There are three key parameters that determine whether an app should be regulated by HIPAA. Let’s browse through those:
1. Entity
If a covered entity such as a physician, hospital, or health insurance company uses an application, it would most definitely have to meet HIPAA standards.
Apps that facilitate doctor-patient interactions would need to comply with HIPAA; they work for covered entities like a doctor and a hospital. Simultaneously, an app that actually helps a patient follow a schedule for medication does not qualify for HIPAA because there is no protected agency involved in this scenario (that is if the patient enters information itself and no doctor sees it).
Two categories of companies are subjected to HIPAA, under the Privacy Rule:
1.1. Covered entities
These are typically the healthcare programs, healthcare clearinghouses, and healthcare providers that handle certain financial and administrative transfers electronically, such as digital payments and fund transfers, for which the Secretary for Health and Human Services has implemented certain guidelines.
1.2. Business associates.
Entities that collect, store, process, or transfer PHI on behalf of the protected health entities.
To ensure PHI’s security and overall compliance with HIPAA, a covered entity must sign a HIPAA business associate agreement with each of its business partners.
2. Data
HIPAA is typically concerned with protected health information(PHI), which is any type of health information that could easily distinguish a patient, as well as any information that is created, accessed, or disclosed during and after the provision of managed healthcare services, like those of the diagnosis or treatment.
PHI comprises two parts: health information and data that is personally identifiable. The health records only become PHI when personal identifying information is linked to medical data.
2.1. Data subjected to HIPAA regulations
The US Department of Health and Human Services identifies 18 types of personal information that along with health data account for the PHI:
- The name of a patient
- All subdivisions smaller than a State
- Dates related specifically to a person including date of birth, date of admission, date of discharge, date of death
- Fax numbers
- Phone numbers
- Email IDs
- Medical record numbers
- Social security numbers
- Health plan beneficiary numbers
- Certificate/license numbers
- Account numbers
- Device identifiers and serial numbers
- Vehicle identifiers and serial numbers, including license plate numbers
- Web URLs
- IP addresses
- Biometric identifiers, including voice and fingerprints
- Photos of full face and other corresponding pictures
- Any other unique number, feature, or code identifier
In short, if the data collected and shared in an application can be used to identify an individual (e.g. a profile that includes the first and the last names of a user and can be traced back to a patient), then the app must address the required HIPAA standards.
3. Software Security
The final requirement for deciding whether a telehealth app falls under HIPAA is specifically related to the technologies used. This covers a range of tenets for securing and regulating access to electronically protected health information (ePHI).
The criteria include audit, integrity, and access controls. Let’s look at every single one of them one by one,
3.1. Audit controls
Audit controls mean that a developer of health apps needs to incorporate hardware, software, and/or procedural mechanisms that document and analyze activities in systems containing or using ePHI.
3.2. Integrity of ePHI
This requires that a protected entity enforce policies and procedures to protect ePHI from unauthorized interference or damage.
3.3 Access controls
To clarify this standard, let’s look at some of its implementation requirements:
- Specific user identification
- Emergency access protocol
- Automatic logoff
- Encryption and decryption