Can a patient sue a HIPAA-covered entity for a data breach?

by | Jul 4, 2023 | HIPAA News and Advice

Yes, a patient can potentially sue a HIPAA-covered entity for a data breach if the breach results from the entity’s failure to adequately safeguard PHI, leading to the unauthorized disclosure of that information and causing harm or damages to the patient, as HIPAA regulations require covered entities to maintain the confidentiality and security of patient data. A patient’s capacity to initiate legal proceedings against entities governed by HIPAA hinges upon considerations about the entity’s obligations under the law, the extent of the breach, the subsequent harm suffered by the patient, and the legal standing.

Key AspectsDetails
HIPAA FrameworkHIPAA regulates PHI protection for covered entities like healthcare providers, health plans, and healthcare clearinghouses.
HIPAA Privacy, Security, and Breach Notification Rules outline guidelines for PHI safeguarding and breach response.
Breach and NotificationBreaches occur with unauthorized access, disclosure, or acquisition of PHI, especially ePHI.
Covered entities must assess the risk and notify affected individuals, HHS, and possibly the media when a risk is identified.
Legal Action PossibilityPatients (referred to as “individuals” under HIPAA) can potentially sue covered entities for breach-related issues.
Suit viability hinges on the entity’s security adherence, breach extent, patient harm, and legal standing.
Security Rule ComplianceHIPAA Security Rule mandates administrative, physical, and technical safeguards for ePHI protection.
An entity’s negligence or failure to implement reasonable security measures can aid a patient’s legal standing.
Breach Impact on LawsuitEstablishing a causal link between breach and patient harm is necessary for a lawsuit.
While HIPAA lacks a private cause of action, state laws may allow patients to sue for statutory damages due to breach-related harm.
Demonstrating HarmPatients must show that the breach directly led to financial, reputational, or emotional harm.
Evidence of breached PHI exploitation causing concrete injuries (e.g., identity theft) strengthens the patient’s case.
Standing RequirementLegal standing requires proving actual or imminent concrete injury due to breach, not speculative harm.
Court interpretations of standing in healthcare breaches can vary, impacting a patient’s lawsuit potential.
Class Action ConsiderationsClass actions involve multiple affected individuals collectively suing the entity.
Class certification demands showing commonality, typicality, adequacy, and numerosity among class members.
Interplay with State LawsHIPAA sets federal standards, but patients can also pursue action under state laws offering added protections or avenues.
State attorneys general can enforce HIPAA violations and seek damages for affected individuals.
HITECH Act ImpactHITECH Act enhanced HIPAA’s penalties and enforcement mechanisms.
State attorneys general can seek damages on behalf of affected individuals, enhancing enforcement capabilities.
Legal Landscape AwarenessCovered entities must follow HIPAA safeguards and be attentive to potential breach-related legal consequences.
Robust data protection measures are required to mitigate the risk of legal actions.
Table: Points to Consider Before Taking Legal Action Against HIPAA-Covered Entities

In the event a data breach occurs within a HIPAA-covered entity, leading to unauthorized access, disclosure, or acquisition of PHI, do patients, commonly referred to as “individuals” under HIPAA, possess the right to explore potential legal action against the covered entity? The viability of a lawsuit hinges upon a variety of determinants. One consideration is the covered entity’s adherence to its obligations for PHI protection, as outlined in the HIPAA Security Rule. This rule requires administrative, physical, and technical safeguards to secure electronic PHI (ePHI). Should a breach result from the entity’s negligence, oversight, or failure to implement reasonable security measures, the patient’s legal prospects gain traction.

The scope and nature of the breach are important considerations. If the breach, regardless of its origin, triggers compromise of unencrypted ePHI, it immediately triggers the presumption of a “breach” under the HIPAA Breach Notification Rule. The covered entity is compelled to perform a risk assessment to determine the probability of PHI compromise. Should the assessment indicate a risk, the entity is legally obligated to notify affected individuals, the Department of Health and Human Services (HHS), and, potentially, the media. After the breach notification, the affected patient may, in certain circumstances, initiate legal action against the covered entity. The progress of the lawsuit largely depends on the ability to establish causation between the breach and the harm suffered. While HIPAA itself does not provide for a private cause of action, it does establish a framework where state laws could apply. Some states grant patients the right to sue for statutory damages if a healthcare provider’s breach results in harm.

Demonstrating harm, however, can be complicated. HIPAA identifies “harm” as including financial, reputational, and emotional damages. Patients must provide evidence that the breach directly led to such harm. In some cases, this involves proving that the breached PHI was subsequently exploited, leading to identity theft, fraud, or other concrete injuries. Establishing this causal link is required for seeking legal redress. The concept of “standing” support the patient’s capacity to sue. Courts often require plaintiffs to demonstrate an actual or imminent injury that is concrete and particularized, not conjectural or hypothetical. In case of a data breach, this means showcasing that the breach has or is likely to, cause harm. Courts have varied in their interpretations of this standing requirement with regard to healthcare data breaches. Further difficulties are seen with class action lawsuits, where multiple affected individuals collectively initiate legal action. Class certification necessitates demonstrating commonality, typicality, adequacy, and numerosity, which can be a complex undertaking. Courts may scrutinize whether the claims of the representative plaintiff are reflective of the class and whether the proposed class members share similar factual and legal issues.

While HIPAA establishes federal standards for PHI protection, it does not serve as an exclusive remedy. Patients have recourse to state laws that may afford additional protections or avenues for legal action. The scenario is marked by heterogeneity, as state statutes and common law doctrines interact with the federal framework. The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009, introduced modifications to HIPAA, expanding its penalties and enforcement mechanisms. State attorneys general are empowered to bring civil actions for HIPAA violations and can seek damages on behalf of affected individuals. This added layer of enforcement widens the potential for legal action.


A patient’s ability to sue a HIPAA-covered entity for a data breach is a complex matter subject to a confluence of factors. HIPAA’s framework establishes standards for PHI protection and breaches triggering a risk necessitate patient notification. The patient’s capacity to pursue legal action, however, is contingent upon a demonstrated causal link between the breach and harm suffered. The interaction between federal and state laws, standing requirements, class action dynamics, and the evolving legal system collectively shape the potential legal proceedings. Healthcare entities must not only comply with HIPAA’s safeguards but also be attentive to the legal consequences should a breach occur.

HIPAA Covered Entity Topics

What is the definition of a HIPAA-covered entity?
How does an organization determine if it is a HIPAA-covered entity?
Are all healthcare providers considered HIPAA-covered entities?
What obligations does an entity covered by HIPAA have concerning patient data?
Do insurance companies fall under the category of entities covered by HIPAA?
What is a covered entity under HIPAA?
Who would not be considered a covered entity under HIPAA?
Is an employer a covered entity under HIPAA?
Who should HIPAA complaints be directed to within the covered entity?
What are the penalties for a HIPAA-covered entity that breaches patient confidentiality?
Are health technology companies automatically considered HIPAA-covered entities?
What distinguishes a HIPAA entity from non-covered entities?
Can a HIPAA-covered entity share medical records with another such entity without patient consent?
How often should HIPAA-covered entities review their compliance procedures?
What types of training must employees of an entity covered by HIPAA undergo?
How do entities covered by HIPAA handle data breaches?
What is the role of a privacy officer in a HIPAA-covered entity?
Are dental practices considered HIPAA-covered entities?
Can a patient sue a HIPAA-covered entity for a data breach?
How are HIPAA-covered entities audited for compliance?
What are the reporting obligations of a HIPAA entity in case of data exposure?
How do third-party vendors interact with HIPAA-covered entities?
Can a business associate be considered a HIPAA-covered entity?
How should a HIPAA entity respond to unauthorized access to protected health information?
What security measures must entities covered by HIPAA implement?
Are there exemptions for certain types of entities covered by HIPAA?
How long must a HIPAA-covered entity retain medical records?
What patient rights are recognized by entities covered by HIPAA concerning their personal data?
Are telemedicine platforms typically classified as HIPAA-covered entities?
What distinguishes business associates from HIPAA-covered entities?
How can patients file complaints against a HIPAA entity?
What is the significance of the Notice of Privacy Practices for a HIPAA-covered entity?
How do international medical tourism practices intersect with HIPAA-covered entities?
Are there specific encryption standards that a HIPAA-covered entity must adhere to?
How do federal and state laws regarding patient privacy relate to HIPAA-covered entities?
How do HIPAA-covered entities handle minor patient information?
Are pharmacies and drug stores universally categorized as HIPAA-covered entities?
How can a HIPAA-covered entity ensure compliance when integrating new technologies?
What are the key differences between a HIPAA-covered entity and a HIPAA business associate?
Are research institutions always considered HIPAA-covered entities?
What are the boundaries of marketing activities for an entity covered by HIPAA?
Can cloud service providers be classified as HIPAA-covered entities?
How should a HIPAA entity prepare for an official audit or review?
What documentation is essential for a HIPAA-covered entity’s compliance processes?
How often do regulations impacting HIPAA-covered entities get updated?
Do educational institutions fall under the scope of entities covered by HIPAA?
How do mobile health apps and digital health tools intersect with HIPAA-covered entities?
What is the role of electronic health record systems in a HIPAA-covered entity?
How does the Health Information Exchange (HIE) network impact HIPAA-covered entities?
Are mental health professionals bound by the same rules as other HIPAA-covered entities?
How do mergers and acquisitions impact the status of a HIPAA-covered entity?
Can patients access all their health data held by a HIPAA-covered entity?
Are billing and invoicing data handled differently by entities covered by HIPAA than medical data?
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