Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare purposes. BME is also traditionally logical sciences to advance health care treatment, including diagnosis, monitoring, and therapy. Also included under the scope of a biomedical engineer is the management of current medical equipment in hospitals while adhering to relevant industry standards. This involves procurement, routine testing, preventive maintenance, and making equipment recommendations, a role also known as a Biomedical Equipment Technician (BMET) or as clinical engineering.
Health Canada is the department of the Government of Canada responsible for national health policy. The department itself is also responsible for numerous federal health-related agencies, including the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC), among others. These organizations help to ensure compliance with federal law in a variety of healthcare, agricultural, and pharmaceutical activities. This responsibility also involves extensive collaboration with various other federal- and provincial-level organizations in order to ensure the safety of food, health, and pharmaceutical products—including the regulation of health research and pharmaceutical manufacturing/testing facilities.
The healthcare industry is an aggregation and integration of sectors within the economic system that provides goods and services to treat patients with curative, preventive, rehabilitative, and palliative care. It includes the generation and commercialization of goods and services lending themselves to maintaining and re-establishing health. The modern healthcare industry includes three essential branches which are services, products, and finance, and may be divided into many sectors and categories and depends on the interdisciplinary teams of trained professionals and paraprofessionals to meet the health needs of individuals and populations.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
A hospital information system (HIS) is an element of health informatics that focuses mainly on the administrational needs of hospitals. In many implementations, a HIS is a comprehensive, integrated information system designed to manage all the aspects of a hospital's operation, such as medical, administrative, financial, and legal issues and the corresponding processing of services. Hospital information system is also known as hospital management software (HMS) or hospital management system.
Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals, energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries.
Integrated logistic support (ILS) is a technology in the system engineering to lower a product life cycle cost and decrease demand for logistics by the maintenance system optimization to ease the product support. Although originally developed for military purposes, it is also widely used in commercial customer service organisations.
Cold chain is defined as the series of actions and equipment applied to maintain a product within a specified low-temperature range from harvest/production to consumption. An unbroken cold chain is an uninterrupted sequence of refrigerated production, storage and distribution activities, along with associated equipment and logistics, which maintain a desired low-temperature interval to keep the safety and quality of perishable or sensitive products, such as foods and medicines. In other words, the term denotes a low temperature-controlled supply chain network used to ensure and extend the shelf life of products, e.g. fresh agricultural produce, seafood, frozen food, photographic film, chemicals, and pharmaceutical products. Such products, during transport and end-use when in transient storage, are sometimes called cool cargo. Unlike other goods or merchandise, cold chain goods are perishable and always en-route towards end use or destination, even when held temporarily in cold stores and hence commonly referred to as "cargo" during its entire logistics cycle. Adequate cold storage, in particular, can be crucial to prevent quantitative and qualitative food losses.
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs, biologics, vaccines and natural health products.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Integration verification and validation" can be abbreviated as "IV&V".
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).
Medical equipment management is a term for the professionals who manage operations, analyze and improve utilization and safety, and support servicing healthcare technology. These healthcare technology managers are, much like other healthcare professionals referred to by various specialty or organizational hierarchy names.
Although logistics has been mostly utilized in commercial supply chains, it is also an important tool in disaster relief operations. Humanitarian logistics is a branch of logistics which specializes in organizing the delivery and warehousing of supplies during natural disasters or complex emergencies to the affected area and people. However, this definition focuses only on the physical flow of goods to final destinations, and in reality, humanitarian logistics is far more complicated and includes forecasting and optimizing resources, managing inventory, and exchanging information. Thus, a good broader definition of humanitarian logistics is the process of planning, implementing and controlling the efficient, cost-effective flow and storage of goods and materials, as well as related information, from the point of origin to the point of consumption for the purpose of alleviating the suffering of vulnerable people.
Health information technology (HIT) is health technology, particularly information technology, applied to health and health care. It supports health information management across computerized systems and the secure exchange of health information between consumers, providers, payers, and quality monitors. Based on a 2008 report on a small series of studies conducted at four sites that provide ambulatory care – three U.S. medical centers and one in the Netherlands, the use of electronic health records (EHRs) was viewed as the most promising tool for improving the overall quality, safety and efficiency of the health delivery system.
Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist. It is an instance of the wider phenomenon of telemedicine, as implemented in the field of pharmacy. Telepharmacy services include drug therapy monitoring, patient counseling, prior authorization and refill authorization for prescription drugs, and monitoring of formulary compliance with the aid of teleconferencing or videoconferencing. Remote dispensing of medications by automated packaging and labeling systems can also be thought of as an instance of telepharmacy. Telepharmacy services can be delivered at retail pharmacy sites or through hospitals, nursing homes, or other medical care facilities.
Health care analytics is the health care analysis activities that can be undertaken as a result of data collected from four areas within healthcare; claims and cost data, pharmaceutical and research and development (R&D) data, clinical data, and patient behavior and sentiment data (patient behaviors and preferences,. Health care analytics is a growing industry in the United States, expected to grow to more than $31 billion by 2022. The industry focuses on the areas of clinical analysis, financial analysis, supply chain analysis, as well as marketing, fraud and HR analysis.
The medical–industrial complex is a network of interactions between pharmaceutical corporations, health care personnel, and medical conglomerates to supply health care-related products and services for a profit. The term is a product of the military–industrial complex and builds from the basis of that concept.
Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals classified as high-cost, high complexity and/or high touch. Specialty drugs are often biologics—"drugs derived from living cells" that are injectable or infused. They are used to treat complex or rare chronic conditions such as cancer, rheumatoid arthritis, hemophilia, H.I.V. psoriasis, inflammatory bowel disease and hepatitis C. In 1990 there were 10 specialty drugs on the market, around five years later nearly 30, by 2008 200, and by 2015 300.
Federal Service for Surveillance in Healthcare (Roszdravnadzor) is the federal service of the Russian Federation that exercises control and supervision functions in the field of health care. Until 2012, it was called the Federal Service for Surveillance of Health and Social Development and was subordinate to the Ministry of Health and Social Development of the Russian Federation, then from 2012 to 2020 it was shifted to reporting directly to the Government of the Russian Federation, and from 2020 again made subordinate to the Ministry of Health of the Russian Federation.
