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Fundamentals

Understanding the architecture of your own health data begins with a foundational question you may be contemplating ∞ is the information I share with my employer’s wellness program protected? The answer resides not in the wellness program itself, but in its structural relationship to your primary group health plan.

Your personal health information, a collection of biomarkers and life patterns, is a sensitive dataset. The statutes governing its privacy, chiefly the Health Insurance Portability and Accountability Act (HIPAA), operate within a defined ecosystem. The core determinant for HIPAA’s governance is whether the wellness initiative is an integrated component of your employer-sponsored group health plan.

When the program functions as a feature of this plan, perhaps influencing your premiums or cost-sharing, the data it collects is designated as Protected Health Information (PHI). This classification activates the full suite of HIPAA protections, creating a legal fortress around your data.

This structural integration is the critical point of analysis. A wellness program offered directly by an employer, existing entirely outside the framework of a group health plan, occupies a different regulatory space. In this arrangement, the health information you provide is not considered PHI under HIPAA.

This distinction is a central principle in the architecture of health data privacy. It underscores that HIPAA’s jurisdiction is precise, applying to specific entities. These are defined as “covered entities,” which include health plans, health care clearinghouses, and health care providers, along with their business associates.

An employer, in its capacity purely as an employer, does not fall into this category. Therefore, the pathway of your data determines its protection. Information that flows into a system integrated with a group health plan is shielded by HIPAA; information that flows into a standalone, employer-administered program is governed by a different set of rules, which may include other federal or state laws.

The critical factor determining HIPAA coverage for a wellness program is its integration with an employer’s group health plan.

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The Role of the Group Health Plan

The group health plan serves as the regulatory anchor for HIPAA’s application to wellness programs. When a wellness initiative is woven into the fabric of the health plan, it inherits the plan’s legal obligations. This is because the group health plan itself is a HIPAA-covered entity, tasked with the fiduciary responsibility of safeguarding member data.

Any program operating under its umbrella, collecting or creating individually identifiable health information, is bound by the same stringent privacy and security rules. The information gathered, whether through a health risk assessment, biometric screening, or coaching session, becomes PHI the moment it is associated with the plan.

This connection is often evidenced by the incentive structure. If participation in the wellness program results in tangible benefits related to your health plan, such as reduced premiums, deductibles, or other cost-sharing advantages, the link is established. The U.S.

Department of Health and Human Services clarifies that this financial integration makes the wellness program a component of the health plan. Consequently, the plan must ensure that all PHI is handled in compliance with HIPAA’s Privacy, Security, and Breach Notification Rules. This includes restricting how the employer, as the plan sponsor, can access and use this sensitive information for employment-related decisions.

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What Is Protected Health Information?

Protected Health Information, or PHI, is the specific category of data that HIPAA was designed to shield. It encompasses any individually identifiable health information that is transmitted or maintained in any form or medium by a covered entity or its business associate. This definition is comprehensive, extending beyond clinical diagnoses or lab results. It includes a wide array of data points that, when linked to an individual, paint a detailed picture of their health status.

To understand its scope, consider the types of information often collected in wellness programs. These data points, once connected to your identity, all qualify as PHI if the program is part of a group health plan.

  • Biometric Screenings ∞ Measurements such as blood pressure, cholesterol levels, glucose, and body mass index (BMI).
  • Health Risk Assessments (HRAs) ∞ Questionnaires that gather information about your lifestyle, medical history, and even family medical history.
  • Genetic Information ∞ Data related to genetic tests, genetic services, or the health history of family members.
  • Participation Records ∞ Documentation of your involvement in specific wellness activities, like smoking cessation programs or health coaching sessions.
  • Demographic Data ∞ Information such as your name, address, birth date, and Social Security number when linked to health information.

The essence of PHI is its identifiability. When these data points can be traced back to you, they are protected. HIPAA mandates that covered entities implement robust safeguards ∞ administrative, physical, and technical ∞ to ensure the confidentiality, integrity, and availability of this information.


Intermediate

To determine if your employer’s wellness program is governed by HIPAA, you must analyze its operational design and its connection to the group health plan. The primary distinction lies in whether the program is an embedded benefit of the health plan or a standalone corporate initiative.

When a wellness program is part of a group health plan, it acts as an extension of that plan. The data collected, from biometric screenings to health risk assessments, is legally classified as PHI. This means the group health plan, as a covered entity, is directly responsible for ensuring that the collection, use, and disclosure of this information comply with HIPAA’s stringent standards.

The employer, in its role as the plan sponsor, may have access to some of this information for administrative purposes, but this access is tightly regulated.

Conversely, a program offered directly by the employer, with no linkage to the group health plan’s benefits or costs, operates outside of HIPAA’s jurisdiction. The information gathered in such a program is not PHI. This structural separation is key.

For instance, if an employer offers a gym membership subsidy available to all employees, regardless of their health plan enrollment, the data related to that program is likely not protected by HIPAA.

Other laws, such as the Americans with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act (GINA), still impose significant requirements on how employers handle employee health information, ensuring that participation is voluntary and the data is kept confidential. Understanding this structural distinction is the first step in assessing the legal protections afforded to your personal health data.

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How Is a Wellness Program Structured under a Group Health Plan?

A wellness program is considered part of a group health plan when it is integrated into the plan’s design and administration. This integration can manifest in several ways, and identifying these connections is crucial to determining HIPAA’s applicability. The most common indicator is the presence of incentives that affect the group health plan.

For example, if completing a biometric screening or participating in a health coaching program leads to a reduction in your monthly health insurance premiums, the wellness program is part of the group health plan. In this scenario, the individually identifiable health information collected is PHI because it is being used to administer benefits under the health plan.

Another structural indicator is the involvement of the health plan’s vendors or administrators in the wellness program. If the same company that administers your health insurance benefits also manages the wellness program, the two are likely intertwined. The flow of information between the wellness program and the health plan is a critical consideration.

If data from the wellness program is used to stratify risk, manage care, or determine eligibility for certain health plan benefits, it is PHI. The plan documents themselves, such as the Summary Plan Description (SPD), should also describe the wellness program as a feature of the health plan. These documents are legally required to outline the terms of the plan, and the inclusion of the wellness program is a definitive sign of its integrated status.

HIPAA’s governance extends to a wellness program when its incentives are directly tied to the costs or benefits of the group health plan.

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The Employer as Plan Sponsor

The role of the employer in relation to a HIPAA-covered wellness program is complex. While the employer itself is not a covered entity, it often acts as the “plan sponsor” and may be involved in the administration of the group health plan.

In this capacity, the employer may need access to PHI to perform certain administrative functions. However, HIPAA’s Privacy Rule places strict limits on how a group health plan can disclose PHI to a plan sponsor. To receive this information without patient authorization, the employer must amend the plan documents to establish specific safeguards. These amendments must certify that the employer will not use or disclose the PHI for any employment-related actions or in connection with any other benefit plan.

This “firewall” is a critical protection. It ensures that the health information you provide to a wellness program cannot be used to make decisions about your job, such as hiring, firing, or promotion. The employer must implement administrative, physical, and technical safeguards to protect the PHI it receives and ensure that only authorized employees have access to it.

If an employer performs administrative functions on behalf of the plan, a formal Business Associate Agreement (BAA) may also be required between the group health plan and the employer, further codifying these obligations.

HIPAA Applicability Based on Program Structure
Program Characteristic Part of Group Health Plan (HIPAA Applies) Directly Offered by Employer (HIPAA Does Not Apply)
Incentive Type Reductions in premiums, deductibles, or other cost-sharing. Cash, gift cards, or other rewards unrelated to health plan costs.
Data Collected Considered Protected Health Information (PHI). Considered employee health information, but not PHI.
Primary Governing Law HIPAA, ADA, GINA. ADA, GINA, and other state or federal laws.
Data Flow Information may be shared with the health plan for administration. Information is held by the employer or a third-party vendor.
Employer’s Role Plan Sponsor, with limited and regulated access to PHI. Program Administrator, with direct access to employee health data.
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What Are the Intersections with Other Federal Laws?

While HIPAA is a central piece of the regulatory puzzle, it operates in concert with other federal laws that also govern employer wellness programs. The Americans with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act (GINA) are particularly relevant. The ADA places restrictions on employers’ ability to make medical inquiries of employees.

Wellness programs that include health risk assessments or biometric screenings are permitted under the ADA only if participation is voluntary. This means that employers cannot require employees to participate, nor can they deny them health coverage or take adverse employment action if they choose not to participate. The incentives offered must not be so substantial as to be coercive.

GINA prohibits discrimination based on genetic information in both health insurance and employment. This law is particularly relevant to wellness programs that ask about family medical history in their health risk assessments. Under GINA, an employer cannot offer an incentive in exchange for an employee providing their genetic information, which includes the manifestation of disease in family members.

There are specific rules that allow for the collection of this information if it is truly voluntary and certain authorizations are in place. These laws apply to all employer wellness programs, regardless of whether they are part of a group health plan and covered by HIPAA. They provide a baseline of protection for employee health information, ensuring that participation is a matter of choice and that the data is handled with care.


Academic

A granular analysis of the regulatory framework governing employer wellness programs reveals that the applicability of HIPAA is a function of the program’s architectural integration with a group health plan, which is itself a “covered entity” under the statute.

The determinative question is whether the wellness program constitutes a component of the health plan or exists as a distinct, employer-administered entity. When the former is true, the individually identifiable health information collected from participants is axiomatically PHI, subject to the full panoply of protections afforded by the HIPAA Privacy, Security, and Breach Notification Rules.

This structural linkage is often established through the mechanism of financial incentives that modulate an employee’s contributions to the group health plan, such as premium discounts or adjustments to cost-sharing obligations.

In such integrated models, the group health plan bears the primary compliance burden. The employer, acting as the plan sponsor, may be granted access to PHI for purposes of plan administration, but only under circumscribed conditions.

Specifically, the plan documents must be amended to incorporate provisions that stringently limit the use and disclosure of PHI, effectively creating a legal and operational firewall between the plan administration functions and the employer’s other human resources functions. This construct is designed to prevent the use of sensitive health data in employment-related decisions, a core tenet of the Privacy Rule.

Conversely, when a wellness program is offered directly by the employer and is not a benefit of the group health plan, the information collected is not PHI, and HIPAA’s direct oversight is absent. This does not, however, create a regulatory vacuum. Other legal frameworks, notably the ADA and GINA, impose substantive obligations on the employer regarding the voluntariness of the program and the confidentiality of the information collected.

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What Are the Specific HIPAA Requirements for an Integrated Program?

When a wellness program is integrated with a group health plan, a specific set of HIPAA compliance obligations is triggered. The group health plan, as the covered entity, must ensure that all PHI is protected. This involves implementing comprehensive safeguards as mandated by the HIPAA Security Rule. These safeguards are categorized into three types ∞ administrative, physical, and technical.

  1. Administrative Safeguards ∞ These are the policies and procedures that govern the conduct of the workforce in relation to PHI. They include conducting a formal risk analysis to identify potential vulnerabilities, designating a security official responsible for compliance, implementing a security awareness and training program for all personnel with access to PHI, and establishing contingency plans for emergencies.
  2. Physical Safeguards ∞ These are the measures taken to protect physical access to PHI. They include controlling access to facilities where PHI is stored, implementing policies for the use of workstations and electronic media, and establishing procedures for the disposal of devices and media containing PHI.
  3. Technical Safeguards ∞ These are the technology-based controls used to protect electronic PHI (ePHI). They include implementing access controls to ensure that users can only access the minimum necessary information, using encryption to render ePHI unreadable to unauthorized individuals, and maintaining audit controls to record and examine activity in information systems that contain or use ePHI.

In addition to these security measures, the HIPAA Privacy Rule imposes strict limits on the use and disclosure of PHI. The group health plan can only use or disclose PHI for treatment, payment, and healthcare operations, or as otherwise permitted or required by the rule. Any disclosure to the employer as plan sponsor must be for plan administration purposes only and subject to the certification requirements previously discussed.

The application of HIPAA to a wellness program is determined by its functional and financial integration with the employer’s group health plan.

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How Does Data Flow and Vendor Management Affect Compliance?

The flow of data within a wellness program ecosystem is a critical area of focus for HIPAA compliance. Often, employers engage third-party vendors to administer their wellness programs. If the program is part of the group health plan, this vendor is considered a “business associate” under HIPAA.

A business associate is any person or entity that performs functions or activities on behalf of a covered entity that involve the use or disclosure of PHI. The relationship between the group health plan (the covered entity) and the wellness vendor (the business associate) must be governed by a formal, written Business Associate Agreement (BAA).

The BAA is a legally binding contract that requires the business associate to implement the same level of safeguards for PHI as the covered entity. It outlines the permissible uses and disclosures of PHI by the vendor, requires the vendor to report any security incidents or breaches to the covered entity, and ensures that the vendor will extend the same protections to any subcontractors it may use.

The presence of a BAA is a non-negotiable requirement of HIPAA. Without one, the disclosure of PHI from the group health plan to the wellness vendor is a violation of the Privacy Rule. Therefore, a key step in determining if a program is HIPAA-compliant is to ascertain whether these vendor relationships are properly documented and managed.

Key Legal Frameworks for Wellness Programs
Statute Primary Focus Applicability Key Requirement
HIPAA Privacy and security of Protected Health Information (PHI). Programs offered as part of a group health plan. Implementation of administrative, physical, and technical safeguards.
ADA Prohibits disability-based discrimination and regulates medical inquiries. All wellness programs that include medical inquiries or exams. Participation must be voluntary; incentives cannot be coercive.
GINA Prohibits discrimination based on genetic information. All wellness programs. Strict limits on collecting genetic information, including family history.

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References

  • Ward and Smith, P.A. “Employer Wellness Programs ∞ Legal Landscape of Staying Compliant.” July 11, 2025.
  • Paubox. “HIPAA and workplace wellness programs.” September 11, 2023.
  • Compliancy Group. “HIPAA Privacy and Security and Workplace Wellness Programs.” February 13, 2024.
  • Barrow Group Insurance. “Workplace Wellness Programs ∞ ERISA, COBRA and HIPAA.” November 6, 2024.
  • Compliancy Group. “HIPAA Workplace Wellness Program Regulations.” October 26, 2023.
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Reflection

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What Does This Mean for Your Health Journey?

The knowledge of how your health data is classified and protected forms a critical part of your personal wellness architecture. Understanding the distinction between a wellness program governed by HIPAA and one that is not allows you to make informed decisions about your participation.

This awareness is the first step in actively managing your health information. It prompts a deeper inquiry into the structure of the programs offered to you and the pathways your data will travel. As you continue to engage with systems designed to support your well-being, let this understanding be a tool for advocacy ∞ for your own privacy and for the integrity of your health narrative.

The ultimate goal is to create a partnership with these programs that is built on a foundation of transparency and trust, allowing you to focus on the vital work of optimizing your own biological systems.

Glossary

group health plan

Meaning ∞ A Group Health Plan is a form of medical insurance coverage provided by an employer or an employee organization to a defined group of employees and their eligible dependents.

health information

Meaning ∞ Health information is the comprehensive body of knowledge, both specific to an individual and generalized from clinical research, that is necessary for making informed decisions about well-being and medical care.

protected health information

Meaning ∞ Protected Health Information (PHI) is a term defined under HIPAA that refers to all individually identifiable health information created, received, maintained, or transmitted by a covered entity or its business associate.

wellness program

Meaning ∞ A Wellness Program is a structured, comprehensive initiative designed to support and promote the health, well-being, and vitality of individuals through educational resources and actionable lifestyle strategies.

covered entities

Meaning ∞ Covered Entities are specific organizations or individuals designated by the Health Insurance Portability and Accountability Act (HIPAA) that must comply with its regulations regarding the protection of patient health information.

health plan

Meaning ∞ A Health Plan is a comprehensive, personalized strategy developed in collaboration between a patient and their clinical team to achieve specific, measurable wellness and longevity objectives.

wellness programs

Meaning ∞ Wellness Programs are structured, organized initiatives, often implemented by employers or healthcare providers, designed to promote health improvement, risk reduction, and overall well-being among participants.

individually identifiable health information

Meaning ∞ Individually Identifiable Health Information (IIHI) is any demographic, genetic, physiological, or psychological data, whether past, present, or future, that is created or received by a healthcare provider or plan and that can be used to identify an individual.

cost-sharing

Meaning ∞ Cost-Sharing delineates the portion of healthcare expenditures, such as advanced diagnostic testing for endocrine disorders or specialized hormone replacement therapy, that the insured individual is responsible for paying out-of-pocket.

breach notification rules

Meaning ∞ Breach Notification Rules, in the context of digital health, are the regulatory mandates dictating the timely and specific communication required following unauthorized access or disclosure of protected health information, including sensitive hormonal assay results or genetic data.

business associate

Meaning ∞ A Business Associate is a person or entity that performs certain functions or activities on behalf of a covered entity—such as a healthcare provider or health plan—that involve the use or disclosure of protected health information (PHI).

wellness

Meaning ∞ Wellness is a holistic, dynamic concept that extends far beyond the mere absence of diagnosable disease, representing an active, conscious, and deliberate pursuit of physical, mental, and social well-being.

biometric screenings

Meaning ∞ Biometric Screenings are clinical assessments that involve measuring key physiological characteristics to evaluate an individual's current health status and quantify their risk for developing chronic diseases.

health risk assessments

Meaning ∞ Health Risk Assessments (HRAs) are systematic clinical tools used to collect individual health data, including lifestyle factors, medical history, and biometric measurements, to estimate the probability of developing specific chronic diseases or health conditions.

genetic information

Meaning ∞ Genetic information refers to the hereditary material encoded in the DNA sequence of an organism, comprising the complete set of instructions for building and maintaining an individual.

health coaching

Meaning ∞ Health Coaching, in this context, is a collaborative, evidence-based process designed to facilitate sustained behavior modification that positively impacts endogenous hormone production and signaling.

health

Meaning ∞ Within the context of hormonal health and wellness, health is defined not merely as the absence of disease but as a state of optimal physiological, metabolic, and psycho-emotional function.

hipaa

Meaning ∞ HIPAA, which stands for the Health Insurance Portability and Accountability Act of 1996, is a critical United States federal law that mandates national standards for the protection of sensitive patient health information.

initiative

Meaning ∞ Initiative, in this context, is the measurable biological expression of self-starting behavior, directly linked to neuroendocrine drive and resource allocation governed by the autonomic nervous system.

risk assessments

Meaning ∞ Risk Assessments in the clinical context are systematic evaluations of an individual's probability of developing specific diseases or experiencing adverse health events based on a comprehensive analysis of genetic, lifestyle, and biomarker data.

plan sponsor

Meaning ∞ In the context of employee benefits and health insurance, a Plan Sponsor is the entity, typically an employer, union, or association, that establishes and maintains a health or welfare benefit plan for its participants.

phi

Meaning ∞ PHI, an acronym for Protected Health Information, is a critical regulatory term that refers to any information about health status, provision of healthcare, or payment for healthcare that can be linked to a specific individual.

genetic information nondiscrimination act

Meaning ∞ The Genetic Information Nondiscrimination Act, commonly known as GINA, is a federal law in the United States that prohibits discrimination based on genetic information in two main areas: health insurance and employment.

incentives

Meaning ∞ In the context of hormonal health and wellness, incentives are positive external or internal motivators, often financial, social, or psychological rewards, that are deliberately implemented to encourage and sustain adherence to complex, personalized lifestyle and therapeutic protocols.

biometric screening

Meaning ∞ Biometric screening is a clinical assessment that involves the direct measurement of specific physiological characteristics to evaluate an individual's current health status and risk for certain chronic diseases.

health insurance

Meaning ∞ Health insurance is a contractual agreement where an individual or entity receives financial coverage for medical expenses in exchange for a premium payment.

covered entity

Meaning ∞ A Covered Entity is a legal term in the United States, specifically defined under the Health Insurance Portability and Accountability Act (HIPAA), referring to three types of entities: health plans, healthcare clearinghouses, and healthcare providers who transmit health information electronically.

privacy rule

Meaning ∞ The Privacy Rule is the specific federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) that establishes comprehensive national standards for protecting the confidentiality of individually identifiable health information, which is formally designated as Protected Health Information, or PHI.

technical safeguards

Meaning ∞ Technical safeguards are the electronic and technological security measures implemented to protect sensitive electronic health information (EHI) from unauthorized access, disclosure, disruption, or destruction.

business associate agreement

Meaning ∞ A Business Associate Agreement, commonly referred to as a BAA, is a legally binding contract required under the Health Insurance Portability and Accountability Act (HIPAA) between a covered entity and a business associate.

genetic information nondiscrimination

Meaning ∞ Genetic Information Nondiscrimination refers to the legal and ethical principle that prohibits the use of an individual's genetic test results or family medical history in decisions regarding health insurance eligibility, coverage, or employment.

ada

Meaning ∞ In the clinical and regulatory context, ADA stands for the Americans with Disabilities Act, a comprehensive civil rights law that prohibits discrimination based on disability.

family medical history

Meaning ∞ Family Medical History is the clinical documentation of health information about an individual's first- and second-degree relatives, detailing the presence or absence of specific diseases, particularly those with a genetic or strong environmental component.

employee health information

Meaning ∞ Employee Health Information refers to any data related to an individual's past, present, or future physical or mental health condition, the provision of healthcare to the individual, or the payment for that healthcare, which is collected or maintained by an employer or a related entity.

employer wellness programs

Meaning ∞ Employer Wellness Programs are formal initiatives implemented by organizations to support and improve the health and well-being of their workforce through education, preventative screenings, and incentive structures.

breach notification

Meaning ∞ In the clinical and regulatory context, Breach Notification refers to the mandatory process of informing affected individuals, and often regulatory bodies, following an unauthorized acquisition, access, use, or disclosure of unsecured protected health information (PHI).

compliance

Meaning ∞ In the context of hormonal health and clinical practice, Compliance denotes the extent to which a patient adheres to the specific recommendations and instructions provided by their healthcare provider, particularly regarding medication schedules, prescribed dosage, and necessary lifestyle changes.

health data

Meaning ∞ Health data encompasses all quantitative and qualitative information related to an individual's physiological state, clinical history, and wellness metrics.

legal frameworks

Meaning ∞ Legal Frameworks are the binding statutes, regulations, and ethical guidelines that delineate the permissible scope of practice for clinicians managing complex hormonal therapies or utilizing advanced diagnostic data.

hipaa security rule

Meaning ∞ The HIPAA Security Rule is a specific federal regulation in the United States that establishes national standards to protect individuals' electronic protected health information (ePHI) that is created, received, used, or maintained by a covered entity.

ephi

Meaning ∞ An acronym that stands for Electronic Protected Health Information, representing any patient health information created, received, stored, or transmitted in an electronic format by a covered entity or its business associate.

hipaa privacy rule

Meaning ∞ The HIPAA Privacy Rule establishes national standards to protect individuals' medical records and other personal health information (PHI) and applies to health plans, healthcare clearinghouses, and most healthcare providers.

hipaa compliance

Meaning ∞ HIPAA Compliance refers to the adherence to the standards and requirements of the Health Insurance Portability and Accountability Act of 1996, a federal law that mandates the protection and confidential handling of sensitive patient health information (PHI).

wellness vendor

Meaning ∞ A Wellness Vendor is a specialized, third-party organization or external service provider contracted to expertly deliver specific health and well-being programs, products, or specialized services to an organization's employee base or a clinical practice's patient population.

same

Meaning ∞ SAMe, or S-adenosylmethionine, is an endogenous sulfonium compound functioning as a critical methyl donor required for over one hundred distinct enzymatic reactions within human physiology.

privacy

Meaning ∞ Privacy, within the clinical and wellness context, is the fundamental right of an individual to control the collection, use, and disclosure of their personal information, particularly sensitive health data.

focus

Meaning ∞ Focus, in the context of neurocognitive function, refers to the executive ability to selectively concentrate attention on a specific task or stimulus while concurrently inhibiting distraction from irrelevant information.