While medical providers are looking for ways to accommodate healthcare consumerization, the market of digital solutions for this sector keeps growing incessantly. It was valued at $153 billion in 2022, and it’s anticipated to grow with a CAGR of 16% by 2027.
Since many companies invest in technologies to address patient needs and stay ahead of competitors, they should be aware of rules and regulations their software has to follow. No doubts that HIPAA is one of the most important requirements to meet when developing a health app.
So what does mobile app HIPAA compliance mean? What does it take to achieve it, and how much do its violations cost? Let’s find out the basics and explore the considerations to take into account while initiating HIPAA-compliant app development.
What Is HIPAA?
Health Insurance Portability and Accountability Act, or HIPAA, is a US statute introduced in 1996 that regulates the flow of healthcare data. Part of this act specifies how personal information processed by healthcare and insurance companies should be protected from fraud and theft.
Among all the rules incorporated in HIPAA, you should pay close attention to five of them. They are:
- Privacy Rule
- Security Rule
- Enforcement Rule
- Omnibus Rule
- Breach Notification Rule
The need for your medical software to be HIPAA-compliant is defined by the type of entity that uses the app and the type of data covered by it. To give you more details, we’ll take a look at each of these criteria.
While thinking about health application development, you need to distinguish two types of data in order for your solution to be HIPAA-compliant. They are Consumer Health Information, or CHI, and Protected Health Information, or PHI.
HIPAA is applicable whenever software processes PHI. It’s a set of data that’s generated during medical treatment or diagnosis and shared with a covered entity. It also encompasses the information that identifies an individual.
Commonly, PHI includes:
- Personal information
- Medical information
- Payment details
When an app handles personal and medical data, it falls under HIPAA regulation. For example, if the application helps study skin diseases by analyzing anonymous images, it doesn’t have to be HIPAA compliant. However, if the same app monitors images that contain sensitive data like names, addresses, phone numbers, etc. — HIPAA comes into force.
So what about CHI then? CHI is any health related data that’s not shared with covered entities. For example, if you work on the web or mobile application that monitors and processes metrics like heart rate, blood pressure, or breathing but doesn’t transmit them — it doesn’t have to be HIPAA-compliant.
HIPAA regulations apply to all entities that access, produce, process, and store PHI. According to the Privacy Rule, there are two types of entities subjected to it: covered entities and business associates.
Covered entities refer to all healthcare organizations, providers, clearinghouses, and private practices. This type of entity also incorporates pharmacies, nursing homes, and insurers.
Business associates are organizations that collect, store, and handle PHI on behalf of the covered entities. They can include software and cloud service providers, lawyers, or accountants.
Why Is HIPAA Important?
HIPAA plays a vital role for both patients and healthcare organizations. It was enacted to help protect sensitive data and ensure that its processing and sharing are strictly regulated. The act provides important rules related to confidentiality and privacy, defines what parties can share information, to whom and how it can be disclosed.
Therefore, any company considering design and development of an app that deals with health data, whether it is a web or mobile solution, should clearly comprehend if it has to be HIPAA compliant.
Apparently, yet often arguably, HIPAA provides the greatest benefits for patients. Most Americans have heard of it but not many understand why it’s so important. There are four main aspects of HIPAA that patients should be aware of in order to know the rights and protections applied.
Here they are:
- Privacy of health data
- Security of medical information
- Notification of data breaches
- The right to obtain copies of medical records
For Healthcare Providers
On the other hand, HIPAA dictates a number of rules to follow for medical organizations to ensure PHI protection as well improve the administration of healthcare. Majorly, these rules protect data from theft. In accordance with them, PHI cannot be forwarded without patients’ consent and, if any breach appears, entities must notify patients.
Obviously, many custom healthcare software development projects should pay respect to HIPAA compliance as, in case of violations, there’s a high chance of penalties.
Risks and Penalties
Where is a rule, there can be a violation; and where is a violation, there can be a penalty. It’s hard to underestimate HIPAA compliance software requirements and the importance of an app to follow them, so it’s better to be prepared and know what to expect in case of noncompliance.
Examples of major violations of HIPAA rules include the loss of data, accessing confidential information, or sharing PHI without authorization. The size of fines levied on entities varies from $100 to $50,000 per violation and can reach an annual maximum of $1.5 million.
With that in mind, let’s go further and explore the key tips to build a healthcare mobile app compliant with HIPAA regulations.
Key Features of HIPAA-Compliant Applications
Every healthcare software development project is definitely unique and requires a tailored approach. However, in case with building HIPAA-compliant mobile apps, there are several essential features to incorporate. In particular, they include:
- Authorization. Enable easy login for users but stay focused on ensuring security. One of the ways to consider here is implementing a one-time password for authentication.
- Emergency access. Given various emergency cases from network conditions to services disruptions, there should be a way envisaged and taken into account to provide a consistent access to the app.
- Encryption. It’s an important part for software vendors delivering apps that are subject to HIPAA compliance. We’ll take a closer look at this matter further on.
Tips to Build a HIPAA-Compliant App
While working on your health software solution, the Security Rule is the one to focus on in the first place. It lays out three types of security safeguards to adhere to — administrative, physical, and technical. Each of them consists of standards and specifications that dictate your development team how to make an app HIPAA-compliant.
Here, we’ve summoned up the main steps to include in your medical app development process.
1. Limit Access to the App
To protect PHI from identity theft and unauthorized access, consider the implementation of the authentication process. It can be necessary to think about user roles with certain access rights as not every participant on the provider’s side needs to interact with all PHI details. Here, you can think of hospital management software that must be HIPAA-compliant but has too many people involved in working with sensitive data.
There are many ways to limit access to the app. For example, you can think about biometric or certificate-based authentication or apply multi-factor authentication that requires two or more ways to identify a user. Another effective method is to automatically log off idle users.
Learn how the Implementation of Two-User Roles Restricted Access to Mobile Medical Surveillance App
2. Ensure Data Integrity
Data integrity is extremely important for building HIPAA-compliant mobile apps and otheк software solutions. The use of encryption technologies and secure communication channels allows health apps to protect sensitive data. They ensure that, even if a breach occurs, confidential information is safe because it can’t be decoded and read.
In addition to applying secure HTTPS connection and SSL/TLS protocols, it’s vital to transfer PHI following Healthcare Messaging Standards like HL7, FHIR, CDA, DICOM, etc. Keep in mind that data should be protected during both storage and transfer.
3. Implement an Audit Mechanism
Together with the security measures mentioned above, your medical app should control suspicious activities. Besides, it should track what users interact with an app and how they do it.
In order to achieve this, developers need to implement an audit procedure and create activity logs. It will enable recording and examining processes that involve the use of PHI.
4. Remove PHI from Push Notifications
As one of the features of your medical app, you may want to incorporate push notifications. In this case, consider excluding PHI from them. Even when the phone is locked, the data may appear on the screen and be visible publicly.
Similarly, don’t mention any sensitive data in messages or emails unless consent is given by a user. It might happen that not all communication channels are encrypted, thus medical and other personal information can be easily compromised.
Reach HIPAA Compliance with the Right Expertise
Besides having an idea and a development strategy for your healthcare solution, it’s fundamental to ensure you meet the requirements of mobile app HIPAA compliance. Primarily, focus on the security measures to protect PHI and provide data integrity.
HIPAA regulations often pose a challenge for software developers and require some effort to understand and follow them to the letter. However, misreading or ignoring them significant risks and penalties. Thus, when you request for custom software development services, choose a team of developers that already knows what HIPAA compliance means and can help you build a application in accordance with these rules and your goals.
Velvetech has rich experience in healthcare app delivery that’s reinforced with profound knowledge of the field. The company’s technology expertise will support you in the development of robust eHealth software, compliant with all essential aspects of HIPAA. Reach out to us today.