be replaced by medical technology.
7. Health care institutions and the medical profession should:

• help ensure that innovative practices or technologies that are made available to physicians meet the highest standards for scientifically sound design and clinical value;
• require that physicians who adopt innovations into their practice have relevant knowledge and skills;
• provide meaningful professional oversight of innovation in patient care;
• encourage physician-innovators to collect and share information about the resources needed to implement their innovations safely, effectively, and equitably; and
• assure that medical technologies are applied and maintained appropriately in accordance with their intended purpose.

8. The relevance of these general principles is stated in detail in several existing WMA policies. Of particular importance are:

• WMA Declaration of Seoul on Professional Autonomy and Clinical Independence
• WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
• WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks
• WMA Statement on Augmented Intelligence in Medical Care
• WMA Statement on Digital Health
• WMA Statement on Cyber-Attacks on Health and Other Critical Infrastructure
• WMA Statement on Access to Health Care
• WMA Declaration of Lisbon on the Rights of the Patient
• WMA Declaration of Oslo on Social Determinants of Health

9. The WMA encourages all relevant stakeholders to embody the ethics guidance provided by these documents.