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Often referred to as simply a medical or clinical laboratory, the medical diagnostics lab performs tests on clinical specimens in order to get information about the health of a patient as it pertains to the diagnosis, treatment, and prevention of disease. An additional definition is provided by the Clinical Laboratory Improvement Amendments (CLIA) program, as "a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings."

At a basic level, the medical laboratory, whether chemistry or pathology, operates like many other analytical testing laboratories. However, there are a few nuances between the medical laboratory and other analytical laboratories. Aside from handling human and animal specimens, one of these differences is the need to have a specific unidirectional workflow. This is intended to both minimize the risk of biohazard contamination and to establish assurance that sample cross contamination is minimized. Another major difference concerns the regulations governing the management of patient data (e.g., the Health Insurance Portability and Accountability Act [HIPAA] in the U.S. and General Data Protection Regulation [GDPR] in Europe). This creates a significant challenge not generally experienced by other types of analytical laboratories.

In most parts of the world, the medical laboratory is either attached to a hospital, performing tests on their patients, or acts as a private (or public) laboratory that receives analysis requests and samples from physicians, insurance companies, clinical research sites, and other health clinics for analysis. In cases where a particularly specialized analysis is required and a standard medical laboratory is not equipped to handle it, a research laboratory with the appropriate equipment and expertise may be employed. In other cases, a laboratory may decide it's simply more cost effective to contract more specialized, less common analyses out to specialized medical labs rather than heavily invest in the equipment and training to perform such analyses. Examples include the molecular diagnostics and cytogenetics laboratory, which provide diagnoses and treatment options for genetic or cancer-related disorders.

Like other analytical laboratories, regulations, laws, and standards typically drive how vital aspects of the laboratory operate. In the United States, clinical laboratories are primarily regulated by the Department of Health and Human Services. Inside that infrastructure are sub-entities like the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) to apply standards and regulations through their respective Laboratory Quality Assurance and Standardization Programs, and the Clinical Laboratory Improvement Amendments. Although generally not as strict as the regulations regarding pharmaceutical and diagnostic manufacturers, the regulations affecting the medical laboratory nonetheless act as a significant hurdle to managing the overall operations of the laboratory, from acquiring customers and samples, to testing, reporting results, and handling billing for the completed tests.

Internationally, regulatory bodies vary from country to country. However, organizations like the not-for-profit Clinical and Laboratory Standards Institute (CLSI) and associations like the Research Quality Association (RQA) exist to promote a more global approach to regulations and guidance affecting medical diagnostic and research laboratories. Additionally, a set of Good Clinical Laboratory Practice standards—originally developed in 2002 and since adopted by the World Health Organisation (WHO), non-governmental organizations (NGOs), and research institutions worldwide—provide guidance on implementing laboratory practices that are critical for laboratory operations around the world.