mHealth Glossary

Accessory— A device that is distributed separately but intended to be attached to or used in conjunction with another 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

Body Area Network (BAN)— A network of sensors that are placed on a patient’s body which transmit information wirelessly and have the ability to monitor physiological parameters, perform diagnostic functions or perform therapeutic functions. http://www.fcc.gov/document/medical-body-area-networks-first-report-and-order

Clinical Decision Support (CDS)—“A process for enhancing health-related decisions and actions with pertinent, organized clinical knowledge and patient information to improve health and healthcare delivery.” http://www.himss.org/asp/topics_clinicalDecision.asp

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

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/

Draft Guidance—Pursuant to the Food and Drug Administration Modernization Act of 1997, when the FDA begins the process of creating new regulations they must release a draft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

Federal Communications Commission (FCC)—The FCC is an independent government agency that is overseen by Congress, and serves to regulate all communication via radio, television ,wire, satellite and cable in the United States.  The current Chairman of the FCC is Julius Genachowski, who was appointed by President Barrack Obama. http://www.fcc.gov/what-we-do

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 (health IT or HIT)—Encompasses a broad range of functions that technology plays within healthcare, and includes devices that create, store or transmit electronic health data.  The Obama administration has promoted health IT as a solution for cutting costs and improving quality of care in our healthcare system. http://www.medpac.gov/publications%5Ccongressional_reports%5CJune04_ch7.pdf

Health Insurance Portability and Accountability Act (HIPAA)—1996 legislation, sponsored by Sen. Nancy Kassebaum (R-KS), that led to HHS’ implementation of the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) which sets privacy standards for individual’s health information. http://www.hhs.gov/ocr/privacy/

Health Information Technology for Economic and Clinical Health Act (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 mHealth regulation, the classification in question is whether a device’s intended use is as a medical device, or not. http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm

 Laboratory Information Management System (LIMS) or Laboratory Information System Software (LIS)—A LIMS or LIS is a comprehensive software based system which provides a centralized and organized location for all medical laboratory data.  They support modern laboratory operations, including: workflow and data tracking support, flexible architecture, and smart data exchange interfaces, for use in regulated environments. http://www.gliquality.org/sites/default/files/L2_templates/2.7_WHO%20Computerized%20LIMS_v1.pdf

 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

Remote Monitoring — The use of wireless communications devices in conjunction with monitoring hardware to track a patient’s condition while they are in their homes.  Doctors can use the data collected through remote monitoring to identify a patient’s worsening condition without requiring the patient to stay in a hospital. http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__remote_monitoring/1222

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

Section 618 of the Food and Drug Administration Safety and Innovation Act—Requires the FDA, ONC and FCC to post the FDA’s draft recommendations on their website to elicit comments.  Also stipulates that when creating new regulations, the Secretary of HHS should convene a working group to obtain the perspectives of all stakeholders.
http://www.amia.org/news-and-publications/public-policy-news/fda-safety-and-innovation-act-2012-and-health-information-t

Software Modularization—The identification of software modules or components that are portable or can be used across many devices, so that such portable modules be subject to less stringent regulations. http://mhealthregulatorycoalition.org/wp-content/uploads/2010/06/MRC-Comments-on-FDA-Draft-MMA-Guidance.pdf

Wellness—A category of healthcare that encompasses diet and exercise, and involves improving health based on lifestyle changes rather than medication or medical procedures.  For MRC’s purposes, the distinction between wellness and health is extremely important because they potentially fall under different regulatory boundaries.
http://www.nationalwellness.org/index.php?id_tier=2&id_c=26


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