CWA 16642:2013

This CEN Workshop Agreement (CWA) describes the basic principles of quality criteria for health checks.
Quality criteria for health checks aim:
to allow clients to make informed choices about health checks,
to improve beneficence in prevention and early detection of health risks and disease,
to protect individuals against potential adverse consequences (maleficence) of health checks and
to ensure the quality of the health checks.
Although the CWA aimed for a set of generic criteria, outside the scope of the CWA are:
screening services covered by the recommendations of the Council of the EU on cancer screening,
EXAMPLE The European Union has published quality assurance guidelines for screening for breast-, colorectal and cervical cancer [1-4].
health checks, national screening programmes or other preventive and prophylactic services already regulated by national or EU legislation and rules,
EXAMPLE Prenatal screening programmes and the statutory German health check-up comply with national regulations.
products such as self-tests already covered by national or EU legislation and rules,
EXAMPLE Self-tests such as pregnancy tests are covered by Directive 98/79/EC.
indicated testing as offered within the health care system.
EXAMPLE Genetic testing for Huntington's disease is indicated when one or more family members are affected.