What do you have to bear in mind when developing a HIPAA compliant app? Our HIPAA-compliant app development checklist will help you ensure your app doesn’t compromise sensitive user data.
There’s a lot you need to consider when building a healthcare app. You need to make sure it loads quickly, is easy to use, and syncs up seamlessly with fitness trackers or medical software.
You also need to ensure your app complies with all data protection regulations in your country.
If you’re based in the US, HIPAA, or the Health Insurance Portability and Accountability Act, will apply to any apps you create. This federal law prevents medical data from being disclosed without the patient’s knowledge or consent.
We’ve put this guide together to developing a HIPAA-compliant mobile app. At You are launched, we have lots of experience in helping startups design, develop, and launch safe and secure healthcare and medical apps. So if you need any extra support with your custom MVP app, please get in touch!
Table of contents
- What is HIPAA?
- Does HIPAA apply If I’m not in the US?
- How much does it cost to develop a HIPAA compliant mobile app?
- Our HIPAA compliant app development checklist
What is HIPAA?
HIPAA is a US law that protects patients’ protected health information, also known as PHI.
PHI includes (but is not limited to) medical records, insurance information, and billing information, as well as any video or audio chats between patients and healthcare professionals. Essentially, PHI is anything that could potentially identify a patient.
HIPAA primarily applies to ‘covered entities’ – insurance providers, healthcare programs, hospitals, pharmacies, nursing homes, dentists, and healthcare billing services.
HIPAA also applies to ‘business associates’ – a person or organization that works on behalf of or provides services to a covered entity. So if your mobile app deals with confidential and sensitive patient information, you’re considered a business associate.
HIPAA consists of several different rules, which include:
- HIPAA privacy rule. Only one person has complete control over their medical records, and that’s the patient. PHI use must be restricted at all times
- HIPAA security rule. All relevant organizations must do everything they can to protect PHI and prevent data breaches
- HIPAA enforcement rule. Penalties apply to organizations that breach HIPAA regulations, both intentionally and accidentally
- The breach notification rule. Organizations that experience a data breach must tell patients and users as soon as possible
- The omnibus rule. The most recent addition to HIPAA, organizations are not allowed to buy and sell PHI data. This rule also extended the HIPAA guidelines to’ business associates’
Remember that you only need to be HIPAA-compliant if you handle any data that can be defined as protected health information. You don’t need to ensure compliance if you don’t handle PHI.
Does HIPAA apply If I’m not in the US?
It’s important to be aware that HIPAA applies to US citizens, rather than the US as a country. This means that if you handle the data of at least one US citizen, you have to comply with HIPAA regulations.
Even if you aren’t US-based or dealing with US citizens, you may need to adhere to similar data-protection regulations in your own country or region. For example, GDPR in Europe and the UK.
Is there a certification or accreditation I need to get to show my mobile app is HIPAA compliant?
There are some accreditations out there you can get. For example, the Health Information Trust Alliance (HITRUST) is a security framework that covers HIPAA requirements. The SOC2 audit report and ONC certification also cover HIPAA criteria.
However, you don’t need certification or accreditation to prove your mobile app is HIPAA compliant. You can say your mobile app is compliant, and as long as you’ve done the work behind the scenes to make it so, then that’s enough to keep in line with the regulations.
Conversely, accreditation or certification doesn’t necessarily prove HIPAA compliance. If you’re looking for compliant third parties to work with, you need to bear this in mind.
Do I need to assign someone to manage HIPAA for my mobile app?
Yes. All covered entities and business associates need to assign a HIPAA Compliance Officer to develop a privacy program, enforce it, and investigate any potential data breaches. In larger organizations, the work might be split into two; the HIPAA Privacy Officer and the HIPAA Security Officer.
The job can be done by anyone in your startup and doesn’t have to be a bespoke role. Your Chief Security Officer or Chief Information Officer can perform this job as part of their duties. Alternatively, you can outsource the work to a third-party provider.
It’s important to remember that HIPAA compliance is ultimately the responsibility of senior management. So, if something goes wrong, the buck stops with you and your leadership team.
How much does it cost to develop a HIPAA compliant mobile app?
It depends. While we’ve talked about how much it costs to build a mobile app before, additional safeguards need to be considered for HIPAA compliance.
The final cost of your app will depend on the type of app you want to create and how complex it is. Ensuring your app works with specific types of technology, for example, a fitness tracker can also increase the cost.
We estimate that a HIPAA-compliant mobile app will cost at least $50,000 to develop as there are additional checks and testing to take into account. However, bear in mind that you can keep costs low by building an MVP, or minimal viable product. With an MVP, you only focus on the features you know your users want to see.
While it might cost extra to ensure your mobile app is HIPAA compliant, it’s essential to consider the penalties for violating HIPAA. The most severe violations can incur a minimum penalty of $50,000, as well as a prison sentence.
Our HIPAA compliant app development checklist
As you can see, a HIPAA compliant mobile app isn’t just something that’s ‘nice to have’ – it’s essential.
So far in 2023, healthcare organizations in the US have had to pay over $270,000 in fines, and this figure is growing all the time. And there are not just finances to take into consideration; the reputation of your startup and mobile app could be at stake too.
Here’s what you need to bear in mind when it comes to HIPAA app development.
1. Lockdown access permissions
Not everyone working on your team will need to see patient data. Having the right access controls in place minimizes the risk of developers, technical product owners, and project managers seeing information they don’t need to see.
Not only this, but it reduces issues if cybercriminals try to steal any data.
As well as setting up the correct access permissions, there are other things you can do to ensure compliance. For example, having secure password policies in place, enabling automatic logout, and making sure your antivirus software is up to date.
2. Encrypt all relevant data
HIPAA requires that all PHI be encrypted when it is ‘in transit’ or ‘at rest’. This means it must be encrypted when moving from sender to destination, as well as when it is being stored on a server or drive, whether physical or in the cloud.
Encrypting data means that people or malicious software cannot intercept and access the data, as an encryption key is needed to view it.
We recommend putting your PHI in a separate database, as this can help improve the speed and performance of your mobile app.
3. Choose accredited and trustworthy software providers
Using off-the-shelf solutions can often be cheaper and faster than coding features yourself. And when you’re racing to launch your mobile app, time is of the essence.
However, it’s vital to ensure that any tech you use adheres to HIPAA regulations. While some software isn’t HIPAA compliant straight off the bat, it can sometimes be made compliant with specific configuration changes.
Any cloud providers you use to store data must be HIPAA compliant too. Ask to see their policies to see what they do to protect documents and files.
4. Select the right app features
Choosing the right features for your app can make the difference between launching successfully and having to go back to the drawing board.
When building a HIPAA compliant mobile app, you need to select the features that are most likely to protect user data and prevent people from accessing information that’s not theirs. Some features you might want to consider include:
- Two-factor or multi-factor authentication
- An automatic logout feature
You may also want to consider ’emergency mode’. This enables a doctor or healthcare provider to quickly access someone’s medical data in an emergency situation. However, most mobile phones now have medical information settings, so your market research may identify that this is not an essential feature.
5. Back up your data
You need to back up your data on a regular basis. That way, you can restore lost data and ensure people can still access their personal information.
Ideally, you should have policies in place for backing up your PHI and store any backups in a secure, encrypted facility. You should also review and audit your storage systems periodically to make sure they are working correctly.
Good data hygiene is also important. You should remove old data and duplicate records. However, remember that unlike GDPR, there is no ‘right to be forgotten,’ so you can’t delete records permanently, even if a patient requests it.
6. Test your app before it launches
It’s essential to thoroughly test your app before it goes live in order to catch any significant bugs and issues. With HIPAA compliant mobile app development, it’s worth asking an external and independent agency or auditor to check out your code.
They will be able to review your app with a fresh pair of eyes and identify anything that might cause a potential HIPAA breach.
7. Train your team
As well as having a well-encrypted app, you need to train your team on HIPAA law. You need to advise them on what type of information is included in the regulations, and what they can and can’t do.
For example, one of the most common HIPAA violations is looking at people’s healthcare records. Therefore, it’s important to remind your team that they can’t access people’s medical details and can be held personally liable for mishandling information.
8. Keep checking your app
You might think that the hard work is done when your app is launched to the public.
However, it’s still important to review and monitor your mobile app. Updates, new features, and data sharing with third parties can cause potential issues and risks.
While the HIPAA regulations have not been amended since the introduction of the omnibus rule in 2013, it’s critical to keep up to date with any updates. Alterations to the regulations may mean you have to quickly make changes to how your app works.
You need to keep records of all PHI-related activities for six years, including app login attempts. This can help you quickly identify any potential issues and attempts to gain access to sensitive data.
HIPAA stands for the Health Insurance Portability and Accountability Act, a US federal law that protects patients’ protected health information (PHI). PHI includes medical records, insurance information, billing data, and any other information that could identify a patient.
Yes, HIPAA applies to any entity that handles the data of at least one US citizen, regardless of their location. If you deal with PHI of US citizens, you must comply with HIPAA regulations. Other countries and regions may have similar data protection regulations, such as GDPR in Europe and the UK.
While there are accreditations like HITRUST, SOC2, and ONC certifications that cover HIPAA requirements, certification is not mandatory to prove HIPAA compliance. If you’ve implemented the necessary measures and safeguards, you can claim compliance. However, certification can provide additional assurance.
Yes, it’s essential to designate a HIPAA Compliance Officer responsible for developing, enforcing, and investigating potential data breaches related to PHI. In larger organizations, this role may be split into a HIPAA Privacy Officer and a HIPAA Security Officer.
The cost depends on factors like the app’s complexity and features. Developing a HIPAA-compliant app typically costs at least $50,000 due to additional checks and testing required. However, building a minimal viable product (MVP) can help reduce initial costs.
The checklist includes several critical steps:
– Lockdown access permissions.
– Encrypt all relevant data.
– Choose accredited and trustworthy software providers.
– Select the right app features.
– Back up your data.
– Test your app before it launches.
– Train your team on HIPAA compliance.
– Continuously monitor and update your app to stay compliant.
Unlike GDPR, HIPAA does not include a “right to be forgotten.” You cannot permanently delete patient records, even if a patient requests it. However, you should implement good data hygiene practices and remove old data and duplicate records when necessary.
Violating HIPAA regulations can result in severe penalties, including fines starting at $50,000 and potential legal action. It’s crucial to take HIPAA compliance seriously to avoid such consequences.
We hope you found this HIPAA-compliant app development checklist helpful. Don’t forget; if you need help developing a HIPAA-compliant app, we have the experience you need to see success.