Software development companies that want to enter the healthcare industry have to remember about HIPAA compliance regulations. It’s crucial to follow these strict rules if a MedTech app is targeted for users of the USA. HIPAA rules are enforced by the US legislation, and companies that don’t comply with the requirements for patient data security and privacy can be fined with tremendous penalties.
HIPAA compliance for medical software applications may be challenging to understand because some healthcare apps are subject to HIPAA regulations while others are not. In this article, we’ll discuss what HIPAA means for IT professionals and what it means to be HIPAA compliant.
What Is HIPAA?
HIPAA stands for the Health Insurance Portability and Accountability Act. It governs 2 critical branches – the HIPAA Privacy and Security Rules that protect private health information related to a specific patient.
The Protected Health Information (PHI) relates to 18 specific factors about a person that can be used to determine their identity. PHI includes a person’s first and last name, date of birth, address, emails, medical records, credit cards, social security numbers, passwords, photographic images, etc. To determine whether the software needs to be HIPAA compliant, it’s essential to understand what data is considered to be PHI.
Speaking about medical software applications, HIPAA compliance means that the software meets the HIPAA Security Rule’s technical and physical safeguards. The term HIPAA means that you, your software, and the premises you work in are compliant with the HIPAA Compliance Guide.
Whom Does HIPAA Apply to?
HIPAA applies to two particular types of entities or businesses – a Covered Entity and a Business Associate. Covered Entities include healthcare providers, and Business Associates are third-party service providers to HIPAA Covered Entities who have access to PHI (Protected Health Information).
Healthcare software development companies that deal with solutions that reveal, collect, and process personal identifiers of patients and do work for a Covered Entity or Business Associate are considered Business Associates by definition and thereby are legally bound by the governmental HIPAA regulations. In such cases, the independent software developers should sign a Business Associate Agreement that highlights the allowed use of the PHI.
Are Medical Apps Subject to HIPAA Compliance?
It depends on the purposes that the application is used for and the nature of its function. Suppose a company develops eHealth or mHealth software that collects personal data of the person using it for the exclusive use of that person. In that case, the application is not subject to HIPAA compliance for medical applications.
When the patient’s data is shared with medical professionals or healthcare insurance companies, then the data is considered to be Protected Health Information, and such applications should be HIPAA compliant.
There is compliance between HIPAA and medical software for personal use, in cases when an application delivers services on behalf of a Covered Entity. One of the most common examples is when a doctor asks a patient to wear a device to collect data about his health condition. HIPAA applies when medical data is later shared with the healthcare professional.
What Does HIPAA Mean for Software Development Companies?
If healthcare developers become business partners of medical providers and sign a contract with Covered Entities, they are responsible for creating all conditions for safe sharing, processing, and storing the ePHI. Companies that develop applications for the healthcare industry should ensure their apps thoroughly cover HIPAA compliance.
Companies should use a HIPAA compliance checklist to make sure their organization and healthcare software they develop incorporate the relevant technical, administrative, and physical safeguards of the HIPAA Security Rule. They must also adhere to the requirements of the HIPAA Privacy and Breach Notification Rules.
Applications for medical institutions containing ePHI should have the following features:
- Access for only authorized users;
- Automatic log off;
- Encrypted data that cannot be legible in case of cyberattacks;
- Integration with secure data storage;
- Data backup;
- Emergency mode;
- Remediation plan.
Healthcare software development companies should follow these steps to achieve HIPAA compliance:
- Conducting an initial risk analysis;
- Eliminating HIPAA compliance risks and adjusting processes;
- Ensuring long-term risk management.
All HIPAA compliant apps should be tested for secure sending attachments and images that contain PHI as well as secure messaging.