Glossary

Accessory— A device or software that is distributed separately but intended to be attached to or used in conjunction with a medical device, called the “parent device”. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/default.htm

Accessory Rule—According to the FDA’s current regulations, an accessory is subject to the same level of regulation as the parent device that it is designed to interact with.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm

Clinical Decision Support (CDS)—CDS software comes in many forms, and can provide patients, clinicians and physicians with a variety of functionalities including access to clinical guidelines, analysis of patient data reports, diagnostic support and access to relevant reference information.
http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__cds/1218

Clinical Knowledge-multiple sources of data that are the basis of the software analytics, including medical know-how acquired through formal professional training and experience traditionally available in text books, journals and other medical literature, including (e.g. treatment protocols, evidence based clinical practice guidelines and diagnostic criteria and methodologies) as well as general population data with health implications, patient specific information, logic and rules.

CDS Mobile Health Application—Mobile apps that allow the user to input patient-specific information and – using formulae or processing algorithms – output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263280.htm

Cloud Computing—Storing data or software in a secure online environment, where it will be accessible from any computer connected to the internet.
http://csrc.nist.gov/publications/nistpubs/800-145/SP800-145.pdf

Complete Dependence-dependency between the software and therapy  such that human intervention is minimal or non-existent.

Connected Health/Telehealth—“The use of electronic information and telecommunications technologies to support long-distance clinical healthcare, patient and professional health-related education, public health and health administration. Technologies include videoconferencing, the internet, store-and-forward imaging, streaming media, and terrestrial and wireless communications.” http://www.hrsa.gov/ruralhealth/about/telehealth/

Device Classification—To determine how strictly a medical device should be regulated, the FDA classifies the device as either “Class I,” Class II,” or “Class III.”  Class I devices present little to no risk to the patient, such as a tongue depressor or bedpan and are exempt from the premarket notification process.  Class II devices such as x-ray machines, powered wheelchairs and syringes present some potential risk and many are subject to the premarket notification process, as well as other specific safety requirements.  Class III devices present significant potential risk and usually include devices that play a role in sustaining a patient’s life: these devices, including pacemakers and automated external defibulators, are subject to the most stringent regulations.
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263280.htm

Draft Guidance—Pursuant to the Food and Drug Administration Modernization Act of 1997, when the FDA begins the process of creating new regulations they must release a first draft of these regulations to the public so that members of industry and academia can provide input, called “comments”.  After weighing and incorporating the input that they receive, the FDA issues a final guidance.
http://www.fda.gov/AboutFDA/ContactFDA/CommentonRegulations/default.htm

Electronic Health Record (EHR) — A real-time electronic record of patient health information and medical history, generated by one or by multiple visits in any care delivery setting. EHRs provide access to evidence-based decision support tools to aid clinicians in decision making. They can also support the collection of data for uses other than clinical care, such as billing, quality management, outcome reporting, and public health disease surveillance and reporting. http://healthit.hhs.gov/portal/server.pt/community/health_it_hhs_gov__glossary/1256 and http://www.himss.org/asp/topics_ehr.asp

Expert System Software – A computer system that uses a knowledge base of human expertise for problem solving. They are designed to solve complex problems by reasoning about knowledge, not by following the procedure of a developer as is the case in conventional programming. http://www.pcmag.com/encyclopedia_term/0,1237,t=expert+system&i=42865,00.asp

Food and Drug Administration (FDA)—Agency within the Department of Health and Human Services (HHS) that monitors and regulates safety standards of food, medicines, and other health products, currently headed by Margaret Hamburg, the Commissioner of Food and Drugs. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194877.htm

Health Information Technology—Encompasses a broad range of functions that technology plays within healthcare, and includes devices that create, store or transmit electronic health data.  http://www.medpac.gov/publications%5Ccongressional_reports%5CJune04_ch7.pdf

Health Information Technology for Economic and Clinical Health (HITECH)—Legislation passed in 2009, as part of President Obama’s stimulus legislation (the American Recovery and Reinvestment Act), that promotes the adoption and meaningful use of health information technology.
http://www.hhs.gov/ocr/privacy/hipaa/administrative/enforcementrule/hitechenforcementifr.html

Health App/mHealth App—Programs (“applications” or “apps”) that deliver health-related services using smartphones and tablets. Some apps offer advice and tracking functionality for healthy living. Some are designed to transmit information between doctors and patients (e.g. glucose readings for diabetes management). Some are meant for doctors to keep accurate, accessible records. http://searchhealthit.techtarget.com/definition/health-apps

Intended Use – The regulations that a product will be subjected to depends on the product’s intended use.  In the case of Clinical Decision Support software regulation, the classification in question is whether the software’s intended use qualifies it as a medical device.
http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm

Medical Device—Defined in the Federal Food, Drug and Cosmetic Act as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is. . . [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals . . . [or] intended to affect the structure or any function of the body of man or other animals.”
http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapII-sec321.pdf

Middleware—In a complex computing environment, middleware is software that allows different components such as applications and servers to interact with each other seamlessly.
http://www.middleware.org/whatis.html

Mobile Health/mHealth—The use of mobile devices such as smartphones and tablets to deliver healthcare while the patient is outside of the doctor’s office/hospital as well as in traditional healthcare settings.
http://www.hrsa.gov/healthit/mhealth.html

Office of the National Coordinator for Health Information Technology (ONC)—Organization within the Office of the Secretary of Health and Human Services that promotes the adoption of health information technology and health information exchange to improve healthcare, currently headed by Farzad Mostashari.
http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__onc/1200

Section 510(k) of the Food, Drug and Cosmetic Act—States that if a manufacturer is introducing a product into the market, they must submit a premarket notification 90 days prior to the product’s introduction.  At this point, the FDA may determine either that the product is similar enough to existing products that it does not need to undergo detailed examination or that it is truly a “new” product which must be thoroughly evaluated before it becomes available on the market.
http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm

Serious or Life Threatening Disease or Condition-(1) diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and (2) diseases or conditions with potentially fatal outcomes, where the endpoint of clinical trial analysis is survival. The seriousness of a disease is a matter of judgment, but generally is based on such factors as survival, day-to-day functioning, and the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.

Software Modularization—The practice of altering the composition of software so that it is subject to less stringent regulations.
http://mhealthregulatorycoalition.org/wp-content/uploads/2010/06/MRC-Comments-on-FDA-Draft-MMA-Guidance.pdf

Standalone Software—Software that is primarily intended to function independently from a medical device or Certified EHR Technology.  Standalone software can execute, for example, on general-purpose computers, mobile platforms (e.g., smartphones or tablets), and cloud server systems. Standalone software is not intended to reside on a medical device.
http://www.fiercehealthit.com/special-reports/fdas-approach-clinical-decision-support-software-brief-summary

Substantially Dependent- (1) there is a lack of transparency in that the user does not have sufficient time or needed knowledge to question the output of the software, (2) there is no expectation of intervention by a human with adequate knowledge and abilities to appropriately understand the output of the software, including how the output is derived, before it is used in diagnosis or treatment, or (3) there is a substantial risk of learned dependence, where overtime, the user can be expected to become so comfortable with the software that they will stop questioning it.

Vetted clinical content-clinical content that has been approved, published, or sanctioned by an appropriate source.  Appropriate source is any qualified, peer reviewed journal; a recognized medical or scientific society; government agency (e.g., the CDC); or other source that is able to adequately ensure the reliability and accuracy of the information.  Examples of vetted clinical content include the NCCN Clinical Practice Guidelines in Oncology, ACC/AHA Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices, and TNM Classification of Malignant Tumors, CDC/NCEH Key Clinical Activities for Quality Asthma Care: Recommendations from the NAEPP, NHLBI/NIH Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents and CDC/NIH/HIV Medicine Association of Infectious Diseases Society of America Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents. Vetted clinical content may include evidence-based content (e.g., government health reports) established through rigorous scientific testing, but does not include patient-specific information incorporated by a clinician.