HIPAA-Compliant Software Development Checklist for 2023
HIPAA is a well-known concept in the context of the improvement of data privacy and data security in the healthcare industry. As HIPAA introduced critical changes to how organizations may store, handle and use sensitive patient information, it covers healthcare providers, health plans, and business associates of HIPAA-covered organizations.
Whether you want to make your existing healthcare product HIPAA-complaint or create a new top-notch app or website with HIPAA requirements in mind, our guide includes insights and unique tips from our multi-year HIPAA experience and will help you understand what you should pay attention to while working on your project.
We, at MobiDev, want to ensure that you know how to make your web or mobile healthcare application compliant with HIPAA rules so data breaches do not happen to you and your customers. You can download the short version of HIPAA Compliant Software Development Checklist for 2023 above for free.
How to Develop HIPAA-Compliant Web or Mobile Healthcare Apps
The means for making your medical software HIPAA-compliant or building one from scratch depends on your goals and the way sensitive data is stored and transmitted. However, let’s talk about seven general thoughts on how these requirements need to be met.
Any ePHI (electronic Protected Health Information) must be encrypted before being transmitted. HIPAA-compliant software keeps sensitive health data encrypted during transmissions and the first step is to make it secure with SSL and HTTPS protocols. Your public or private cloud provider should allow for the configuration of your SSL to ensure strong encryption methods according to the HIPAA-compliant hosting checklist. The former protects pages that collect or show health data as well as login pages. There should not be any alternate non-secure versions of these pages.
It’s recommended to validate if the HTTPS protocol is set up properly and if there are no expired or insecure TLS versions.
Passwords can be transmitted and stored with the help of hash values. Together with secure complex passwords, this can prevent compromising events. Here is the specific information about HIPAA compliance of WordPress-based websites.
2. BACKUP AND STORAGE ENCRYPTION
Most hosting providers offer backup and recovery services so that data will not be lost in case of an accident or emergency. Data should be backed up, stored securely, and accessible to authorized staff only.
When dealing with sensitive PHI, one must ensure that it is available to authorized personnel only. This covers all the data stored in your software system, including databases, backups, and even logs. It may be stored in locations that are out of your control, such as on a server shared with other customers on the same hosting provider. Should this server be compromised in some way, the data must remain encrypted and inaccessible.
For this purpose, we apply industry-approved encryption using AES and RSA algorithms with strong keys (preferably 256 bits for AES, and at least 4096 bits for RSA). A PostgreSQL manager with a built-in data encryption feature could be an alternative solution.
We also use managed databases in the public cloud with encryption, for example, Amazon Relational Database Service (RDS) or Cloud SQL in the Google Cloud Platform.
3. IDENTITY AND ACCESS MANAGEMENT
In order to maintain HIPAA compliance, identity, and access management are essential. When it comes to institutional data, passwords, and user IDs, they must be as secure as possible and never shared among employees. HIPAA has very strict rules about the level of security that must be maintained to ensure user data privacy and protection.
System logs are an important part of HIPAA compliance. The system should write access logs and event logs, to track all the login attempts and changes made to PHI.
To ensure that only authorized users are able to access sensitive data and information, Two Factor Authentication (2FA) should be used, using multiple forms of authentication to verify an individual’s identity.
However, there is a demand to access this data quickly. In order to remain secure while providing data on demand, new technologies are rising in the healthcare industry like biometrics and single sign-on (SSO).
Single-Sign On enables users to securely sign in once and then access a network of applications and websites during a single session without having to sign in again. This is useful for healthcare professionals who need to gain access to user data across an ecosystem of apps and sites quickly and efficiently without sacrificing the privacy of institutional data.
Biometrics authentication solutions are also popular because of the uniqueness of the human fingerprint, face, or voice. However, these technologies require advanced anti-spoofing techniques. To prevent hackers from simulating the biometrics of another person, liveness detection can counteract spoofing attempts. Multimodal biometric authentication technology requires more than one form of authentication. This can make it even harder for hackers to crack healthcare security and helps better ensure HIPAA compliance.
Attribute Based Access Control is a way of resolving complications with user role management. This allows for dynamic and contextual access to various locations, apps, and other resources according to access control policies based on attributes instead of users and actions. Individual attributes are much more flexible, especially for changing structural rules over time. This especially helps resolve problems in traditional role-based authorization where roles overlap.
It is absolutely necessary to ensure that the information you collect, store, and transfer is safely kept from being damaged or altered in any undesirable way, intentionally or not. The first necessary step here is to make sure that your system is able to immediately detect and report any unauthorized data tampering, even if just a single element has changed. In website development, this is achieved by digitally signing and then verifying every piece of data stored or transmitted in the system, using such means as PGP, SSL, etc. Then, the entire system has to be designed and built in a way that prevents any unauthorized access to the data.
The measures mentioned above, like regular backup, encryption, access authorization with proper user roles and privileges, as well as restriction of physical access to the infrastructure, are a big factor in making your medical software HIPAA-compliant.
Backed-up and archived data has to expire and be permanently disposed of. This also applies to all the decryption keys. It must be foreseen that every location where the data is transmitted might be making backups or copying it. Whenever you are no longer using a server, the data must be disposed of as well to ensure healthcare data security and HIPAA compliance.
6. BUSINESS ASSOCIATE AGREEMENT
The final key to HIPAA-compliant software: ePHI should be hosted on servers of a company with whom a Business Associate Agreement is signed. Otherwise, it should be hosted on secure in-house servers. Most hosting providers are not familiar with HIPAA. They might not be willing to run any risks signing this agreement, which might contradict their own business processes.
We recommend a healthcare organization to use cloud storage at the most trusted HIPAA-compliant providers*, such as:
* !! Please be aware that Apple’s iCloud is not HIPAA-compliant !!
Business Associate Agreement must concern every vendor that deals with your sensitive health data.
Our Case Studies for HIPAA-Compliant App Development
CASE#1. CROSS-PLATFORM MANAGEMENT SOLUTION FOR A US-BASED HEALTHCARE ENTERPRISE
MobiDev’s team was asked to create a cross-platform healthcare mobile and web application. The objective was to integrate patient-doctor interactions and allow them to exchange data. To do this, our team found a balance between speed and compatibility using native-like features, HealthKit/GoogleHealth integrations, live chat, and more. Being a complex app, it allowed for the analysis and management of information on a large scale useful for hospitals. This enabled it to be integrated with EHR.
The app was needed to fulfill two primary functions: a portal for patients and doctors and a management and analytics module, as well as hospital-level integration. To help achieve this goal, the client’s in-house team was involved with the development of integrations and database management.
While our team worked on a test and anonymized data, the client’s team worked on bridging and provided MobiDev with the data structure. Synchronization between our teams was essential in order to create a reliable solution that would work with different Electronic Health Records (EHR).
Amazon Cloud Services (HIPAA compliant) were utilized in order to make the app reliable and secure. Although it was useful in this case, some hospitals are more interested in using local servers for data storage and operation. We worked with their support teams to ensure that the app fits their needs. In order to secure the data on Amazon’s web servers, our team utilized encrypted RDS.
In addition, data transportation and event management needed protection. MobiDev’s team utilized Encrypted ElastiCache to respond to this problem. Also, front-end security features were added such as cache restrictions for browsers. This prevents users from saving cached images of X-ray scans.
Search history was also restricted for browsers to prevent personal patient data from being saved like names and emails. Oauth2 and JSON Web Token (JWT) were also used to protect user authentication.
CASE#2. MEDICAL SEARCH ENGINE APPLICATION
The Client expected to create the app, which is a medical search engine for patients based on a database of medical content and a website. This app is aimed to simplify fast searches on the go and convenient offline access within an intuitive and highly responsive application.
In cooperation with the client, we’ve made a decision to build a native iOS app, and then proceed to Android as a separate project.
When it comes to medical apps and legally protected HIPAA-compliant software development, the quality of software products and information security are even more important. The client’s product must provide relevant and accurate information to users and must do so in a reliable and fast manner. The risks of a user failing to find and access the needed information must be minimized. We managed to build such a product and publish it on the App Store within the expected timeframe, much to the client’s satisfaction.
The project was developed as a simple method for healthcare professionals and patients to access the most relevant medical information from a wide range of sources. Among the applied technologies were: CoreData, AFNetworking, Custom View Controls from Cocoa Controls, ViewDeckController, and JSONModel.
Case study:MEDICAL SEARCH ENGINE APP DEVELOPMENT
CASE#3. CLOUD PLATFORM FOR GROUP THERAPY AND WELLNESS
The project has aim to help people find a way to improve their well-being through evidence-based treatment, connection, support, and validation. The app provides group therapy – treatment for both mental and social health and a modality of behavioral healthcare proven as effective as individual therapy. The MobiDev team was asked to take part in the project.
Tracking a member’s behavioral health symptoms was among the key features to be delivered, so we developed a comprehensive measurement, monitoring, and analytics system for the app. The profound logic we’ve implemented provides in-depth analytics represented in an easy-to-get format.
As the app processes and stores personal health data, so taking HIPAA requirements into account was extremely important. Collaborative work with the client’s in-house team allowed us to reach this goal.
We created a development strategy that combined open-source tools and libraries with custom development to optimize timelines and costs. Calendar, video chat, and UX were all leveraged from easily available market solutions.
Since engaging both members and clinicians was core to the platform design, we’ve thoroughly worked on UX & UI design to make an app easy to use, especially for new customers.
Among the applied technologies were: NodeJS, NestJS, PostgreSQL, RDS, ReactJS, Ant design library, React Admin, Recharts.JS, AWS, Stripe payment integration, Google Calendar API, Amazon S3, Amazon SES, Agile management framework.
Case study:CLOUD PLATFORM FOR GROUP THERAPY AND WELLNESS
The Bottom Line
HIPAA compliance is essential in order to protect institutional healthcare data and avoid steep regulatory fees. It’s better to get ahead of the game and design systems with HIPAA requirements in mind. As you can see from our cases, MobiDev has extensive experience on how to develop HIPAA-compliant projects of a wide range. If you are thinking about creating a HIPAA-compliant healthcare app/site or improving the existing project, we would be glad to help as we have top-notch technology expertise that allows us to meet the most complex business needs.