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21 Code of Federal Regulations (CFR) Part 11

/21 kəʊd ɒv ˈfɛdərəl ˌrɛɡjʊˈleɪʃᵊnz (siː-ɛf-ɑː) pɑːt 11/

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

Accuracy

/ˈækjərəsi/

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

Algorithmic Bias

/ˌalɡəˈriT͟Hmik ˈbīəs/

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.

Analytical Validation

/ˌanəˈlidik(ə)l valəˈdāSH(ə)n/

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

Application Programming Interface (API)

/aplɪˈkeɪʃ(ə)n ˈprəʊˌɡræmɪŋ ˌɪntə(r)ˈfeɪs/

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.

Artificial Intelligence / Machine Learning (AI / ML)

/eɪ-aɪ / ɛm-ɛl/

Artificial Intelligence and Machine Learning (AI/ML) are human-like capabilities of mathematical algorithms processed by computers. It refers to software applications that, using advanced statistical methodologies, can learn patterns and derive insights from seemingly complex datasets.

Assent

/əˈsɛnt/

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.

Attribute

/ˈætrɪbjuːt/

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.

Attrition

/əˈtrɪʃən/

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

Audit Trails

/ˈôdət trāl/

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.

Benefit

/ˈbɛnɪfɪt/

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.

Benefit-risk assessment

/ˈbɛnɪfɪt-rɪsk əˈsɛsmənt/

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.

Biomarkers

/ˈbīōˌmärkər/

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.

Biometric Monitoring Technologies (BioMeTs)

/Biometric ˈmɒnɪtərɪŋ tɛkˈnɒləʤiz (BioMeTs)/

Connected digital medicine products that process data captured by mobile sensors using algorithms to generate measures of behavioral and/or physiological function, also referred to as sensor-based digital health technologies. 

Blinding / Masking

/ˈblaɪndɪŋ / ˈmæskɪŋ/

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.

Broadband Adoption

/ˈbrɔdˌbænd əˈdɑpʃən/

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

/ˈbrɔdˌbænd ˈɛkwəti/

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.

Care Partner

/kɛr ˈpɑrtnər/

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.

Caregiver

/ˈkeəˌgɪvə/

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.

Caregiver preference

/ˈkeəˌgɪvə ˈprɛfərəns/

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

Clinical Benefit

/ˈklɪnəkəl ˈbɛnəfɪt/

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

Clinical Care

/ˈklinək(ə)l ker/

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.

Clinical Outcome

/ˈklinək(ə)l outˌkəm/

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

Clinical Outcomes Assessment (COA)

/ˈklinək(ə)l ˈoutˌkəm əˈsesmənt/

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).

Clinical Relevance

/ˈklɪnɪkəl ˈrɛlɪvəns/

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.

Clinical Research

/ˈklinək(ə)l  ˈrēˌsərCH,rəˈsərCH/

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.

Clinical Significance

/ˈklɪnəkəl səgˈnɪfɪkəns/

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

Clinical Trial / Investigation / Study

/ˈklɪnəkəl ˈtraɪəl / ɪnˌvɛstəˈgeɪʃən / ˈstʌdi/

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

Clinical Utility

/ˈklinək(ə)l  ju(ː)ˈtɪlɪti/

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.

Clinical Validation

/ˈklinək(ə)l ˌvaləˈdāSH(ə)n/

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.

Clinician-reported outcome (ClinRO)

/klɪˈnɪʃən-rɪˈpɔːtɪd ˈaʊtkʌm (klin r ō)/

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).

Co-pay

/kəʊ-peɪ/

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

Code Modifier

/kəʊd ˈmɒdɪfaɪə/

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

Combination Products

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). 

Concept of Interest (COI)

/ˈkänˌsept əv ˈint(ə)rəst/

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). 

Connected Implantables

/kəˈnektəd ˌimˈplan(t)əb(ə)l/

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

Context of Use

/ˈkɑntɛkst ʌv juz/

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

Coordinated Vulnerability Disclosure (CVD) Policy

/kōˈôrd(ə)nət ˌvʌlnəɹəˈbɪlɪti disˈklōZHər ˈpäləsē/

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

Cultural Competencies

/ˈkəlCH(ə)rəl ‘kämpədəns/

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

Current Procedural Terminology (CPT®) codes

/ˈkərənt prəˈsējərəl ˌtərməˈnäləjē kōd/

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

Data analysis plan

/ˈdeɪtə əˈnæləsɪs plæn/

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).

Data architecture

/ˈdeɪtə ˈɑːkɪtɛkʧə/

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

Data cleaning

/ˈdeɪtə ˈkliːnɪŋ/

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

Data consumers

/ˈdeɪtə kənˈsjuːməz/

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.

Data integration

/ˈdeɪtə ˌɪntɪˈgreɪʃən/

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

Data management plan (DMP)

/ˈdeɪtə ˈmænɪʤmənt plæn (diː-ɛm-piː)/

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.

Data Monitoring Committee (DMC)

/ˈdeɪtə ˈmɑnətərɪŋ kəˈmɪti (di-ɛm-si)/

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.

Data privacy

/ˈdeɪtə ˈprɪvəsi/

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

Data processing

/ˈdeɪtə ˈprəʊsɛsɪŋ/

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.

Data processors

/ˈdeɪtə ˈprəʊsɛsəz/

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.

Data producers

/ˈdeɪtə prəˈdjuːsəz/

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.

Data Rights

/ˈdādə rīts/

The rights of individuals and organisations to access and control certain data. In Europe, the rights of individuals over data about them are set out in the GDPR. These are not absolute rights and the needs of individuals (including privacy), organisations and society at large need to be balanced. 

Data security

/ˈdeɪtə sɪˈkjʊərɪti/

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

Decentralized Study / Trial

/dēˈsentrəˌlīzd ˈstədē / ˈtrī(ə)l/

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.

Deductible

/dɪˈdʌktɪbl/

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

Digital Clinical Measure

/ˈdijidlˈ klinək(ə)l ˈmeZHər/

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

 

Digital Divide

/ˈdɪʤətəl dɪˈvaɪd/

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.

Digital Endpoint

/ˈdɪʤətəl ˈɛndˌpɔɪnt/

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.

Source: NIH, See also: Digital Clinical Measure

Digital Equity

/ˈdɪʤətəl ˈɛkwəti/

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

Digital Health

/ˈdɪʤətəl hɛlθ/

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.

Digital Health Literacy

/ˈdɪʤətəl hɛlθ ˈlɪtərəsi/

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 Measurements

/ˈdijidlˈ helTH meZHərmənt/

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

Digital Health Technologies

/ˈdɪʤətəl hɛlθ tɛkˈnɑləʤiz/

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

Digital Inclusion Ecosystem

/ˈdɪʤətəl ɪnˈkluʒən ˈikoʊˌsɪstəm/

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.

Digital Inclusions

/ˈdɪʤətəl ɪnˈkluʒən/

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 Intervention Products

/dijidl in(t)ərˈven(t)SH(ə)n prädəkt/

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

Digital Literacy

/ˈdɪʤətəl ˈlɪtərəsi/

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

Digital Measurement Products

/ˈdijidl ˈmeZHərmənt ˈprädəkt/

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.

Digital Measurement System

/ˈdɪʤɪtl ˈmɛʒəmənt ˈsɪstɪm/

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

Digital Medicine

/ˈdijidl ˈmedəsən/

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

Digital Mobility Outcomes (DMOs)

/ˈdɪʤɪtl məʊˈbɪlɪti ˈaʊtkʌmz (diː-ɛm-əʊz)/

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

Digital Navigators

/ˈdɪʤətəl ˈnævəˌgeɪtərz/

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.

Digital Sensing Product

/ˈdɪʤɪtl ˈsɛnsɪŋ ˈprɒdʌkt/

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

Digital Specimens

/ˈdijidl ˈspesəmən/

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.

Digital Wellness Products

/ˈdɪʤɪtl ˈwɛlnəs ˈprɒdʌkts/

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

DiMe

/dīm/

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.

Disease burden

/dɪˈziːz ˈbɜːdn/

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.

Distributors

/dɪsˈtrɪbjʊtəz/

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

Drug Development Tool (DDT) Qualification Program

/ˌdiˌdiˈti ˌkwɑləfəˈkeɪʃən ˈproʊˌgræm/

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.

Durable electronic data repository

/ˈdʊrəbəl ɪˌlɛkˈtrɑnɪk ˈdeɪtə riˈpɑzəˌtɔri/

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

Electronic Clinical Outcomes Assessment (eCOA)

/ˈklinək(ə)l ˈoutˌkəm əˈsesmənt/

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’.

Electronic Health Record (EHR)

/əˌlekˈtränik helTH ˈrekərd/

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.

End User License Agreement (EULA)

/end ˈyo͞ozər ˈlīs(ə)ns əˈɡrēmənt/

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.

Endpoint

/ˈen(d)point/

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

Enrollment

/ɛnˈroʊlmənt/

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.

Fit-for-purpose

/fɪt-fɔr-ˈpɜrpəs/

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.

Formative evaluation

/ ˈfɔrmətɪv ɪˌvæljuˈeɪʃən/

A research study or activity undertaken to evaluate usability of a prototype product, with the goals of understanding user interactions with the product and gathering information to inform design modifications.

Formulary

/Formulary/

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

Gemeinsamer Bundesausschuss (G-BA)

/ɡəˈmaɪ̯nzaːmɐ Bundesausschuss (G-BA)/

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.

General-purpose Computing Platform

/ˈʤɛnərəl-ˈpɜrpəs kəmˈpjutɪŋ ˈplætˌfɔrm/

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.

Generalizability

/ˌʤɛnərəlaɪzəˈbɪlɪti/

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

Haute Autorité de Santé (HAS)

/ot‿ ɔtɔʁite də sɑ̃te/

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

Health Care Provider (HCP)

/hɛlθ kɛr prəˈvaɪdər (eɪʧ-si-pi)/

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.

Health Disparity

/hɛlθ dɪˈspɛrəti/

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.

Health Economics

/hɛlθ ˌiːkəˈnɒmɪks/

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

Health Equity

/hɛlθ ˈɛkwəti/

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.

Health Inequities

/hɛlθ ɪˈnɛkwətiz/

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

Health Insurance companies

/hɛlθ ɪnˈʃʊərəns ˈkʌmpəniz/

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

Health Literacy

/hɛlθ ˈlɪtərəsi/

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.

Health Plan Member

/hɛlθ plæn ˈmɛmbər/

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

Health technology assessment (HTA) bodies

/hɛlθ tɛkˈnɒləʤi əˈsɛsmənt (eɪʧ-tiː-eɪ) ˈbɒdiz/

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.

Health-Related Quality of Life (HRQoL)

/hɛlθ-rɪˈleɪtɪd ˈkwɒlɪti ɒv laɪf (HRQoL)/

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

Healthcare Claim

/ˈhɛlθkeə kleɪm/

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.

Healthcare Coding

/ˈhɛlθkeə ˈkəʊdɪŋ/

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

Healthcare Common Procedure Coding System (HCPCS) Codes

/ˈhɛlθkeə ˈkɒmən prəˈsiːʤə ˈkəʊdɪŋ ˈsɪstəm (eɪʧ-siː-piː-siː-ɛs) kəʊdz/

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.

High quality data

/haɪ ˈkwɒlɪti ˈdeɪtə/

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

Human Factors

/ˈhjuːmən ˈfæktəz/

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.

Human-Centered Design

/ˈhjuːmən-ˈsɛntəd dɪˈzaɪn/

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.

Hypothesis

/haɪˈpɑθəsəs/

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.

Inclusion / Exclusion Criteria

/ɪnˈkluʒən / ɪkˈskluʒən kraɪˈtɪriə/

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.

Indication for Use (IFU)

/ˌɪndəˈkeɪʃən fɔr juz (aɪ-ɛf-ju)/

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.

Informed Consent

/inˈfôrmd kənˈsent/

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.

Insurance Claim

/ɪnˈʃʊərəns kleɪm/

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

Integrated Evidence Plan (IEP)

/ˈɪntɪgreɪtɪd ˈɛvɪdəns plæn (aɪ-iː-piː)/

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.

Intended Use

/ɪnˈtɛndɪd juːz/

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.

Intercurrent Events

/ˌɪntərˈkɜrənt ɪˈvɛnts/

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

International Classification of Diseases (ICD) Codes

/ˌɪntəˈnæʃᵊnᵊl ˌklæsɪfɪˈkeɪʃᵊn ɒv dɪˈziːzɪz (aɪ-siː-diː) kəʊdz/

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.

Internet of Bodies (IoB)

/in(t)ərˌnet əv ˈbädē/

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

Internet of Medical Things

/in(t)ərˌnet əv ˈmɛdɪkəl θɪŋz/

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

Internet of Things (IoT)

/in(t)ərˌnet əv THiNGs/

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

Interoperability

/ˌɪntərˌɒp(ə)rəˈbɪlɪti/

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.

Intervention

/ˌɪntərˈvɛnʧən/

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.

Investigator

/ɪnˈvɛstəˌgeɪtər/

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).

Krankenkassen (Sickness Funds)

/ˈkraŋkn̩kasən (ˈsɪknɪs fʌndz)/

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

Labeling

/ˈleɪbəlɪŋ/

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

Language Access

/ˈlaNGɡwij ˈakˌses/

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

Legally Authorized Representative (LAR)

/ˈligəli ˈɔθəˌraɪzd ˌrɛprəˈzɛntətɪv (lɑr)/

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

List price

/lɪst praɪs/

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

Lost to Follow Up

/lɔst tu ˈfɑloʊ ʌp/

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

Management Services Organization (MSO)

/ˈmænəʤmənt ˈsɜrvəsəz ˌɔrgənəˈzeɪʃən (ɛm-ɛs-oʊ)/

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

Meaningful Aspect of Health (MAH)

/ˈmēniNGfəl ˈaspekt əv helTH/

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

Measure

/ˈmeZHər/

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”

Medical Device

/ˈmedək(ə)l dəˈvīs/

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

Medical Device Development Tool (MDDT) Qualification Program

/ɛm-di-di-ti ˌkwɑləfəˈkeɪʃən ˈproʊˌgræm/

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.

Medical Device Report (MDR)

/ˈɛmɛdiəkeɪəɛl diɪˈvaɪɛs ɑrɪˈpiɔrt (ɛɛm-di-ɑɑr)/

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 

Medicare

/ˈmɛdɪkeə/

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. 

Medicare Part A

/ˈmɛdɪkeə pɑːt eɪ/

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.

Medicare Part B

/ˈmɛdɪkeə pɑːt biː/

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.

Medicare Part D

/ˈmɛdɪkeə pɑːt diː/

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).

Methodologically sound

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.

Minimal clinically important difference (MCID)

/ˈmɪnɪml ˈklɪnɪkəli ɪmˈpɔːtənt ˈdɪfrəns (ɛm-siː-aɪ-diː)/

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

Mixed methods research

/mɪkst ˈmɛθədz rɪˈsɜːʧ/

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

Multicenter Trial

/ˈmʌltiˌsɛntər ˈtraɪəl/

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

National Institute for Health and Care Excellence (NICE)

/ˈnæʃənl ˈɪnstɪtjuːt fɔː hɛlθ ænd keər ˈɛksələns (naɪs)/

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.

Novel Measure

/ˈnävəl ˈmeZHər/

When the outcome has not previously been measured.

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.

 

Patient

/ˈpeɪʃənt/

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.

Patient advocate

/ˈpeɪʃənt ˈædvəkɪt/

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.

Patient engagement (FDA)

/ˈpeɪʃənt ɪnˈgeɪʤmənt/

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.

Patient Engagement Advisory Committee (PEAC)

/ˈpeɪʃənt ɛnˈgeɪʤmənt ædˈvaɪzəri kəˈmɪti (pi-i-eɪ-si)/

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.

Patient experience data

/ˈpeɪʃənt ɪksˈpɪərɪəns ˈdeɪtə/

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.

Patient input

/ˈpeɪʃənt ˈɪnpʊt/

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

Patient partner

/ˈpeɪʃənt ˈpɑːtnə/

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.

 

Patient perspective

/ˈpeɪʃənt pəˈspɛktɪv/

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.

Patient Preference information (PPI)

/ˈpeɪʃənt ˈprɛfərəns ˌɪnfəˈmeɪʃən (piː-piː-aɪ)/

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.

Patient representative

/ˈpeɪʃənt ˌrɛprɪˈzɛntətɪv/

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.

Patient-centered outcome

/ˈpeɪʃənt-ˈsɛntəd ˈaʊtkʌm/

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.

Patient-focused

/ˈpeɪʃənt-ˈfəʊkəst/

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

Patient-focused drug development (PFDD)

/ˈpeɪʃənt-ˈfəʊkəst drʌg dɪˈvɛləpmənt (piː-ɛf-diː-diː)/

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-provided input

/ˈpeɪʃənt-prəˈvaɪdɪd ˈɪnpʊt/

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

Payer

/ˈpeɪər/

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

Performance outcome (PerfO)

/pərˈfɔrməns ˈaʊtˌkʌm (pərf oh)/

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.

Pharmaceutical (Pharma) company

/ˌfɑːməˈsjuːtɪkəl (Pharma) ˈkʌmpəni/

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

Pharmaceutical supply chain

/ˌfɑːməˈsjuːtɪkəl səˈplaɪ ʧeɪn/

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).

Pharmacy Benefit Managers (PBM)

/ˈfɑːməsi ˈbɛnɪfɪt ˈmænɪʤəz/

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

Place of Service Code

/pleɪs ɒv ˈsɜːvɪs kəʊd/

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

Pre-processed data

/priː-ˈprəʊsɛst ˈdeɪtə/

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

Precision

/priˈsɪʒən/

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

Prescription drugs

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.

Prior Authorization

/ˈpraɪər ˌɔθərəˈzeɪʃən/

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

Procedure Code

/prəˈsiːʤə kəʊd/

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.

Processed data

/ˈprəʊsɛst ˈdeɪtə/

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.

 

Professional Certification (or Professional License)

/prəˈfɛʃənəl ˌsɜrtəfəˈkeɪʃən (ɔr prəˈfɛʃənəl ˈlaɪsəns)/

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

Professional Corporation (PC) or Professional Association (PA)

/prəˈfɛʃənəl ˌkɔrpəˈreɪʃən (ˈpiˈsi) ɔr prəˈfɛʃənəl əˌsoʊsiˈeɪʃən (pɑ)/

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

Protocol

ˈproʊtəˌkɑl

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.

Public Comment

/ˈpəblik ˈkäment/

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

Public Health

/ˈpəblik helTH/

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.

Qualified Healthcare Professional (QHP)

/ˈkwɒlɪfaɪd ˈhɛlθkeə prəˈfɛʃᵊnᵊl (kjuː-eɪʧ-piː)/

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.

Qualitative research methods

/ˈkwɒlɪtətɪv rɪˈsɜːʧ ˈmɛθədz/

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).

Quality-adjusted life year (QALY)

/ˈkwɒlɪti-əˈʤʌstɪd laɪf jɪə (kjuː-eɪ-ɛl-waɪ)/

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

 

Quantitative research methods

/ˈkwɒntɪtətɪv rɪˈsɜːʧ ˈmɛθədz/

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

Randomization

/Randomization/

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.

Real World Data (RWD)

/rɪəl wɜːld ˈdeɪtə (ɑː-ˈdʌblju(ː)-diː)/

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.

Real World Evidence (RWE)

/rɪəl wɜːld ˈɛvɪdəns (ɑː-ˈdʌblju(ː)-iː)/

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.

Real-World Settings

ˈrē(ə)l – wərld ˈsediNG/

Settings outside of traditional clinical trials environments.

Recruitment

/rəˈkrutmənt/

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.

Remote data acquisition

/rɪˈmoʊt ˈdeɪtə ˌækwəˈzɪʃən/

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

Remote Monitoring

/rəˈmōt ˈmɒnɪtərɪŋ/

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

Reporter (Research Studies)

/rɪˈpɔːtə/

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.

 

Representativeness

/ˌrɛprɪˈzɛntətɪvnəs/

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.

Research protocol

/rɪˈsɜːʧ ˈprəʊtəkɒl/

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.

Retention

/riˈtɛnʃən/

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

Revenue Cycle

/ˈrɛvɪnjuː ˈsaɪkᵊl/

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.

Risk

/rɪsk/

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.

 

Risk tolerance

/rɪsk ˈtɒlərəns/

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

Runout Period

/Runout ˈpɪriəd/

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

Safety

/ˈseɪfti/

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.

 

Sample level data

/ˈsɑːmpl ˈlɛvl ˈdeɪtə/

A construct that holds clear and consistent meaning across all digital sensing products. The output data at the sample level (for example, a 50 Hz accelerometer signal or a 250 Hz ECG signal) from the sensor itself.

Science of patient input

/ˈsaɪəns ɒv ˈpeɪʃənt ˈɪnpʊt/

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.

Screening (of subjects)

/ˈskrinɪŋ (ʌv ˈsʌbʤɪkts)/

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.

Security Researcher

/səˈkyo͝orədē ˈrēˌsərCHər/

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

Sensor

/ˈsɛnsər/

A transducer that converts a physical, biological, or chemical parameter into an electrical signal; for example, temperature, pressure, flow, or vibration sensor. A sensor is typically hardware.

Sensor-based digital health technologies (sDHT)

/ˈsɛnsər-beɪst ˈdɪʤətəl hɛlθ tɛkˈnɑləʤiz/

Connected digital medicine products that process data captured by mobile sensors using algorithms to generate measures of behavioral and/or physiological function, also referred to as biometric monitoring technologies.

Service Level Agreement (SLA)

/ˈsɜrvəs ˈlɛvəl əˈgrimənt (ɛs-ɛl-eɪ)/

An agreement between an IT service provider and a customer. An SLA describes the IT service, documents service level targets, and specifies the responsibilities of the IT service provider and the customer. A single agreement may cover multiple IT services or multiple customers

 

Service Médical Rendu (SMR)

/ˈsɜːvɪs ɛmédical Rendu (ɛs-ɛm-ɑː)/

The benefit set by the French Haute Autorité de Santé (HAS) is a criterion which takes into account: the seriousness of the pathology for which the medicine is indicated; and the data specific to the drug itself in a given indication.

 

Software as a Medical Device (SaMD)

/ˈsɔfˌtwɛr æz ə ˈmɛdəkəl dɪˈvaɪs/

Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

Software Bill of Materials (SBOM)

/ˈsôf(t)wer bil əv məˈtirēəl/

Analogous to an ingredients list on food packaging. A nested inventory listing all the components in a given piece of software.

Standard

/ˈstandərd/

An agreed upon method for doing something that is established by industry consensus and adopted or promoted by a regulatory body

Standard of care

/ˈstændərd ʌv kɛr/

A diagnostic and treatment process that a clinician should follow for a certain type of patient, illness, or clinical circumstance.

Statistical Analysis Plan

/stəˈtɪstɪkəl əˈnæləsəs plæn/

A document detailing the methods of all planned analyses of the clinical study data.

Subgroup

/ˈsʌbgruːp/

A subset of the study population or study sample defined by specific baseline characteristics. For example, demographic subgroups are commonly defined by subject sex, race, and age.

Summative evaluation

/Summative ɪˌvæljuˈeɪʃən/

A research study undertaken on a production-equivalent or marketed product, including all components of the user interface, with the goal of demonstrating usability amongst a representative sample under conditions reflecting the intended use or context of use, referred to by the FDA as ‘human factors validation.’

Surrogate Endpoint

/ˈsərəɡə tˈen(d)point/

An endpoint that is used as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence.

System and Organization Control (SOC) Report

/ˈsɪstəm ænd ˌɔrgənəˈzeɪʃən kənˈtroʊl (ɛs-oʊ-si) rɪˈpɔrt/

These reports are intended to meet the needs of a broad range of users that need detailed information and assurance about the controls at a service organization relevant to security, availability, and processing integrity of the systems the service organization uses to process users’ data and the confidentiality and privacy of the information processed by these systems

 

Target population

/ˈtɑːgɪt ˌpɒpjʊˈleɪʃən/

The group of individuals (patients) about whom one wishes to make an inference.

 

Also referred to as the target patient population, the underlying population, or intended population.

Technology Ecosystem

/tekˈnäləjē ˈēkōˌsistəm/

The sensor, algorithms, data science platforms and person/patient data platforms that are required for successful deployment of digital medicine products.

Terms of Service (ToS)

/tərm əv ˈsərvəs/

A legal agreement between the creator of the digital technology and the user of that technology. The ToS outlines how the technology or service may or may not be used. The end user must agree to the ToS in order to use the technology.

Tiered Learning Approach

/tird ˈlərniNG əˈprōCH/

An effective learning technique that increases the intensity of instructional interventions based on need. 

Trade-off

/treɪd-ɒf/

The extent to which a change in the level of one or more attributes of a medical product that is offset by a change in one or more other attributes of that product.

Treatment burden

/ˈtriːtmənt ˈbɜːdn/

The impacts of a specific treatment or treatment regimen that have a negative effect on the patient’s health, functioning, or overall well-being. Treatment burden includes (but is not limited to): side effects, discomfort, uncertainty about treatment outcomes, dosing and route of administration, requirements, and financial impacts.

Treatment effect

/ˈtriːtmənt ɪˈfɛkt/

The amount of change in a disease/condition, symptom, or function that results from a medical intervention (as compared to not receiving the intervention or receiving a different intervention).

Treatment outcome

/ˈtriːtmənt ˈaʊtkʌm/

The benefits or harms to a patient who receives an intervention; the impact on a patient’s health, function, or well-being—or on a clinical indicator thereof—that is assumed to result from an intervention.

Treatment, Payment, and Healthcare Operations (TPO)

/ˈtritmənt, ˈpeɪmənt, ænd ˈhɛlθˌkɛr ˌɑpəˈreɪʃənz (ti-pi-oʊ)/

Defined in HIPAA Privacy Rule at 45 CFR 164.501 in order to identify the circumstances under which covered entities are allowed to disclose patient information without the need to obtain authorization from patients

Trial termination

/ˈtraɪəl tərməˈneɪʃən/

Discontinuance, by sponsor or by withdrawal of Institutional Review Board (IRB) or FDA approval, of a clinical trial before completion. This trial termination can be at a site or the entire study.

Unauthorized Surveillance

/ˌənˈôTHəˌrīzd sərˈvāləns/

When remote monitoring capabilities of an individual’s connected sensors are used for surveillance outside the scope expected by that individual. For example, by law enforcement authorities surveilling activists

Underserved Population

/əndərˈsɜrvd ˌpɑpjəˈleɪʃən/

Populations where their voices and needs are often overlooked. This population includes the economically disadvantaged, racial and ethnic minorities, the uninsured, rural residents, children and the elderly.

Unmet medical need

/Unmet ˈmɛdɪkəl niːd/

A condition whose treatment or diagnosis is not addressed adequately by available therapy. It includes an immediate need for a defined population (e.g., to treat a serious condition with no or limited treatment) or a longer-term need for society (e.g., to address the development of resistance to antibacterial drugs).

Usability

/ˌjuzəˈbɪləti/

The extent to which a product can be used to achieve specific goals with ease, efficiency, and user-satisfaction within a defined intended use or context of use.

Usability validation

/ˌjuzəˈbɪləti ˌvæləˈdeɪʃən/

Evaluation and demonstration of usability.

Use specification

/juz ˌspɛsɪfɪˈkeɪʃən/

A living document containing detailed descriptions of all user groups, all use environments, and all aspects of the product user interface

Use-related risk analysis

/juz-rɪˈleɪtɪd rɪsk əˈnæləsəs/

A living document describing reasonably foreseeable risks associated with using a product and a detailed plan to mitigate those risks. 

Utility

/yo͞oˈtilədē/

Does a digital product have the features that users need? Utility evaluates a product’s usefulness, profitability, and benefits to a specific population

Utilization Review Accreditation Commission (URAC)

/ˌjutələˈzeɪʃən ˌriˈvju əˌkrɛdəˈteɪʃən kəˈmɪʃən (ju-ɑr-eɪ-si)/

U.S. nationwide quality accrediting organization for pharmacy, health plan, digital/telehealth, mental health, patient care management, and administrative management entities

V1C Coalition by DiMe (The Virtual First Care (V1C) Coalition by the Digital Medicine Society (DiMe)

/ˈvərCH(o͞o)əl fərst ker/

The Virtual First Care (V1C) Coalition by the Digital Medicine Society (DiMe) convenes V1C leaders to accelerate effective patient care, where digital interactions are key components of a patient’s journey. Our members collaborate to build the tools, resources, and networks necessary to establish a viable omnichannel healthcare ecosystem – one that’s optimized for the digital era with a shared mission of improving outcomes, enhancing access, and meeting patients where they are with the most effective care possible.

Value based agreements (VBAs)

/ˈvælju beɪst əˈgrimənts (vi-bi-eɪz)/

A written contractual arrangement between parties in which the payment for healthcare goods and services is tied to predetermined, mutually agreed upon terms that are based on clinical circumstances, patient outcomes, and other specified measures of the appropriateness and effectiveness of the services rendered.

Verification

/ˌverəfəˈkāSH(ə)n/

The evaluation of sensor accuracy, precision, consistency, and uniformity.

Virtual First Care (V1C)

/ˈvərCH(o͞o)əl fərst ker

Virtual first care is medical care for individuals or a community accessed through digital interactions where possible, guided by a clinician, and integrated into a person’s everyday life.

21 Code of Federal Regulations (CFR) Part 11

/21 kəʊd ɒv ˈfɛdərəl ˌrɛɡjʊˈleɪʃᵊnz (siː-ɛf-ɑː) pɑːt 11/

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

Accuracy

/ˈækjərəsi/

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

Algorithmic Bias

/ˌalɡəˈriT͟Hmik ˈbīəs/

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.

Analytical Validation

/ˌanəˈlidik(ə)l valəˈdāSH(ə)n/

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

Application Programming Interface (API)

/aplɪˈkeɪʃ(ə)n ˈprəʊˌɡræmɪŋ ˌɪntə(r)ˈfeɪs/

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.

Artificial Intelligence / Machine Learning (AI / ML)

/eɪ-aɪ / ɛm-ɛl/

Artificial Intelligence and Machine Learning (AI/ML) are human-like capabilities of mathematical algorithms processed by computers. It refers to software applications that, using advanced statistical methodologies, can learn patterns and derive insights from seemingly complex datasets.

Assent

/əˈsɛnt/

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.

Attribute

/ˈætrɪbjuːt/

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.

Attrition

/əˈtrɪʃən/

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

Audit Trails

/ˈôdət trāl/

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.

Benefit

/ˈbɛnɪfɪt/

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.

Benefit-risk assessment

/ˈbɛnɪfɪt-rɪsk əˈsɛsmənt/

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.

Biomarkers

/ˈbīōˌmärkər/

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.

Biometric Monitoring Technologies (BioMeTs)

/Biometric ˈmɒnɪtərɪŋ tɛkˈnɒləʤiz (BioMeTs)/

Connected digital medicine products that process data captured by mobile sensors using algorithms to generate measures of behavioral and/or physiological function, also referred to as sensor-based digital health technologies. 

Blinding / Masking

/ˈblaɪndɪŋ / ˈmæskɪŋ/

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.

Broadband Adoption

/ˈbrɔdˌbænd əˈdɑpʃən/

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

/ˈbrɔdˌbænd ˈɛkwəti/

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.

Care Partner

/kɛr ˈpɑrtnər/

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.

Caregiver

/ˈkeəˌgɪvə/

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.

Caregiver preference

/ˈkeəˌgɪvə ˈprɛfərəns/

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

Clinical Benefit

/ˈklɪnəkəl ˈbɛnəfɪt/

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

Clinical Care

/ˈklinək(ə)l ker/

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.

Clinical Outcome

/ˈklinək(ə)l outˌkəm/

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

Clinical Outcomes Assessment (COA)

/ˈklinək(ə)l ˈoutˌkəm əˈsesmənt/

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).

Clinical Relevance

/ˈklɪnɪkəl ˈrɛlɪvəns/

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.

Clinical Research

/ˈklinək(ə)l  ˈrēˌsərCH,rəˈsərCH/

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.

Clinical Significance

/ˈklɪnəkəl səgˈnɪfɪkəns/

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

Clinical Trial / Investigation / Study

/ˈklɪnəkəl ˈtraɪəl / ɪnˌvɛstəˈgeɪʃən / ˈstʌdi/

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

Clinical Utility

/ˈklinək(ə)l  ju(ː)ˈtɪlɪti/

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.

Clinical Validation

/ˈklinək(ə)l ˌvaləˈdāSH(ə)n/

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.

Clinician-reported outcome (ClinRO)

/klɪˈnɪʃən-rɪˈpɔːtɪd ˈaʊtkʌm (klin r ō)/

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).

Co-pay

/kəʊ-peɪ/

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

Code Modifier

/kəʊd ˈmɒdɪfaɪə/

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). 

Concept of Interest (COI)

/ˈkänˌsept əv ˈint(ə)rəst/

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). 

Connected Implantables

/kəˈnektəd ˌimˈplan(t)əb(ə)l/

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

Context of Use

/ˈkɑntɛkst ʌv juz/

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

Coordinated Vulnerability Disclosure (CVD) Policy

/kōˈôrd(ə)nət ˌvʌlnəɹəˈbɪlɪti disˈklōZHər ˈpäləsē/

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

Cultural Competencies

/ˈkəlCH(ə)rəl ‘kämpədəns/

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

Current Procedural Terminology (CPT®) codes

/ˈkərənt prəˈsējərəl ˌtərməˈnäləjē kōd/

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

Data analysis plan

/ˈdeɪtə əˈnæləsɪs plæn/

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).

Data architecture

/ˈdeɪtə ˈɑːkɪtɛkʧə/

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

Data cleaning

/ˈdeɪtə ˈkliːnɪŋ/

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

Data consumers

/ˈdeɪtə kənˈsjuːməz/

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.

Data integration

/ˈdeɪtə ˌɪntɪˈgreɪʃən/

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

Data management plan (DMP)

/ˈdeɪtə ˈmænɪʤmənt plæn (diː-ɛm-piː)/

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.

Data Monitoring Committee (DMC)

/ˈdeɪtə ˈmɑnətərɪŋ kəˈmɪti (di-ɛm-si)/

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.

Data privacy

/ˈdeɪtə ˈprɪvəsi/

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

Data processing

/ˈdeɪtə ˈprəʊsɛsɪŋ/

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.

Data processors

/ˈdeɪtə ˈprəʊsɛsəz/

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.

Data producers

/ˈdeɪtə prəˈdjuːsəz/

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.

Data Rights

/ˈdādə rīts/

The rights of individuals and organisations to access and control certain data. In Europe, the rights of individuals over data about them are set out in the GDPR. These are not absolute rights and the needs of individuals (including privacy), organisations and society at large need to be balanced. 

Data security

/ˈdeɪtə sɪˈkjʊərɪti/

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

Decentralized Study / Trial

/dēˈsentrəˌlīzd ˈstədē / ˈtrī(ə)l/

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.

Deductible

/dɪˈdʌktɪbl/

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

Digital Clinical Measure

/ˈdijidlˈ klinək(ə)l ˈmeZHər/

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

 

Digital Divide

/ˈdɪʤətəl dɪˈvaɪd/

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.

Digital Endpoint

/ˈdɪʤətəl ˈɛndˌpɔɪnt/

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.

Source: NIH, See also: Digital Clinical Measure

Digital Equity

/ˈdɪʤətəl ˈɛkwəti/

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

Digital Health

/ˈdɪʤətəl hɛlθ/

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.

Digital Health Literacy

/ˈdɪʤətəl hɛlθ ˈlɪtərəsi/

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 Measurements

/ˈdijidlˈ helTH meZHərmənt/

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

Digital Health Technologies

/ˈdɪʤətəl hɛlθ tɛkˈnɑləʤiz/

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

Digital Inclusion Ecosystem

/ˈdɪʤətəl ɪnˈkluʒən ˈikoʊˌsɪstəm/

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.

Digital Inclusions

/ˈdɪʤətəl ɪnˈkluʒən/

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 Intervention Products

/dijidl in(t)ərˈven(t)SH(ə)n prädəkt/

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

Digital Literacy

/ˈdɪʤətəl ˈlɪtərəsi/

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

Digital Measurement Products

/ˈdijidl ˈmeZHərmənt ˈprädəkt/

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.

Digital Measurement System

/ˈdɪʤɪtl ˈmɛʒəmənt ˈsɪstɪm/

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

Digital Medicine

/ˈdijidl ˈmedəsən/

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

Digital Mobility Outcomes (DMOs)

/ˈdɪʤɪtl məʊˈbɪlɪti ˈaʊtkʌmz (diː-ɛm-əʊz)/

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

Digital Navigators

/ˈdɪʤətəl ˈnævəˌgeɪtərz/

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.

Digital Sensing Product

/ˈdɪʤɪtl ˈsɛnsɪŋ ˈprɒdʌkt/

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

Digital Specimens

/ˈdijidl ˈspesəmən/

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.

Digital Wellness Products

/ˈdɪʤɪtl ˈwɛlnəs ˈprɒdʌkts/

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

DiMe

/dīm/

The Digital Medicine Society is the professional society