Archives: Glossary

A record in which identifying information is removed. Under the HIPAA Privacy Rule, data are de-identified if either: an experienced expert determines that the risk that certain information could be used to identify an individual is “very small” and documents and justifies the determination, or the data do not include any of the 18 identifiers (of the individual or his/her relatives, household members, or employers) which could be used alone or in combination with other information to identify the subject. Note that even if these identifiers are removed, the Privacy Rule states that information will be considered identifiable if the covered entity knows that the identity of the person may still be determined. – UCSB IRB

A “designated record set” are records maintained by or for a covered entity and consist of:
Medical records and billing records about individuals;
Enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for an insurance provider; or
Other records that are used by or for the covered entity to make decisions about individuals. – HHS

Diabetic retinopathy is a diabetes complication that affects eyes. It’s caused by damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina). – Mayo Clinic

The failure to (a) establish an accurate and timely explanation of the patient’s health problem(s) or (b) communicate that explanation to the patient. – Society to Improve Diagnosis in Medicine

Dynamic consent (DC) is an approach to consent that enables people, through an interactive digital interface, to make granular decisions about their ongoing participation. This approach has been explored within biomedical research, in fields such as biobanking and genomics, where ongoing contact is required with participants. Journal of Empirical Research on Human Research Ethics

An electronic health record (EHR) is a digital version of a patient’s paper chart. EHRs are real-time, patient-centered records that make information available instantly and securely to authorized users. – HealthIT.gov

Data encryption helps prevent unauthorized users from reading data on a cluster and associated data storage systems. This includes data saved to persistent media, known as data at rest, and data that may be intercepted as it travels the network, known as data in transit. – AWS Documentation

FDA has issued a series of guidance documents to help provide wider access to certain products like face masks for the public and medical-grade devices for healthcare professionals. These guidances use discretion for some FDA requirements, such as waving compliance with certain regulatory requirements such as 510(k)s, registration and listing, and quality system regulation requirements.  – FDAImports

Genetics is a term that refers to the study of genes and their roles in passing of certain traits or conditions from one generation to another. Genetics involves scientific studies of genes and their effects. – NIH

A measurable DNA and/or RNA characteristic that is an indicator of normal biologic processes, pathogenic processes, and/or response to therapeutic or other interventions. – FDA