What obligations does an entity covered by HIPAA have concerning patient data?

by | Aug 13, 2023 | HIPAA News and Advice

An entity covered by HIPAA is obligated to ensure the security and confidentiality of patient data by implementing appropriate administrative, physical, and technical safeguards, obtaining patient consent for certain uses and disclosures of their PHI, providing individuals with notice of privacy practices, granting patients access to their own health records, maintaining data breach notification protocols, and adhering to stringent regulations aimed at protecting the privacy and integrity of patient data. These obligations stem from the requirement of safeguarding sensitive health information while facilitating the exchange of important medical data for treatment, payment, and healthcare operations.

Safeguarding MeasuresImplement administrative, physical, and technical safeguards to protect ePHI.
Conduct regular risk assessments to identify vulnerabilities.
Develop contingency plans for data breaches and security incidents.
Patient Consent and AuthorizationObtain patient consent for specific uses and disclosures of their health information.
Secure written authorization for non-routine purposes outside of treatment, payment, and healthcare operations.
Privacy Practices DisclosureProvide a clear notice of privacy practices explaining how patient information will be used and protected.
Detail patient rights related to accessing, amending, and requesting restrictions on their health data.
Patient Access to Health RecordsGrant patients access to their health records, including electronic copies if stored electronically.
Establish an efficient process for patients to obtain their medical information in a timely manner.
Data Breach NotificationDevelop protocols for detecting and responding to data breaches.
Notify affected individuals, HHS, and potentially the media for breaches impacting over 500 individuals.
Ensure transparent communication post-breach.
Penalties and EnforcementUnderstand potential penalties for HIPAA violations based on negligence levels.
Acknowledge the financial and reputational implications of non-compliance.
Ensure adherence to regulations to mitigate risks.
Employee TrainingConduct regular training for the workforce on HIPAA, privacy practices, and security protocols.
Promote awareness of compliance and accountability among employees handling patient data.
Access Controls and EncryptionImplement access controls to limit authorized access to patient data.
Use encryption to secure ePHI during storage and transmission.
Mitigate unauthorized access and interception risks.
Audit Logs and MonitoringMaintain audit logs tracking access and modifications to patient data.
Regularly monitor systems to detect and address potential security breaches.
Ensure swift response to unauthorized or suspicious activities.
Business Associate AgreementsEstablish agreements with business associates handling patient data.
Ensure compliance with HIPAA and data security requirements.
Maintain confidentiality and security of patient information when shared with associates.
Continual Compliance ReviewPeriodically review and update policies to reflect changes in technology and regulations.
Engage in self-assessments and external audits to ensure ongoing adherence to HIPAA requirements.
Table: Key Obligations of Entities Covered by HIPAA

HIPAA requires the establishment of a framework of administrative, physical, and technical safeguards. These safeguards collectively form the foundation of the HIPAA Security Rule, which aims to protect electronic protected health information (ePHI) from unauthorized access, use, or disclosure. Administrative safeguards include policies and procedures that address risk management, workforce HIPAA training, and security management. This involves conducting regular risk assessments, implementing contingency plans for data breaches, and training employees on security protocols to ensure compliance throughout the entity.

Physical safeguards focus on the physical protection of electronic systems and the facilities housing them. This involves implementing controls such as access controls, security cameras, and alarm systems to prevent unauthorized individuals from physically accessing areas where ePHI is stored. Technical safeguards revolve around the technological mechanisms employed to secure ePHI. Measures like encryption, access controls, and audit logs help ensure that only authorized personnel can access, modify, or transmit sensitive patient data electronically. Entities covered by HIPAA must obtain patient consent for certain uses and disclosures of their protected health information. This requirement is covered within the HIPAA Privacy Rule, which provides patients with control over their health information and how it is used. Covered entities must obtain written authorization from patients for any non-routine disclosures of their health information, such as for research purposes or marketing initiatives. However, disclosures for treatment, payment, and healthcare operations can be carried out without explicit patient consent.

To emphasize patient rights and control, the HIPAA Privacy Rule requires covered entities to furnish individuals with a notice of privacy practices. This notice outlines how the entity will use and disclose patient information, as well as detailing the patient’s rights under HIPAA. By providing this information, entities offer transparency and empower patients to make informed decisions regarding their health information. HIPAA grants patients the right to access their own health records. The HIPAA Privacy Rule entitles patients to obtain copies of their medical records, including electronic copies if they are maintained in electronic format. This not only promotes patient engagement in their own care but also enhances transparency and accountability within the healthcare system.

In the event of a data breach that compromises the security or privacy of patient information, covered entities are obligated to adhere to stringent breach notification protocols. The HIPAA Breach Notification Rule stipulates that entities must promptly notify affected individuals, the U.S. Department of Health and Human Services (HHS), and, in some cases, the media, of any breach involving more than 500 individuals. Timely and transparent communication in the aftermath of a breach is important for protecting affected individuals and protecting public trust. Non-compliance with HIPAA regulations can lead to severe consequences, including financial penalties and reputational damage. The HITECH Act, an amendment to HIPAA, introduced increased penalties for HIPAA violations, thereby highlighting the importance of adherence to the regulations. Penalties are assessed based on the level of negligence, ranging from unknowing violations to willful neglect, and can amount to significant financial liabilities.


Entities covered by HIPAA bear a substantial responsibility in safeguarding patient data while facilitating the provision of healthcare services. By diligently adhering to administrative, physical, and technical safeguards, obtaining patient consent for specific uses and disclosures, providing transparent privacy practices, granting patients access to their health records, and diligently addressing breaches, covered entities not only fulfill legal obligations but also contribute to the trust and integrity of the healthcare ecosystem. With the changing healthcare system and technology, these obligations remain important for maintaining patient privacy and data security.

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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