21 CFR Part 11
Regulatory framework that describes how to properly manage digital records so that they meet the requirements for regulatory inspection by the FDA.
Algorithmic Bias
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
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)
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.
Audit Trails
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.
Biomarkers
Defined characteristics that are measured as indicators of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.
Clinical Care
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 Assessments (COA)
An assessment of a clinical outcome (which describes or reflects how a patient feels functions or survives) made through report by a clinician, a patient, a non-clinician observer or through a performance-based assessment.
Clinical Research
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 Validation
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.
Concept of Interest (COI)
Simplified or narrowed element that can be practically measured.
Connected Sensor Product
Technology products that can be connected to the internet and capture data using mobile sensors, then process these data using algorithms to generate measures of behavioral and/or physiological function.
Context of Use
A statement that fully and clearly describes the way the medical product development tool is to be used and the regulated product development and review-related purpose of the use.
Coordinated Vulnerability Disclosure (CVD) Policy
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
Understanding and facility with meeting culturally unique needs across all patients.
Current Procedural Terminology (CPT®) codes
Numerical codes used to identify medical services and procedures provided by qualified healthcare professionals. Codes that are reimbursable can be billed to insurers.
Data Rights
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.
Decentralized Study/Trial
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.
Digital Clinical Measure
Health outcomes or physiological characteristics of an individual’s health, wellness, and/or condition that are collected digitally with a sensor.
Digital Measurement System
The sensor, algorithms, data science platforms and person/patient data platforms that are required for remote monitoring.
Digital Sensing Product
Technology products that capture data using mobile sensors, then process these data using algorithms to generate measures of behavioral and/or physiological function.
Economic Feasibility
Value from using the connected sensor product minus the cost of using the product.
End User License Agreement (EULA)
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
Event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial.
Health Economics
The study of the allocation of resources within the health economy to optimize productivity and outcomes.
Internet of Medical Things
An amalgamation of medical devices and applications that can connect to healthcare information technology systems using networking technologies.
Language Access
Quite simply: ensuring that information is presented in a language in which the patient is fluent.
Meaningful Aspect of Health (MAH)
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 (verb)
The process to create a digital clinical measure is a “digital measurement process”.
Medical Device
According to the FDA, a medical device is 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, in man, or intended to affect the structure or any function of the body of man. In the European Medical Device Regulation (MDR), a medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for specific medical purposes.
Novel Measure
When the outcome is new. Not all digital clinical measures will be novel.
Patient Engagement
A bidirectional relationship that creates mutual benefit for patients and the populations they represent, along with the clinicians, researchers, policy makers, regulators, product developers and innovators seeking patient input.
Public Health
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.
Real-World Settings
Settings outside of traditional clinical trials environments.
Remote Monitoring
A technology-based system of enabling monitoring of patients outside of conventional clinical settings, such as in the home or in a remote area. Allows for collection of data in real time in a real life setting.
Security Researcher
Performs ethical style of hacking on mission critical networks and reports vulnerabilities by following policies of coordinated disclosure; also known as white hat hacker.
Software Bill of Materials (SBOM)
Analogous to an ingredients list on food packaging: contains all the units and items in a given piece of software.
Standard
An agreed upon method for doing something that is established by industry consensus and adopted or promoted by a regulatory body.
Surrogate Endpoint
An endpoint that is used in clinical trials 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.
Terms of Service (ToS)
A legal agreement between the creator of the digital measurement 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
An effective learning technique that increases the intensity of instructional interventions based on need.
Unauthorized Surveillance
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.
Usability
How easy and pleasant the features of a digital sensing product are to use for the intended user. Usability is often considered alongside utility, and lower usability may be acceptable when utility is high.
Utility
Whether a product has the features that users need.
Verification
Evaluates sample-level sensor outputs.
Please include the following citation when you reference terms in The Playbook: Glossary, 'The Digital Clinical Measures Playbook Glossary. Last updated April 30, 2021. Available at playbook.dimesociety.org/tools/glossary.
