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Direct care is the care of an identified patient by an identified clinical professional, used throughout the National Health Service in the United Kingdom.
In late 2023, it became the focus of the first public uses of the NHS purchase of Palantir software.,,,,
The Second Caldicott Report, chaired by Dame Fiona Caldicott, defined direct care as:
A clinical, social or public health activity concerned with the prevention, investigation and treatment of illness and the alleviation of suffering of an identified individual. It includes supporting individuals’ ability to function and improve their participation in life and society. It includes the assurance of safe and high quality care and treatment through local audit (identified patient safety), the management of untoward or adverse incidents.
There is no consensus on whether the definition should include measures of person satisfaction including measurement of outcomes undertaken by one or more registered and regulated health or social care professionals and their team with whom the individual has a legitimate relationship for their care. Such considerations may come under individual audit mechanisms, however healthcare systems may seek wider access for the purposes of their bureaucracy.
Direct Care is contrasted with Secondary Uses, which are all other uses of medical records, usually as bulk personal datasets, some of which have been the source of international controversy. Examples of secondary uses include health care analytics, risk stratification, medical research, and pharmaceutical marketing. Uses of health care records without patient consent are controversial. [2]
In nursing, direct care of a patient is provided personally by a staff member. Direct patient care may involve any aspects of the health care of a patient, including treatments, counselling, self-care, patient education and administration of medication. [3]
In the second report for the Department of Health, Fiona Caldicott wrote that:
The use of personal confidential data for local clinical audit is permissible within an organisation with the participation of a health and social care professional with a legitimate relationship to the patient through implied consent. For audit across organisations, the use of personal confidential data is permissible... where approved."
Confidentiality involves a set of rules or a promise usually executed through confidentiality agreements that limits the access or places restrictions on certain types of information.
Medical privacy, or health privacy, is the practice of maintaining the security and confidentiality of patient records. It involves both the conversational discretion of health care providers and the security of medical records. The terms can also refer to the physical privacy of patients from other patients and providers while in a medical facility, and to modesty in medical settings. Modern concerns include the degree of disclosure to insurance companies, employers, and other third parties. The advent of electronic medical records (EMR) and patient care management systems (PCMS) have raised new concerns about privacy, balanced with efforts to reduce duplication of services and medical errors.
The Health Insurance Portability and Accountability Act of 1996 is a United States Act of Congress enacted by the 104th United States Congress and signed into law by President Bill Clinton on August 21, 1996. It modernized the flow of healthcare information, stipulated how personally identifiable information maintained by the healthcare and healthcare insurance industries should be protected from fraud and theft, and addressed some limitations on healthcare insurance coverage. It generally prohibits healthcare providers and healthcare businesses, called covered entities, from disclosing protected information to anyone other than a patient and the patient's authorized representatives without their consent. With limited exceptions, it does not restrict patients from receiving information about themselves. It does not prohibit patients from voluntarily sharing their health information however they choose, nor does it require confidentiality where a patient discloses medical information to family members, friends, or other individuals not a part of a covered entity.
Human subject research is systematic, scientific investigation that can be either interventional or observational and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups.
The terms medical record, health record and medical chart are used somewhat interchangeably to describe the systematic documentation of a single patient's medical history and care across time within one particular health care provider's jurisdiction. A medical record includes a variety of types of "notes" entered over time by healthcare professionals, recording observations and administration of drugs and therapies, orders for the administration of drugs and therapies, test results, X-rays, reports, etc. The maintenance of complete and accurate medical records is a requirement of health care providers and is generally enforced as a licensing or certification prerequisite.
Clinical audit is a process that has been defined as a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change
Pseudonymization is a data management and de-identification procedure by which personally identifiable information fields within a data record are replaced by one or more artificial identifiers, or pseudonyms. A single pseudonym for each replaced field or collection of replaced fields makes the data record less identifiable while remaining suitable for data analysis and data processing.
Dame Fiona Caldicott, was a British psychiatrist and psychotherapist who also served as Principal of Somerville College, Oxford She was the National Data Guardian for Health and Social Care in England until her death.
The Caldicott Committee's December 1997 Report on the Review of Patient-Identifiable Information, usually referred to as the Caldicott Report, identified weaknesses in the way parts of NHS handled confidential patient data. The report made several recommendations, one of which was the appointment of Caldicott guardians, members of staff with a responsibility to ensure patient data is kept secure:
Recommendation 3: A senior person should be nominated in each NHS organisation, including the Department of Health and associated agencies, to act as a "guardian". The "guardian" should normally be a senior health professional or be closely supported by such a person. The NHS IM&T Security Manual requires each organisation to designate a senior medical officer to oversee all procedures affecting access to person-identifiable health data. This role and that of the "guardian" may be combined, providing there is no conflict of interest. The Department of Health should take the development of this role forward in partnership with interested parties.
The Caldicott Committee's Report on the Review of Patient-Identifiable Information, usually referred to as the Caldicott Report was a review commissioned in 1997 by the Chief Medical Officer of England due to increasing worries concerning the use of patient information in the National Health Service (NHS) in England and Wales and the need to avoid the undermining of confidentiality because of the development of information technology in the NHS, and its ability to propagate information concerning patients in a rapid and extensive way.
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).
A glossary of terms used in clinical research.
The Patient Safety and Quality Improvement Act of 2005 (PSQIA): Pub. L.Tooltip Public Law 109–41 (text)(PDF), 42 U.S.C. ch. 6A subch. VII part C, established a system of patient safety organizations and a national patient safety database. To encourage reporting and broad discussion of adverse events, near misses, and dangerous conditions, it also established privilege and confidentiality protections for Patient Safety Work Product. The PSQIA was introduced by Sen. Jim Jeffords [I-VT]. It passed in the Senate July 21, 2005 by unanimous consent, and passed the House of Representatives on July 27, 2005, with 428 Ayes, 3 Nays, and 2 Present/Not Voting.
Privacy for research participants is a concept in research ethics which states that a person in human subject research has a right to privacy when participating in research. Some typical scenarios this would apply to include, or example, a surveyor doing social research conducts an interview with a participant, or a medical researcher in a clinical trial asks for a blood sample from a participant to see if there is a relationship between something which can be measured in blood and a person's health. In both cases, the ideal outcome is that any participant can join the study and neither the researcher nor the study design nor the publication of the study results would ever identify any participant in the study. Thus, the privacy rights of these individuals can be preserved.
The National Information Governance Board for Health and Social Care (NIGB) advised the United Kingdom government on information governance between 2008 and 2013.
Transgender hormone therapy, also called hormone replacement therapy (HRT) or gender-affirming hormone therapy (GAHT), is a form of hormone therapy in which sex hormones and other hormonal medications are administered to transgender or gender nonconforming individuals for the purpose of more closely aligning their secondary sexual characteristics with their gender identity. This form of hormone therapy is given as one of two types, based on whether the goal of treatment is masculinization or feminization:
In Electronic Health Records (EHR’s) data masking, or controlled access, is the process of concealing patient health data from certain healthcare providers. Patients have the right to request the masking of their personal information, making it inaccessible to any physician, or a particular physician, unless a specific reason is provided. Data masking is also performed by healthcare agencies to restrict the amount of information that can be accessed by external bodies such as researchers, health insurance agencies and unauthorised individuals. It is a method used to protect patients’ sensitive information so that privacy and confidentiality are less of a concern. Techniques used to alter information within a patient’s EHR include data encryption, obfuscation, hashing, exclusion and perturbation.
Privacy in education refers to the broad area of ideologies, practices, and legislation that involve the privacy rights of individuals in the education system. Concepts that are commonly associated with privacy in education include the expectation of privacy, the Family Educational Rights and Privacy Act (FERPA), the Fourth Amendment, and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Most privacy in education concerns relate to the protection of student data and the privacy of medical records. Many scholars are engaging in an academic discussion that covers the scope of students’ privacy rights, from student in K-12 and even higher education, and the management of student data in an age of rapid access and dissemination of information.
The National Data Guardian for Health and Social Care is an independent, non-regulatory, advice giving body in England sponsored by the Department of Health and Social Care. Dame Fiona Caldicott had held the position on a non-statutory basis since its inception in November 2014. She was appointed the first statutory National Data Guardian in March 2019 following the introduction of the Health and Social Care Act 2018, and remained in post until her death in February 2021. Dr Nicola Byrne was appointed to the role in March 2021 by the Secretary of State for Health and Social Care.
A significant event audit (SEA), also known as significant event analysis, is a method of formally assessing significant events, particularly in primary care in the UK, with a view to improving patient care and services. To be effective, the SEA frequently seeks contributions from all members of the healthcare team and involves a subsequent discussion to answer why the occurrence happened and what lessons can be learned. Events triggering a SEA can be diverse, include both adverse and critical events, as well as good practice. It is most frequently required for appraisal, revalidation and continuing professional development.