Any businesses or enterprises like hospitals, clinics, and insurance companies or even healthcare app developers that work with PHI should only adopt HIPAA Compliance Software Development.
So, what do you remember of the year 1996? I recall Steve Jobs being called back from his 11 years of exile to rescue Apple, Google was still developing its legendary search engine, and JAVA was still at version 1. But most importantly I remember Bill Clinton signing the Health Insurance Portability and Accountability Act, also known as HIPAA.
You must be scratching your head to understand what HIPAA is? It is a federal act mandated across America for any business or organization that offers IT-based services and solutions in healthcare verticals.
Still Confused? Let’s imagine a scenario that will reveal the purpose of HIPAA.
What Happens If Your Medical Data Gets Stolen?
What do you do if your email ID is hacked due to a data leak from one of your mobile apps? Probably, you’ll notify all your contacts and create a new ID. Well, that is fine because you can change that bit of information about yourself at any given moment.
But, what about your blood group, your allergies, your last year’s medical expense records? You can’t change that information, and what if this information goes into the wrong hands? Then your health life is at risk to be exposed and exploited by anyone.
The question here is that who will be liable in case of such information loss? Who will be responsible if there is a data breach to the user’s personal medical information? The company, government, the vendor, the cloud server? Who will be brought to the court and be held accountable to answer?
These questions and the fear of being hacked was the reason the thought to create a nationwide act to protect the medical data of patients and health-care seekers came into existence. So, HIPAA is basically the single line of defense against any type of cyber attack on a medical application, software or portal that holds health information.
What Is HIPPA?
HIPAA has 4 Main Purposes
- A) Privacy of Health Information
- C) Administrative Simplification
- B) Security of Electronic Records
- D) Insurance Portability
What we are concerned with in this blog are points A and B. As the title suggests, you are here to learn how to build HIPAA compliant apps, software, and devices that comply with HIPAA guidelines and regulations.
So the developers and entrepreneurs planning to develop medical and health-related digital solutions should be concerned with the data privacy that is created, stored, and transmitted via your software.
You can’t understand HIPAA without the understanding of PHI (Protected Health Information).
What is PHI?
PHI (Protected Health Information) is any information about health care, medical status, and payment information for any healthcare that is created, stored, or transferred by a Covered Entity or a Business Associate that can be linked to an individual who sought the medical care.
Who Are Covered Entities Under HIPAA?
According to HIPAA, a Covered Entity is anyone who
- A) Provides Health Plans
- C) Healthcare Providers (who use medical software and app to transmit PHI)
- B) Healthcare Institutes
Who Are Business Associates Under HIPAA
Business Associates under HIPAA are anyone who collects, stores, or transmits PHI for a covered entity.
How to become HIPAA-Compliant Enterprise?
It is easier than you think. The key to become and stay HIPAA compliant is consistency. While you are developing your healthcare app or software make sure that you completely follow the technical guidelines mentioned in the act.
The technical guidelines cover the software part of the solution like activity logs, data encryption, app login, emergency access, etc. while the physical guidelines comprise the security of the data center, servers, and other hardware that work on the backend of the solution.
What are the features required in HIPAA Complaint mobile app? Let’s get familiarized.
HIPAA Compliant Feature Lists
Proper Access Control
The App needs to have a properly defined access control for its users and admins. The amount of access to the data should be restricted according to HIPAA privacy rules.
Proper user authentication methods like Biometrics, Password, PIN code, or card/token should be set in your HIPAA compliance software development.
If your device or software will be transferring PHI over a network, then you must make sure the data transmitting over the network is encrypted with SSL/TLS.
Permanently destroy any PHI that is not useful anymore. In many instances, companies lost a fortune over such data that wasn’t even being used. You will learn more about PHI disposal later in the blog.
Secure Data Backup
Data backup is necessary for any company, let alone the one dealing with important PHI. To stay secure against server crash and database corruption or even natural accidents like earthquake or fire outbreak, have secure data backups.
Responsible Audit Control
Have a responsible audit control set up for the PHI data being handled. The company must always know where and how the PHI is being accessed and used. A simple approach is to have a log file in the database of who is accessing which PHI data at a given time.
Besides the app or software you must also consider the device security. By adding features like full device encryption and remote data erasure, you add a more secure layer to the medical app.
Why Should You Care About HIPAA Compliance For Web Applications Development?
Well, HIPAA is the government regulatory body whose work is to make sure that you create healthcare apps or software that is safe to use for people and is a robust solution against any cyber attack.
You need to understand that HIPAA is not a body that protects you in case of any misfortunate cyber attack. This act is only there to protect the PHI of patients and make sure that your digital health solution is safe from such attacks in the first place.
So you can’t just market your app built under PHI guidelines without complying with HIPAA. This way you are already violating the regulation. If you are the entity that owns that software or the one that built the medical software, you are legally obligated towards the app users.
So the Covered Entities and Business Associates, both are liable under the HIPAA act.
Let me repeat it one last time to clear out any doubts; if you build a healthcare or medical app, software, device, or portal that creates, stores, maintains, and transmit PHI, you should go for HIPAA compliance software development.
A 10 Point Checklist To Create HIPAA Compliant mHealth Apps & Software
Understand these 10 commandments to follow when creating HIPAA compliant mobile apps. By implementing these pointers, you can build the best Mhealth apps for your target audience with complete compliance with HIPAA for PHI.
1. Do you need HIPAA?
Make sure whether your app actually needs HIPAA compliance. For instance, if all your software is collecting is calorie intake or blood pressure and heart rate, for instance, a fitness band, then your fitness and health startup app doesn’t need a HIPAA compliance.
2. Collect Only Necessary Data
Only access the information that is useful for your needs. For example, If your software needs to just learn about the medical stats of the patients then recording their medical expenses is of no use to you and simply a larger threat in case of a cyber attack.
3. Sign a BAA
Always sign a Business Associate Agreement (BAA) when you have to involve 3rd party vendors. This way even if your team is perfect in maintaining security, if a slip occurs on the vendor side, the BAA will protect you from the damage done by other parties and vice versa.
4. Keep Data Encrypted
Always keep HIPAA compliant text messaging data encrypted. To clarify, SMS and MMS are not encrypted, so don’t add these features to your medical app. Similarly, push notifications are a big no-no for such apps.
6. Choose HIPAA Compliant Cloud Stack
Go for HIPAA compliant cloud stack for healthcare and don’t store data on the Android or iOS devices. A human error can occur anytime. Leaving the device open or losing the device can put such data on a threat.
7. Dispose the Data Not Needed
Dise of the PHI that is not being used. If you clear out the information that is no longer needed, you will not be in any risk as that information won’t be anywhere to access or hack.
8. Choose the Right Development Partner
Always hire a mobile app development service company that has experience in HIPAA compliant software development. Such a team of experts will not just build the app according to HIPAA compliance but also test the app properly for every possible threat with static and dynamic app security testing.
9. Balance User Accessibility with Data Protection
You need to make a good balance between user accessibility and data protection making the app interface both safe as well as easy for the users to work with. Features like Two-Factor login, and timeout the local session in the app would comply with HIPAA as well as prove to the app users the security of your health app.
10. Find a Professional Business Analyst
Double Check the HIPAA regulations and take advice from a professional Business Analyst who can explain to you how important is HIPAA and PHI regulations for your app and what would be the cost to get the certification.
What Are The Fines If You Violate HIPAA?
After learning all this, you may think “Is going through all this trouble worth it?”. There are two responses to this question.
You should go for HIPAA compliant app development as this certification creates a powerful brand image in the eyes of medical professionals and every healthcare provider and seeker. As a result, you’ll be among the top 1% of apps that have HIPAA compliance hence the most trustworthy software solution.
There is another reason to go for HIPAA compliant software development. That is to say, if you do not do so and there is a breach attack, and PHI is leaked from your software or mobile health application; You will be responsible and liable to pay fines as per the court orders. Further, the Civil Penalty ranges from $100 to $50,000 per violation per user.
So if there is a breach of about 500 user data, and if the court charges you a $1000 fine per user (if the data was not very precious) then you will end up paying $500,000 for such a case.
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What Will Be Your HIPAA Compliance Software Development Choice?
HIPAA is not the only regulatory body for healthcare app and software development. Entities like FDA, EPCS, HL7, and GDPR that provide certification for companies.
HIPAA can seem to be a tough and confusing body that you can’t fathom alone. So you need a team of expert medical app and software developers that have worked with HIPAA before. With such an expert development company you can create your own HIPAA complaint mobile healthcare app with ease.