How do mobile health apps and digital health tools intersect with HIPAA-covered entities?

by | May 30, 2023 | HIPAA News and Advice

Mobile health apps and digital health tools intersect with HIPAA-covered entities by being subject to the regulations outlined in HIPAA when they transmit, store, or process individually identifiable health information on behalf of healthcare providers, health plans, or healthcare clearinghouses, necessitating compliance with privacy and security requirements to ensure the protection of patients’ sensitive health data. Mobile health apps and digital health tools have become important components of modern healthcare delivery, offering unprecedented opportunities for patient engagement, remote monitoring, and personalized health management. However, their intersection with entities covered by the HIPAA has introduced complex considerations regarding data privacy, security, and compliance.

HIPAA Regulations and PHI HandlingMobile health apps and digital health tools handling PHI are considered business associates under HIPAA.
They must comply with HIPAA’s privacy and security requirements when dealing with PHI.
Business Associate RelationshipBusiness associates sign a business associate agreement (BAA) with covered entities, outlining responsibilities and PHI protection obligations.
Technical SafeguardsStrong encryption mechanisms are necessary for securing PHI during transmission and at rest.
Firewalls, intrusion detection systems, and access controls prevent unauthorized access and breaches.
Administrative SafeguardsPolicies and procedures for PHI use, access, and disclosure must align with the HIPAA Security Rule.
Regular workforce training ensures compliance awareness among employees and stakeholders.
Risk AssessmentsRisk assessments identify vulnerabilities and threats to PHI’s confidentiality and integrity.
Safeguards are implemented based on identified risks.
Vendor ManagementCovered entities assess vendor security practices and HIPAA compliance before engagement.
Business associate agreements ensure vendors adhere to regulations and maintain patient data privacy and security.
Software Updates and PatchingRegular software updates and patching address security vulnerabilities.
Careful management prevents disruption of important health services and maintains HIPAA compliance.
Incident Response PlanA plan outlining the steps for addressing data breaches or security incidents.
Notification procedures for affected individuals and regulatory authorities are established.
Patient Consent and AuthorizationMobile health apps and digital health tools must obtain appropriate patient consent or authorization for data collection and usage.
Consent is required for purposes beyond treatment, payment, and healthcare operations.
Remote Monitoring and Data SharingMobile health tools enable remote monitoring and data sharing between patients and healthcare providers.
Robust security measures are necessary to safeguard against unauthorized access.
Compliance Audits and ReviewsHIPAA-covered entities undergo compliance audits and reviews by the Office for Civil Rights (OCR).
Mobile health app and digital health tool vendors serving as business associates may also be audited.
Table: HIPAA Compliance Required for Mobile Health Apps and Digital Health Tools

HIPAA, enacted in 1996, establishes regulations and standards to safeguard PHI and ensure its confidentiality, integrity, and availability. HIPAA-covered entities, including healthcare providers, health plans, and healthcare clearinghouses, are obligated to adhere to these regulations. In recent years, the increase of mobile health apps and digital health tools has introduced new challenges and dimensions to HIPAA compliance. When mobile health apps and digital health tools handle individually identifiable health information on behalf of HIPAA-covered entities, they are considered business associates under HIPAA. Business associates are external entities that provide services involving the use or disclosure of PHI, such as data storage, processing, or transmission, on behalf of covered entities. This expanded scope of entities has necessitated specific legal obligations and technical safeguards to maintain compliance.

Mobile health apps and digital health tools often involve the exchange of sensitive data over the internet or other communication channels. This requires considerations for the security of PHI during transmission and storage. Implementing strong encryption mechanisms safeguards this data from unauthorized access or interception. The data should be encrypted both during transmission and while at rest on servers or storage systems. Entities developing and providing these technologies must conduct risk assessments to identify potential vulnerabilities and threats to the confidentiality and integrity of PHI. These assessments, in alignment with the HIPAA Security Rule, should inform the implementation of appropriate safeguards, such as firewalls, intrusion detection systems, and access controls, to mitigate identified risks.

Besides technical safeguards, administrative safeguards play an important role in HIPAA compliance. Business associates must establish policies and procedures that govern the use, access, and disclosure of PHI. This includes defining roles and responsibilities, conducting workforce training on data security and privacy practices, and enforcing sanctions for breaches of policies. As the landscape of mobile health and digital tools evolves rapidly, maintaining an up-to-date training program for employees and stakeholders is important to ensure ongoing compliance awareness. A challenge in the realm of mobile health apps and digital health tools lies in the changing nature of technology updates and integrations. Regularly updating and patching software and applications is a must to address security vulnerabilities and vulnerabilities that may arise over time. However, these updates must be carefully managed to avoid disrupting the functionality of health services and to maintain compliance with HIPAA requirements.

Vendor management is also important for HIPAA-covered entities. Before engaging with a mobile health app or digital health tool vendor, a thorough assessment of the vendor’s security practices, data handling procedures, and compliance with HIPAA is necessary. The entity must establish a business associate agreement (BAA) with the vendor that outlines the responsibilities and obligations of both parties in safeguarding PHI. This legal contract serves as an important mechanism for ensuring that vendors adhere to HIPAA regulations and maintain the privacy and security of patient data.

While there are potential benefits of mobile health apps and digital health tools, the risks associated with their use in a healthcare context cannot be ignored. Data breaches and HIPAA privacy violations have the potential to not only harm individuals but also result in legal and financial consequences for covered entities and their business associates. To address these risks, an incident response plan should be in place. This plan outlines the steps to be taken in the event of a data breach or security incident. It includes procedures for notifying affected individuals, reporting the breach to the appropriate regulatory authorities, and conducting investigations to determine the extent of the breach and the actions required to prevent future occurrences.


The relation of mobile health apps and digital health tools with HIPAA-covered entities demands attention to privacy, security, and compliance. Ensuring that these technologies align with the requirements of HIPAA involves a combination of technical, administrative, and legal measures. As the healthcare ecosystem continues to evolve, the collaboration between technology developers, healthcare providers, and regulatory bodies becomes important to strike a balance between innovation and patient data protection.

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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