Regulatory framework that describes how to properly manage digital records so that they meet the requirements for regulatory inspection by the FDA.

Outlines FDA regulations for the protection of human subjects in clinical investigations, including requirements for informed consent. Subpart D sets forth additional safeguards to protect children involved in clinical investigations, ensuring that the risks are minimized, the benefits justify the research, and appropriate parental or guardian consent is obtained.

The level of agreement between the measured value and the true value of the clinical event or characteristic.

The U.S. Food and Drug Administration (FDA) defines the adolescent age group as ages 12 through 21 years.

When human biases are integrated into algorithms. Algorithmic bias can skew the accuracy and impact of an algorithm. Bias baked into an algorithm, whether intentionally or not, will replicate when the algorithm is used and can have the effect of amplifying human bias.

Evaluates the performance of an algorithm to convert sensor outputs into physiological metrics using a defined data capture protocol in a specific subject population.

Any interpretable measures of a physiologic process or behavioral construct in units that are not directly comparable to the digital clinical measure of interest.

A software intermediary that allows two applications to talk to each other. It can define interactions between multiple software applications or mixed hardware-software intermediaries. It defines the kinds of calls or requests that can be made, how to make them, the data formats that should be used, the conventions to follow etc.

A technical and scientific field devoted to the engineered system that generates outputs such as content, forecasts, recommendations or decisions for a given set of human-defined objectives.

A child’s affirmative agreement to participate in a clinical investigation. Assent must be sought in addition to the consent of a legally authorized representative or surrogate when the individual is sufficiently cognitively capable of understanding the nature of his or her participation in a research study.

Refers to devices, software, or systems that are designed to support, improve, or maintain the functional capabilities of children with disabilities or developmental challenges. These technologies help children manage medical conditions, enhance their ability to communicate, learn, move, or participate in daily activities, and improve their overall quality of life. Some examples of where assistive technologies are used in pediatric care include:

Communication: Speech-generating devices or apps.
Mobility: Powered wheelchairs or adaptive strollers.
Learning and Cognitive Support: Software and apps designed to enhance focus, memory, and problem-solving skills.
Health Monitoring: Wearable monitors or connected devices that track vital signs.
Sensory Assistance: Hearing aids, visual aids, or sensory integration tools.

A feature or characteristic of a medical product — such as efficacy or effectiveness, safety, means of administration, duration of effect, or duration of use — that may affect benefit-risk considerations.

A reduction in the number of participants in a clinical trial over the course of the trial.

For data generated from connected sensors, audit trails involve computer-generated date-time stamps that capture all details pertaining to the collection of clinical trial data, such as: data creation, modification and deletion.

The favorable effects of a medical product. Types of benefit include clinical benefit. May also include important characteristics of the medical product, such as convenience (e.g. dosing regimen or route of administration) that may lead to improved patient compliance, or benefits that affect those other than the patient.

Evaluation of the demonstrated benefits and risks of a medical product and making a judgment as to whether the expected benefits outweigh the potential risks associated with its expected use.

Defined characteristics that are measured as indicators of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. It may include molecular, histologic, radiographic, or physiologic characteristics. It is not a measure of how an individual feels, functions, or survives.

One or more parties of the clinical trial are kept unaware of the treatment assignment. Patients, investigators, and healthcare providers may all be blinded to the treatment a patient is receiving.

Traditionally defined as residential subscribership to high-speed Internet access, but now as daily access to the Internet:

• at speeds, quality and capacity necessary to accomplish common tasks,
• with the digital skills necessary to participate online, and
• on a personal device and secure convenient network.

Broadband equity is achieved when all people and communities are able to access and use affordable, high-speed, reliable internet that meets their long-term needs.

A relatively small portion of a total budget, often overlooked or undervalued in larger financial planning or resource allocation. Child healthcare costs are described as “budget dust” because, despite children making up a significant portion of the population, the actual spending on their care represents a small fraction of overall healthcare expenditures.

A person helping to care for a loved one who is unable to manage day-to-day life alone due to an illness. This role includes helping with daily needs, managing the household, and supervising health care.

The amalgamation of individuals involved in care for children, from family members to community-based individuals and pediatricians, and specialists.

A person who helps a patient with daily activities, health care, or any other activities that the patient is unable to perform himself/herself due to illness or disability, and who understands the patient’s health-related needs. This person may or may not have decision-making authority for the patient and is not the patient’s healthcare provider.

A statement of the relative desirability or acceptability to caregivers of attributes by which alternative health interventions may differ.

Children’s Health Insurance Program (CHIP) provides low-cost health coverage to children whose caregivers earn too much money to qualify for Medicaid. In some states, CHIP covers pregnant women.

A law that protects the online information of children under 13 years old. It applies to operators of websites and online services that target children, and requires them to obtain parental consent before collecting personal information from children. COPPA was designed to safeguard young people from potential abuse and privacy violations because children cannot legally consent to the use of their data. 

A therapeutic intervention may be said to confer clinical benefit if it prolongs life, improves function, and/or improves the way a patient feels.

Describes activities that occur between a patient and a healthcare provider.  Primary purpose historically has been to address health problems with recent shifts towards preventative care and maintaining wellness.

A measurable characteristic that describes or reflects how an individual feels, functions or survives.

Assessment of a clinical outcome can be made through report by a clinician, a patient, a non-clinician observer or through a performance-based assessment. There are four types: 

1. Patient-reported outcome (PRO), 
2. Clinician-reported outcome (ClinRO) measures,
3. Observer-reported outcome (ObsRO), and 
4. Performance outcome (PerfO).

The extent to which an endpoint can capture and measure an aspect of a potential clinical benefit (improvement in how the patient feels, functions, and/or survives) that is important from a clinical perspective and from the patient’s perspective.

Describes activities that occur during a study or investigation. Primary purpose is to develop a better understanding of factors influencing health and illness in people; Clinical trials for drug development are a subset of clinical research.

Change in a subject’s clinical condition regarded as important whether or not due to the test intervention.

An investigation or research that involves one or more human subjects, undertaken to assess/evaluate the safety or effectiveness of a medical device.

The conclusion that a given use of a medical product will lead to a net improvement in health outcome or provide useful information about diagnosis, treatment, management, or prevention of a disease.

Evaluates whether the physiological metric acceptably identifies, measures, or predicts a meaningful clinical, biological, physical, functional state, or experience, in the stated context of use and specified population.

A measurement based on a report that comes from a trained healthcare professional after observation of a patient’s health condition. Most ClinRO measures involve a clinical judgment or interpretation of the observable signs, behaviors, or other manifestations related to a disease or condition. ClinRO measures cannot directly assess symptoms that are known only to the patient (e.g., pain intensity).

A measurement based on a report that comes from a trained healthcare professional after observation of a patient’s health condition. Most ClinRO measures involve a clinical judgment or interpretation of the observable signs, behaviors, or other manifestations related to a disease or condition. ClinRO measures cannot directly assess symptoms that are known only to the patient (e.g., pain intensity).

A fixed amount paid by the patient, on top of their deductible, for a covered health care service.

Codes billed in conjunction with a procedure code to provide more specific information beyond the code description (e.g., rendered via audio or video).

Product composed of any combination of a drug and device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product. An example would include continuous glucose monitoring (CGM). 

In a regulatory context, it is the measurable aspect of an individual’s clinical, biological, physical, or functional state, or experience that the assessment is intended to capture (or reflect). 

Implanted medical devices, digitally connected to transmit regular data (i.e. insulin pumps).

A statement that fully and clearly describes how the medical product development tool is to be used and the purpose of the use.

Outlines the process, rules of engagement, and expectations for security researchers (or others) who find and report potential security issues, in good faith.

Understanding and facility with meeting culturally unique needs across all patients.

Numerical codes used to identify medical services and procedures provided by qualified healthcare professionals. Codes that are reimbursable can be billed to insurers.

Numerical codes used to identify medical services and procedures provided by qualified healthcare professionals. Codes that are reimbursable can be billed to insurers.

A roadmap for how the data will be organized and analyzed and how results will be presented. It should be established when planning a research study (i.e., before data collection begins).

Translates business needs into data and system requirements and seeks to manage data and its flow through the enterprise.

Application of processes including filling in the missing values, smoothing noisy data, analyzing and removing outliers, and removing inconsistencies in the data to clean datasets for analysis and application. 

Individuals and organizations that rely upon sensor data to drive their objectives and decision-making. Includes: clinicians, researchers, healthcare administrators, payers and health technology assessment (HTA) bodies, regulators, and public health agencies.

The technical and business processes used to (aggregate and) combine data from multiple sources to provide a unified, single view of the data.

A written document that describes the data you expect to acquire or generate during the course of your research study; how you intend to manage, describe, analyze, and store said data; and what mechanisms you will use at the end of your study to preserve and share your data.

An independent committee that may be established by the sponsor to assess, at intervals, the progress of a clinical investigation, the safety data, or the critical performance endpoints and make recommendations to the sponsor whether to continue, modify, or stop an investigation.

The set of rules, regulations, practices, and/or processes that ensure only authorized individuals and organizations see patient data & medical information.

Any operation or set of operations which are performed on sensor data (and it’s accompanying data) such as collection, recording, organization, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.

Individuals and organizations that collect, record, organize, structure, store, adapt, alter, retrieve, consult, transmit, make available, align, combine, manage, restrict, erase, or destruct sensor data. Include analytics companies, cloud service providers, data aggregators, data platforms, data scientists, and data engineers.

Individuals and organizations participating in the generation of sensor data for use in clinical decision-making in healthcare and research. Include connected sensor technology manufacturers and digital measurement companies in addition to people authorized to enter, document, change, or transmit sensor data.

The practice of protecting digital health data from unauthorized access,  corruption, or theft throughout its entire lifecycle.

A study that moves some or all of the trial participant interventions and prospective data collection outside of the traditional clinical trial sites and into the real world. These studies may use electronic platforms and data sources, mobile health providers or ship investigational products directly to patients.

The amount a patient pays for covered health care services before their insurance plan starts to pay.

Objective measure that emerges when a physiologic process or behavioral construct depends on the technology used to capture it to such an extent that it sets the medical definition for that process or construct.

Objective, quantifiable, physiological, and behavioral data collected using digital devices to measure health information from patients. These devices can be portable, wearable, implantable, or ingestible, and can collect data continuously.

Health outcome or physiological characteristic of an individual’s health, wellness, and/or condition that are collected digitally with a sensor.

The gap between those who have affordable access, skills, and support to effectively engage online and those who do not. It prevents equal participation and opportunity in all parts of life, disproportionately affecting people of color, Indigenous peoples, households with low incomes, people with disabilities, people in rural areas, and older adults.

A precisely defined variable intended to reflect an outcome of interest that is 1) collected digitally with a sensor, and 2) statistically analyzed to address a particular research question.

Condition in which all individuals  and communities have the information technology capacity needed for full participation in our society, democracy and economy.

Use of technology and electronic communications tools, services and processes to deliver healthcare services or to  facilitate better health. Incorporates a broad array of evolving technologies including: telemedicine, remote  monitoring, AI-enabled solutions, apps, trackers and digital therapeutics.

Ability to seek, find, understand and appraise health information from electronic sources and apply the knowledge gained to addressing or solving a health problem.

Digital health measurement uses digital technologies to collect clinical and other forms of health data from individuals outside of traditional clinical settings during activities of daily living. 

Electronic tools, systems, devices and resources that generate, store and process data in health care and research, which may include mobile health, wearable devices, telehealth, telemedicine, electronic health records, and patient portals.

A combination of programs and policies that meet a geographic community’s unique and diverse needs. Coordinating entities work together in an ecosystem to address all aspects of the digital divide, including affordable broadband, devices, and skills.

Refers to activities necessary to ensure all individuals and communities have access to and use of Information and Communication Technologies (ICTs).  This includes 5 elements:

1) affordable, robust broadband internet service;

2) internet-enabled devices that meet the needs of the user;

3) access to digital literacy training;

4) quality technical support; and

5) applications and online content designed to enable and encourage self-sufficiency, participation and collaboration.

Must evolve as technology advances and requires intentional strategies and investments to reduce and eliminate historical, institutional and structural barriers to access and use technology.

Digital therapeutics and connected implantables (e.g. an insulin pump).

The ability to use information and communication technologies (ICTs) to find, evaluate, create, and communicate information, requiring both cognitive and technical skills.

Technology products that process data captured by mobile sensors using algorithms to generate measures of behavioral and/or physiological function. AKA ‘connected sensor technology’. Include digital biomarkers, e-clinical outcome assessments and digital tools that measure adherence and safety.

The sensor, algorithms, data science platforms and person/patient data platforms that are required for remote monitoring.

Describes a field, concerned with the use of digital technologies as tools for measurement, and intervention in the service of human health.

A mobility outcome quantified from a wearable device (inertial measurement unit – IMU), using algorithms to extract specific mobility features of interest.

Trusted guides who assist community members in internet adoption and the use of computing devices. Services include ongoing assistance with affordable internet access, device acquisition, technical skills, and application support.

Technology products that capture data using mobile sensors, then process these data using algorithms to generate measures of behavioral and/or physiological function.

Any personal data collected digitally. This could include medical records, sensor data, race, education level, social media post, and bill payments that may or may not be covered by HIPAA.

Evidence-based therapeutic interventions delivered through software programs to prevent, manage, or treat medical conditions. Typically used independently or alongside medications, devices, or other therapies. Can offer personalized and accessible healthcare solutions. Key characteristics include their ability to deliver measurable clinical outcomes and their integration with clinical practice to support patient care.

Describes products that consumers use to measure characteristics that might influence their personal well-being, such as physical activity and sleep.

The Digital Medicine Society is the professional society for the digital medicine community. Together, we drive scientific progress and broad acceptance of digital medicine to enhance public health.

Units considered directly comparable are either identical, or can be translated for the purposes of comparison, such as via calibration.

The direct and indirect impacts of a patient’s health condition that has a negative effect on health, functioning, and overall well-being. The impacts include (but are not limited to): the physical and physiologic of the disease and its symptoms; co-morbidities; emotional and psychological; social; patient’s ability to care for self and others; time and financial; on the patient’s family.

In the field of healthcare: Wholesale drug retailers and pharmacies.

An FDA program that manages the Drug Development Tool (DDT) qualification process under section 507 of the Federal Food, Drug, and Cosmetic (FD&C) Act. It guides stakeholders in the development and refinement of DDTs (e.g., biomarkers, clinical outcome assessments) determined to aid drug development and regulatory review.

An enduring database that is electronically protected from alterations and is maintained until the end of the record retention period.

A COA describes or reflects how an individual feels, functions, or survives; When a COA is collected using sensor technology, it is called an electronic outcome assessment or ‘eCOA’.

EHRs contain individual health records for patients and are used in care delivery. Generally maintained by health care providers, health care organizations, and health care institutions and are used to deliver care. Can be used to integrate real-time electronic health care information from medical devices and multiple health care providers involved in care of patients.

The legal contract between the vendor who developed the connected sensor technology and the end user, often where the product has been purchased by the user from an intermediary such as a retailer or provided by a trial sponsor.

A EULA specifies in detail the rights and restrictions which apply to the use of the software.

Events or outcomes that can be measured objectively to determine whether the intervention being studied is beneficial.

The process of registering or entering a patient into a clinical trial. Once a patient has been enrolled, the participant would then follow the clinical trial protocol. Clinical investigations are designed to enroll a set number of participants to increase the likelihood of answering the trial questions.

A U.S. law that replaced the No Child Left Behind Act. It aims to improve educational equity by addressing achievement gaps, requiring states to develop plans for supporting underperforming schools, and setting goals for academic success. It mandates annual testing, public reporting on school performance, and stakeholder involvement, including input from parents and communities.

A framework that aims to ensure new digital health technologies are clinically effective and offer value to the health and care system. It guides developers through how to generate high-quality evidence.

A U.S. federal law that safeguards the privacy of student education records. It grants parents specific rights concerning their children’s records, which transfer to students when they turn 18 or attend a postsecondary institution. These rights include the ability to access, request amendments to, and control disclosure of their education records.

The number of calendar days between the date a 510(k) submission is received and the date of an Medical Device User Fee Amendment (MDUFA) [Substantially Equivalent/Not Substantially Equivalent] Decision, excluding the days the submission was on hold for an Additional Information (AI) request.

Federally funded nonprofit health centers or clinics that serve medically underserved areas and populations. FQHCs provide primary care services regardless of your ability to pay. Services are provided on a sliding scale fee based on your ability to pay.

The traditional healthcare reimbursement model. Under FFS, healthcare providers are paid for each service they deliver. This includes doctor’s visits, procedures, tests, and use of digital health products. 

In the context of use of a Digital Health Technology (DHT) in a clinical investigation, a conclusion that the level of validation associated with a DHT is sufficient to support its context of use.

A list of prescription drugs covered by a prescription drug plan or another insurance plan offering prescription drug benefits. Also called a drug list.

The Federal Joint Committee (G-BA) is a public legal entity comprising the four leading umbrella organizations of the self-governing German healthcare system: the National Associations of Statutory Health Insurance Physicians and Dentists, the German Hospital Federation, and the Central Federal Association of Health Insurance Funds.

A commercial off-the-shelf computing platform, with or without wireless connectivity, that may be handheld or otherwise portable in nature (e.g., mobile phone, tablet, or smart watch). May also be described as a mobile platform.

The extent to which study findings can be reliably extended to the target population of interest.

An independent public authority (API) in France tasked to improve the quality of patient care and to guarantee equity within the healthcare system.

Under HIPAA, a provider of medical or health services and any other person or organization who furnishes, bills, or is paid for healthcare in the normal course of business.

A particular type of health difference that is closely linked with social or economic disadvantage. They adversely affect groups of people who have systematically experienced greater social or economic obstacles to health based on their racial or ethnic group, religion, socioeconomic status, gender, mental health, cognitive, sensory, or physical disability, sexual orientation, geographic location, or other characteristics historically linked to discrimination or exclusion.

The study of the allocation of resources within the health economy to optimize productivity and outcomes.

Health economics focuses on measuring and valuing the outcomes of healthcare interventions.
Outcomes research comprises a set of scientific disciplines that evaluate the effect of healthcare interventions on patients.
HEOR is the confluence of 2 fields that work together to provide powerful data and insights for healthcare decision makers.

Health equity means that everyone has a fair and just opportunity to be as healthy as possible. This requires removing obstacles to health such as poverty, discrimination, and their consequences, including powerlessness and lack of access to good jobs with fair pay, quality education and housing, safe environments, and health care.

The unfair and avoidable differences in health status seen within and between populations.

Companies that contract individual people to pay some or all of their health care costs in exchange for a premium.

An Act of Congress that outlines the lawful use and disclosure of protected health information (PHI) in the United States. HIPAA compliance is regulated by the Department of Health and Human Services (HHS) and enforced by the Office for Civil Rights (OCR).

The degree to which individuals have the capacity to obtain, process and understand basic health information needed to make appropriate health decisions. It also includes numeracy skills — such as calculating cholesterol and measuring medication doses —and knowledge of health topics.

An individual who receives coverage of their healthcare expenses by a third-party payer.

Regional and national HTA bodies provide recommendations on medicines and other health technologies that can be financed or reimbursed by the healthcare system in a particular European Union (EU) Member State or region.

An individual’s or a group’s perceived physical and mental health over time.

A bill that health care providers submit for reimbursement that use specific codes to indicate vital information about the patient interaction including demographics, diagnoses, and procedures performed.

Translating the patient journey into uniform codes that tell the full patient journey and indicate what services were performed for reimbursement or reporting purposes.

Alphanumeric procedure codes used to identify specific healthcare procedures, services, supplies, and equipment. The HCPCS system consists of two levels of codes: 

1. Level I, which includes the Current Procedural Terminology (CPT) codes developed by the American Medical Association (AMA), and
2. Level II, which comprises a broader range of codes for items such as durable medical equipment, drugs (e.g., chemotherapy drugs under J-codes), and supplies.

A set of performance measures for health plans developed by the National Committee for Quality Assurance (NCQA) that provides purchasers with information on effectiveness of care, plan finances and costs, and other measures of plan performance and quality.

Data strong enough to support conclusions and interpretations equivalent to those derived from error-free data.

The application of knowledge about human behavior, abilities, limitations, and other characteristics of users to the design and development of sensor-based digital health technologies to optimize usability within a defined intended use or context of use.

An approach to interactive systems that aims to make systems usable and useful by focusing on the users, their needs and requirements, and by applying human factors and usability knowledge and techniques.

A testable statement regarding the topic under investigation’s safety or performance (effectiveness) that is used to design the clinical trial and that can be accepted or rejected based on the results of the clinical trial and statistical calculations.

The medical or other guidelines that determines whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. The criteria are not used to reject people personally, but to identify appropriate participants for the trial and keep them safe. Also known as Eligibility or Enrollment Criteria.

A general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.

Process that requires a potential trial participant be given all of the information needed to make a sound decision about whether to volunteer to willingly participate. For informed consent to be meaningful, participants need to be “tech-literate” enough to understand the specifics of how their data will be obtained and used, or they need to be appropriately supported to understand these specifics.

A request for reimbursement of healthcare service and drug costs sent by either a patient or a distributor to an insurance company.

Processes and documents which outline a strategy to connect labeling concepts (i.e. the claims associated with a new drug) to the evidence-generating trials and studies in the drug program.

The specific clinical circumstance or purpose for which a medical product or test is being developed. In the regulatory context, “intended use” refers to the objective intent of the persons legally responsible for the labeling of medical products.

Events that occur after treatment initiation that affect either the interpretation or the existence of the measurements associated with the clinical question of interest.

Codes that are used to classify and code diagnoses and diseases and provide a standardized language for healthcare providers to document and report patient conditions.

A network of smart technologies attached to and/or inside human bodies.

An amalgamation of medical devices and applications that can connect to healthcare information technology systems using networking technologies.

A network of smart technologies attached to and/or inside things.

The ability of different information systems, devices and applications to access, exchange, integrate and use data in a coordinated manner, within and across organizational, regional and national boundaries, to provide timely and seamless portability of information and optimize the health of individuals and populations globally.

The diagnostic or therapeutic device, biologic, and/or drug under investigation in a clinical trial that is believed to have an effect on outcomes of interest in a study.

A person responsible for the conduct of the clinical trial at the trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the Principal Investigator (PI).

Heavily regulated, non-profit insurers who are legally required to accept all applicants and are permitted to sell health insurance in Germany. 

All text, tables, and figures in labeling as described in regulations for a specific product.

Ensuring that information in or related to a digital health product is presented in a language in which the individual is fluent

The minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.

Individual who is authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.

The price a drug manufacturer initially sets for a given drug.

The act of concluding participation, prior to completion of all protocol-required elements, in a trial by an enrolled subject.

A subset of AI and is defined as the process of optimizing model parameters through computational techniques, such that the model’s behavior reflects the data or experience.

A medical device that uses machine learning, in part or in whole, to achieve its intended medical purpose.

Manage Medicaid administration on behalf of state governments. MCOs are key drivers of innovation within Medicaid, expanding the use of alternative value-based or risk-based payment models that create incentives for high value care to supplement traditional fee-for-service contracting.

A healthcare-specific administrative and management entity that provides select core functions for a healthcare offering

Relies on the measurement, observation, or perception of a physiological process or behavioral construct by a trained healthcare professional, with or without equipment or technology; for instance, manual respiratory rate counting through visual inspection or auscultation.

Aspect of a disease that a patient (a) does not want to become worse, or (b) wants to improve, or (c) wants to prevent

noun

Health outcomes, or measurable characteristics of an individual’s health and/or condition

verb

The process to create a digital clinical measure is a “digital measurement process”

A public health insurance program for some people or families with limited incomes and resources, including children, pregnant women, older adults, and people with disabilities. People who receive Medicaid have most or all of their health care services paid for by U.S. federal, state, and local governments. Each state government runs its own Medicaid program using federal guidelines, so Medicaid rules and benefits can differ from state to state. To be eligible for Medicaid, a person or family must meet the Medicaid rules of the state in which they live.

A regulatory term describing an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease

The Medical Device Development Tool (MDDT) Program is a Center for Devices and Radiological Health (CDRH) program to identify, facilitate, and qualify tools to assess the effectiveness, safety, or performance of a medical device.

A report submitted to the FDA by a manufacturer, a physician, or a patient about a marketed device that may have caused or contributed to a death or serious injury. A report can be submitted at the following link: https://www.fda.gov/medicaldevices/safety/reportaproblem/default.htm 

The MDUFA establishes fees that companies must pay in order to have their products evaluated by the FDA. An “MDUFA Decision” refers to the designation of Substantially Equivalent or Not Substantially Equivalent rendered through the 510(k) Program.

U.S. federal health insurance program for people who are 65ᐩ, certain younger people with disabilities, and people with End-Stage Renal Disease. Different parts help cover specific services. 

The part of the U.S. federal health insurance program that provides Hospital Insurance. It covers inpatient hospital stays, care in a skilled nursing facility, hospice care, and some home health care.

The part of the U.S. federal health insurance program that covers Medical Insurance. It covers certain doctors’ services, outpatient care, medical supplies, and preventive services.

The part of the U.S. federal health insurance program that covers prescription drug coverage It helps cover the cost of prescription drugs (including many recommended shots or vaccines).

Assurance that the methods and processes used to obtain and analyze patient experience data are rigorous, robust, and adhere to scientifically established principles and best practices for method development or implementation. Evidence generated in this way increases confidence that the results can be trusted, interpreted, and support the intended regulatory uses.

The smallest change in an outcome that a patient would perceive as clinically meaningful.

Research that uses both qualitative and quantitative research methods. See qualitative and quantitative research methods.

A clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one investigator.

An executive non-departmental public body of the Department of Health and Social Care in England whose role is to improve outcomes for people using the NHS and other public health and social care services.

A device which fails to meet the criteria for substantial equivalence (see below) to the chosen predicate device. Any device receiving an NSE determination may not be legally marketed in the US until the device is determined to be SE or the device undergoes the PMA or De Novo process.

A reference measure specifically designed for an analytical validation study. Novel comparators can be categorized as manual or reported measures.

A novel measure captures an outcome that has never previously been assessed, either by a digital or non-digital tool. 

It is possible to digitize the measurement of an existing outcome, but this would not be a novel measure.

Not all digital measures are novel.

A measurement based on a report by a non-expert third party of how a person feels or functions in daily life.

A measurement based on a report of observable signs, events or behaviors related to a patient’s health condition by someone other than that patient or a health professional. Generally a parent, caregiver, or someone who observes the patient in daily life. They are particularly useful for patients who cannot report for themselves (e.g., infants or individuals who are cognitively impaired). It does not include medical judgement or interpretation.

Any individual with or at risk of a specific health condition, whether or not he or she currently receives any therapy to prevent or treat that condition. Patients are the individuals who directly experience the benefits and harms associated with medical products.

An individual or group of individuals, who may or may not be part of the target patient population, who has a role in promoting an interest or cause to influence policy with respect to patients’ health or healthcare.

An approach that prioritizes the needs, preferences and values of patients, engaging them as active partners and decision makers in their own care. In the context of clinical trials, centralizing the patient (or participant) experience helps to:

• Guide the selection of meaningful outcomes, 
• Reduce burden on patients and caregivers by improving trial efficiency,
• Ensure appropriate privacy and data rights are protected throughout all stages of their development.

Activities that involve patient stakeholders sharing their experiences, perspectives, needs, and priorities that help inform FDA’s public health mission. Such activities may include (but are not limited to): testimony at Advisory Committee meetings, submission to regulations.gov public docket; meetings attended by patients, FDA, and other stakeholders; other correspondence with FDA; interactions through social media; and interactions with or information from patient representatives or patient advocates.

A forum for the voice of patients and will be asked to advise on complex issues related to medical devices and their impact on patients. The goal of PEAC is to better understand and integrate patient perspectives into oversight, to improve communications with patients about benefits, risks, and clinical outcomes related to medical devices, and to identify new approaches, unforeseen risks or barriers, and unintended consequences from the use of medical devices.

Includes data that are collected by any persons and are intended to provide information about patients’ experiences with a disease or condition. It can be interpreted as being related (but not limited) to: 1) the symptoms of their condition and its natural history; 2) the impact of the conditions on their functioning and quality of life; 3) their experience with treatments; 4) input on which outcomes are important to them; 5) patient preferences for outcomes and treatments; and 6) the relative importance of any issue as defined by patients.

Information that captures patients’ experiences, perspectives, needs, and priorities. See Patient Experience Data.

An individual patient, caregiver or patient advocacy group that engages other stakeholders to ensure the patients’ wants, needs and preferences are represented in activities related to medical product development and evaluation.

A type of patient experience data that specifically relates to patients’ attitudes or points of view about their condition or its management. Patient perspectives may include (but are not limited to): perceptions, goals, priorities, concerns, opinions, and preferences.

Assessments of the relative desirability or acceptability to patients of specified alternatives or choices among outcomes or other attributes that differ among alternative health interventions. The methods for generating PPI may be qualitative, quantitative, or mixed methods.

An individual, who may or may not be part of the target population, who has direct experience with a disease or condition (e.g., a patient or caregiver) and can provide information about a patient’s experience with the disease or condition.

An outcome that is important to patients’ survival, functioning, or feelings as identified or affirmed by patients themselves, or judged to be in patients’ best interest by providers and/or caregivers when patients cannot report for themselves.

Ensuring that patients’ experiences, perspectives, needs, and priorities are meaningfully incorporated into decisions and activities related to their health and well-being.

A systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into the development and evaluation of medical products throughout the medical product life cycle.

Patient experience data or other information that comes directly from patients.

Self-assessment of how a person feels or functions in daily life, reported without modification of interpretation. Can be measured by self-report or by interview. Unobservable symptoms known only to the patient (e.g., pain severity or nausea) can only be measured by PRO measures. 

The person, organization, or entity that sets service rates, collects payment, processes claims, and pays claims associated with healthcare services administered by a provider. Most often refers to private insurance companies that provide their customers with health plans that offer cost coverage, and reimbursements for medical treatment and care services

Pediatric patients as defined by the Center for Devices and Radiological Health (CDRH) are individuals who are younger than 22 years.

• Neonates: from birth → first 28 days of life
• Infants: 29 days to 2 years
• Children: 3 years to 5 and 6 to 11
• Adolescents: 12 through 21 (up to but not including the 22nd birthday)

An approach to design, strengthen and evaluate routine health information systems (RHIS). Puts emphasis on the organizational, technical and behavioural determinants of RHIS performance. Encourages and guides the development of interventions for strengthening or reforming RHIS.

A measurement based on standardized task(s) performed by a patient that is administered and evaluated by an appropriately trained individual or is independently completed. They require patient cooperation and motivation and include measures such as gait speed, memory recall or other cognitive testing.

All individually identifiable health information that is used, maintained, stored, or transmitted by a HIPAA-covered entity or a business associate of a HIPAA-covered entity, in any form or media whether electronic, paper, or oral. 

A commercial business licensed to research, develop, market and/or distribute drugs, most commonly in the context of healthcare.

All the steps that must be taken to ensure medications are available and accessible to patients. A wide range of stakeholders are also involved in the pharmaceutical supply chain, including manufacturers, wholesale distributors, and pharmacy benefit managers (PBM).

Intermediaries in the process by which the price paid for a drug is determined. Work for insurance companies, large employers and government agencies.

Codes that indicate the specific location where a healthcare service was provided.

All additional submissions to a PMA or PMA supplement before approval of the PMA or PMA supplement, or all additional correspondence after PMA or PMA supplement approval.

The submission required for a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA.

Data flowing from the digital sensing product. This data may have been through some electrical filters and firmware filtering before being transmitted.

A formal written request for feedback from FDA to help guide product development and/or application preparation.

The level of agreement between measured quantity values obtained by replicate measurements on the same or similar objects under specified conditions.

The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Regulatory obligations set by regulatory bodies like the FDA that must be fulfilled before a product can be introduced to the market. These requirements ensure that digital health products like medical apps, wearable devices, and software intended for medical use, are safe and effective for their intended purpose. 

Premarket requirements may include:

• Pre-market Submission: Manufacturers must submit their digital health technology for regulatory review. This could be in the form of a 510(k) submission, De Novo request, or premarket approval (PMA) application, depending on the device classification.
• Clinical Data: Evidence from clinical studies demonstrating the safety and effectiveness of the technology may be required, particularly for high-risk devices.
• Quality Management System: Companies must have a quality management system (QMS) in place that complies with regulations such as the FDA’s Quality System Regulation (QSR). This ensures that the product is designed, developed, and manufactured consistently and meets quality standards.

Labeling Requirements: Clear instructions and labeling that accurately describe the product, its intended use, and any associated risks must be provided.

A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease that is: prescribed by a doctor; bought at a pharmacy; prescribed for and intended to be used by one person; and regulated by FDA through the New Drug Application (NDA) process.

Measures the physiologic process or behavioral construct of interest directly; for instance, transmissive photoplethysmography (PPG) when used for deriving oxygen saturation (SpO₂).

Approval from a health plan that may be required before a person gets a service or fills a prescription in order for the service or prescription to be paid for or covered by a health plan

Codes that represent specific medical procedures and services provided to patients and help in identifying and categorizing healthcare procedures for various purposes, including billing, reimbursement, and statistical analysis.

Data that has gone through operations such as collection, recording, organization, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction. These operations include the following steps and may happen at multiple points in the data lifecycle, all of which must be known and documented:

• Data cleaning and compression
• Algorithmic transformation to generate clinically interpretable data and information.

Proof of training or capability in a specific area of expertise required for the performance of care duties. For example, a person who is a Qualified Healthcare Professional under the Social Security Act would have to have the requisite licenses or certifications, but there may be professional licenses or certifications of other professionals that are appropriate

A type of corporate entity for which the shareholders must hold a professional license in the business in which they plan to operate. In many states, PCs are the only type of corporate entity that are allowed to engage in business to provide those professional services. Certain states also limit ownership of a PC to licensed members of that profession

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. A protocol amendment is a written description of a change(s) to or a formal change of a protocol.

Americans are entitled, by law, to a notice period of any proposed federal regulation. They are also entitled to provide feedback on that proposed rulemaking, in a process known as “public comment.” The agencies must review all public comments and respond in the final regulation—failure to do so can and has been used to successfully challenge final rules in court

The science and art of preventing disease, prolonging life, and promoting health through the organized efforts and informed choices of society, organizations, public and private communities, and individuals.

The overall program through which interested parties may request feedback from the FDA in writing or during a meeting regarding potential or planned medical device submissions (relevant pathways: Investigational Device Exemption (IDE) applications, PMA applications, De Novo requests, 510(k) submissions, Clinical Laboratory Improvement Amendments (CLIA) Waivers, Duals, Accessory Classifications Requests, Investigational New Drug (IND) applications, and Biologics License Applications (BLAs)).

Individual who is qualified by education, training, licensure/regulation (when applicable) and facility privileging (when applicable) who performs a professional service within their scope of practice and independently reports that professional service.

Methods associated with the gathering, analysis, interpretation, and presentation of narrative information (e.g., spoken or written accounts of experiences, observations, and events). May also include direct observations (e.g., non-verbal communication and behaviors).

A practice used in healthcare payment models where a portion of the payment to a healthcare provider is withheld until certain quality measures are met. This practice is often seen in value-based care arrangements, where the incentive is for providers to achieve specific quality benchmarks in patient care.

A measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. 

Methods associated with the gathering, analysis, interpretation, and presentation of numerical information.

The process of assigning trial subjects to investigational treatment or control groups (may use a comparator) using an element of chance to determine the assignments in order to reduce bias.

Data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. RWD can come from a number of sources.

Clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated by different study designs or analyses, including but not limited to: randomized trials including large simple trials, pragmatic trials, and observational studies prospective and/or retrospective.

Settings outside of traditional clinical trials environments.

Active efforts by investigators to identify subjects who may be suitable for enrollment into a clinical trial. Subjects are selected on the basis of the protocol’s inclusion and exclusion criteria during the clinical trial recruitment period.

The number of subjects that must be recruited for enrollment into a study and meet the requirements of the protocol.

A measure in which the performance of a sensor-based digital health technology algorithm is assessed during analytical validation.

Collection of data from locations that are distant from the investigator or trial personnel.

A technology-based system of enabling monitoring of patients and/or participants outside of conventional clinical settings, such as in the home and during activities of daily living. 

A patient-reported reference measure is based on a report that comes directly from a patient about the status of their health condition, while an observer-reported reference measure is based on a report from another individual based on observable signs, events, or behaviors related to a patient’s health condition.

The individual, group of individuals, or entity providing patient experience data. They may be patients, parents, sexual/romantic partners, caregivers, physicians, or other healthcare professionals. Appropriate selection will depend on the definition of the target patient population of interest. If a patient can be reasonably expected to reliably self-report, then one would expect them to be the reporter in that research study.

Confidence that a sample from which evidence is generated is sufficiently similar to the intended population. In the context of patient experience data, representativeness includes the extent to which the elicited experiences, perspectives, needs, and priorities of the sample are sufficiently similar to those of the intended patient population.

A document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. It guides the study and associated data collection and analysis in a productive and standardized manner.

Activities by the clinical trial team to encourage and support a subject to remain enrolled and participate in the clinical trial.

The benefits gained from an investment in healthcare services, treatments, or technologies relative to the costs incurred. ROI measures the efficiency and value of these investments, often considering both economic returns (e.g., cost savings, revenue generation) and health outcomes (e.g., improved patient care, reduced hospitalizations).

The administrative and clinical functions that contribute to the capture, management, and collection of revenue from patient account creation to receipt of payment for service.

Adverse events and other unfavorable effects associated with a medical product. They include drug interactions, risks identified in non-clinical data, risks to those other than the patient (e.g. those preparing and administering the medical product), and risks based on pharmacologic class or current knowledge of the product. Factors such as potential misuse, abuse, or diversion of the product may also be considered.

The degree to which a patient would accept increased probability or severity of a harm in exchange for a specific expected benefit.

The contractually agreed upon timeframe during which a V1C solution may be obligated to continue to provide services after contract termination to ensure continuity of care

Relative freedom from harm. In clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests and procedures, psychiatric evaluation, and/or physical examination of subjects.

Methods and approaches of systematically obtaining, analyzing, and using information that captures patients’ experiences, perspectives, needs, and priorities in support of the development and evaluation of medical products.

A process of active evaluation of potential participants for enrollment in a trial. After a patient is recruited, screening occurs during the enrollment period to see if they meet the inclusion and exclusion criteria. If they meet the criteria, the subject is eligible to enroll in the trial.

Performs ethical style of hacking on mission critical networks and report vulnerabilities by following policies of coordinated disclosure; also known as white hat hackers.