HIPAA-Compliant Checklist for Software Development [Ultimate Guide 2023]

The Health Insurance Portability and Accountability Act (HIPAA) is one of the most important regulations that healthcare software developers must follow. This law safeguards personal health information. Anyone who operates or invests in medical businesses is aware of it, but failure to follow its rules correctly can result in severe penalties. HIPAA information privacy breaches resulted in millions of dollars in fines last year.

The global healthcare software market is expected to reach 55.15 billion pounds by 2025, growing at a CAGR of 13%. Gartner forecasts a 43.9% CAGR in the mobile health (mHealth) market by 2027. Significant growth will be seen in areas such as telemedicine, augmented and virtual reality, artificial intelligence, wearable technology, and the Internet of Medical Things, driven in part by the COVID-19 pandemic – all of which are poised to either improve patient health, aid in medical discoveries, or reduce healthcare costs.

What kind of entity will make use of the application?

The covered entity (healthcare provider, health plan, healthcare clearinghouse) or business associate is responsible for HIPAA compliance (any associate who has access to PHI).

What kind of data will the app use, share, or store?

During their use, healthcare apps that intend to store, record, or share PHI will be subject to HIPAA regulations. Any identifiable data about the patient, such as name, address, date of birth, SSN, device identifiers, email addresses, biometric, lab or imaging results, medical history, and payment information, is considered protected health information (PHI) or electronically protected health information (ePHI).

How to Create HIPAA-Compliant Web or Mobile Healthcare Applications?

The method for making your medical software HIPAA-compliant or building one from scratch is determined by your goals and the manner in which sensitive data is stored and transmitted. However, let us discuss seven broad ideas about how these requirements must be met.

1. Storage and Backup Encryption

The majority of hosting companies provide backup and recovery services to ensure that data is not lost in the event of an accident or emergency. Data should be backed up, securely stored, and only authorized personnel should have access to it. It is critical to ensure that it is only accessible to authorized personnel when dealing with sensitive PHI.

This includes all data stored in your software system, such as databases, backups, and logs. It may be stored in places beyond your control, such as a server shared with other customers on the same hosting provider. If this server is hacked in any way, the data must remain encrypted and inaccessible.

2. Transport Encryption

Before being transmitted, any ePHI (electronic Protected Health Information) must be encrypted. HIPAA-compliant software encrypts sensitive health data during transmission, and the first step is to secure it using SSL and HTTPS protocols. According to the HIPAA-compliant hosting checklist, your public or private cloud provider should allow you to configure your SSL to ensure strong encryption methods. The former safeguards pages that collect or display health information, as well as login pages. There should be no non-secure variations of these pages.

It is recommended to validate that the HTTPS protocol is properly configured and that there are no expired or insecure TLS versions. Passwords can be transmitted and stored using hash values. This, in conjunction with secure complex passwords, can help to prevent compromising events. Here is more information about HIPAA compliance for WordPress-powered websites.

3. Identity and Access Management

Identity and access management are critical for HIPAA compliance., User accounts and passwords must be as secure as possible and never shared among employees when it comes to institutional data. HIPAA has established tight rules and guidelines regarding the extent of security that must be maintained to ensure user data protection and privacy.

System logs are an essential component of HIPAA compliance. To track all login attempts and changes to PHI, the system should generate access logs and event logs. Two Factor Authentication (2FA) should be used, using multiple forms of authentication to verify an individual’s identity to ensure the access of only authorized users to sensitive information and data.

4. Disposal

Data that has been backed up and archived must expire and be permanently disposed of. This holds true for all decryption keys. It must be anticipated that backups or copies of the data will be made at each location where it is transmitted. To ensure healthcare data security and HIPAA compliance, data must be disposed of whenever a server is no longer in use.

5. Integrity

It is critical to ensure that the information you collect, store, and transfer is not damaged or altered in any way, whether intentionally or unintentionally. The first step is to ensure that your system is capable of detecting and reporting any unauthorized data tampering, even if only a single element has changed.

This is accomplished in website development by digitally signing and then verifying every piece of data stored or transmitted in the system using tools such as PGP, SSL, and others. The entire system must then be designed and built in such a way that unauthorized access to the data is prevented. Regular backup, encryption, access authorization with proper user roles and privileges, and physical access restriction to the infrastructure are all important factors in making your medical software HIPAA compliant.

6. Business Associate Agreement

The final piece of the HIPAA-compliant software puzzle: ePHI should be hosted on the servers of a company that has signed a Business Associate Agreement. Otherwise, it should be hosted on private, secure servers in-house.

The majority of hosting providers are unfamiliar with HIPAA. They may be unwilling to take any chances by signing this agreement, which may contradict their own business processes. It is recommended that a healthcare provider should use cloud storage which is the most trusted HIPAA-compliant provider such as Google Cloud Platform, Microsoft Azure, and Amazon Web Services.

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