If you’re stepping into the world of the healthcare industry or thinking of launching a secure healthcare mobile app, you must know about HIPAA. This comprehensive guide covers everything crucial you need to know about HIPAA compliance for healthcare app development.
The healthcare industry has always been one of the thriving industries and the strongest pillars of the world economy. This sector has indeed gained immense technological acceptance globally in no time and still continues to boom at an unprecedented pace.
At the same time, the industry experienced more lift amid the COVID-19 pandemic. Many healthcare app solutions have come up in the wake of Coronavirus. In fact, research shows, COVID-19 has led to a 25% increase in healthcare app downloads.
That means healthcare application development is steadily on the rise, and this trend is not slowing down anytime soon. As the healthcare industry is getting more and more competitive day by day, businesses (that want to invest in healthcare apps) are also looking for various ways to stay ahead in the game.
However, with an increasing number of healthcare apps hitting the market, data breaches and security threats also continue to grow in the health industry. Per Businesswire, healthcare data breaches affected 26.4 million records in the US alone in 2020.
Hence, to ensure that security is not compromised, companies are focusing more on protecting medical data with utmost care. How? By complying with the Health Insurance Portability and Accountability Act (HIPAA).
What Is HIPAA Compliance?
Before we proceed any further, we must learn about HIPAA first. Why? Because as a mobile applications development company, one of the most commonly asked questions we get is, “What is HIPAA compliance?” So let’s dive in and learn about it!
HIPAA is an excellent initiative of creating standards and protocols followed, regulated by the Department of Health and Human Services (HHS) and enforced by the Office for Civil Rights (OCR) to protect and secure Protected Health Information (PHI) prescribed by the Health Insurance Portability and Accountability Act of 1996 (aka HIPAA).
In other (and simpler) words, HIPAA compliance refers to meeting the requirements of the HIPAA act, regulated by the US Department of Health and Human Services (HHS).
Types of Healthcare Data Domains
- Protected Health Information (PHI) – PHI comprises every aspect of patient information. This information is used, stored, maintained, and shared by entities that come under this act. If you build a HIPAA-compliant healthcare app, it should run and operate as per PHI guidelines only.
- Consumer Health Information (CHI) – CHI is any data that doesn’t get shared with a covered entity. These can track different health metrics, but that data isn’t considered PHI or sent to the covered entity. To understand CHI better, think of health-based apps like FitBit and Google Health. You don’t need to worry about HIPAA in this case.
The Importance of HIPAA Compliance in Healthcare Apps
Let’s admit that technology is not immune to abuse. Your smartphones can be hacked, and unauthorized access to sensitive information is always a possibility.
And keeping health-related data secure is more crucial than ever these days. Consequently, HIPAA enters the game to protect it.
- Data privacy,
- Healthcare data security,
- Risk-free data transmission between care providers, health plans, and other entities,
- Notification of healthcare records breaches.
However, the essential ones all boil down to data security. HIPAA aims to ensure complete privacy and confidentiality; thus, reducing fraudulent activity. That said, HIPAA has helped to enhance efficiency and streamline regulatory healthcare functions.
How To Know If Your App Should Be HIPAA Compliant
This question usually runs through a person’s mind who is thinking of developing a healthcare mobile app or already owns one. This question not only makes them anxious but also confuses them.
Well, don’t fret! We are here to help you with this.
When Should You Build a HIPAA-Compliant App?
If your healthcare app records, stores, manages and shares users’ personal health information, your medical app needs to be HIPAA compliant. All in all, if your app shares patients’ personal health-related information with doctors or so, in that case, it comes under PHI.
When You Don’t Need to Implement HIPAA in Your App?
If your healthcare app only collects data that is not individually identifiable and if information stays within the app, you don’t need HIPAA. That said, the apps that collect body stats, calorie count, and other health information but no personal identifiers don’t fall under HIPAA. Nike Fuelband, Google Fit, and other fitness tracking apps are good examples of the same.
Why Must a Healthcare App Be HIPAA Compliant?
Today, data is the biggest asset for any industry vertical, and the healthcare sector is even more pivotal when it comes to data. That being said, the medical data handled by apps are vulnerable to security and privacy threats.
To protect this data, healthcare apps need to follow HIPAA guidelines. As mentioned earlier, per the HIPAA act, the covered entities must supervise physical, technical, and administrative safeguards for PHI, ensuring privacy, integrity, confidentiality, and security of healthcare data.
It’s crystal clear now why HIPAA compliance in healthcare app development is an absolute necessity. So if you are a healthcare provider looking to develop a mobile healthcare app that contains PHI, you must follow HIPAA guidelines without any second thought.
The HIPAA-Compliant Healthcare Rules You Must Know Before Developing a Mobile App
HIPAA Privacy Rule aims to protect individuals’ medical records and other personal health information held by covered entities, defined as health care clearinghouses, employer-sponsored health plans, health insurers, and medical service providers.
This rule enforces limitations on the various uses and disclosures that can and cannot be made without patient authorization. Under this rule, patients can examine and receive copies of their health records and request corrections to their files.
As a subset of the Privacy Rule, HIPAA’s Security Rule applies (specifically) to electronic personal health information (aka ePHI). This rule aims to protect individuals’ electronic personal health information that is created, received, used, and/or maintained by covered entities.
Broadly speaking, the HIPAA Security Rule requires implementing three types of safeguards — administrative, physical, and technical to ensure the confidentiality, integrity, and security of one’s health information.
HIPAA Enforcement Rule falls under the US Department of Health and Human Services (HHS) jurisdiction and other governmental agencies. It involves strict monitoring for enforcement of the Privacy Rule (since 2003) and the Security and Breach Notification Rules (since 2009), containing rules on compliance, investigations, hearings, and penalties for violations.
Under this rule, the HHS reserves all the rights to hold businesses accountable with fines and other penalties for noncompliance. Depending on the breaches and violations, it can cost businesses from $100 to $1.5 million or sometimes $250,000 along with up to ten years imprisonment.
The Breach Notification Rule
Any impermissible use or disclosure of PHI by anyone other than covered entities is considered a breach. HIPAA’s Breach Notification Rule intends to notify patients when someone impermissibly uses or discloses their protected health information (PHI), compromising the privacy and security of the health information.
Under this rule, if the breach involves more than 500 individuals, a covered entity must notify media outlets serving the state where the violation happened, along with informing HHS without unreasonable delay or up to 60 calendar days following the date of discovery. However, if the breach affects less than 500 individuals, covered entities can maintain a log of the relevant information and notify HHS within 60 days.
The Omnibus Rule
HIPAA Omnibus Rule mainly requires healthcare providers to update their Business Associate Agreements (BAA), ensuring that they comply with the HIPAA rules. In 2013, the US Department of Health and Human Services (HHS) released its final Omnibus Rule to increase HIPAA privacy and security protections.
The Omnibus Final Rule (the most recent addition to HIPAA) is the modifications to the Security, Privacy, Breach Notification, and Enforcement Rules, intended to enhance confidentiality and security in data sharing. This rule was passed to strengthen patients’ privacy and protect health information in an increasingly digital world.
How to Develop HIPAA Compliant Healthcare Mobile Apps? 5 Essential Steps Required
Developing a HIPAA-compliant mobile app is not like your everyday app development. You need to keep precision in mind and follow the HIPAA rules and guidelines diligently. Here are some crucial steps to build a HIPAA-compliant healthcare mobile app.
Step 1: Get the Help of Experts
HIPAA’s rules and guidelines are vast and complex. And if you will try to meet the requirements without proper knowledge and guidance, your healthcare app will fall flat. Hence, it’s better to consult an expert healthcare app development company that is well-versed with the HIPAA act. Getting expert advice can help you with essential consultation, audit your system, and make the entire process seamless.
Step 2: Evaluate Patient Data & Distinguish PHI from Other App Data
Healthcare institutions usually have access to confidential patient data. This data can easily be stored, shared, and maintained via a mobile app. You need to check the information you collect from patients and separate the PHI data. After that, check what PHI data you can’t store or transfer through your mobile app. It’s a crucial step in healthcare app development to design the database accurately.
Step 3: Find Third-Party Solutions That Are Already HIPAA Compliant
HIPAA compliant app development can be expensive. And that’s why experts generally advise using HIPAA compliant infrastructure and solutions (third-party solutions that are already HIPAA compliant) rather than developing HIPAA compliant mobile apps from scratch. Amazon Web Services (AWS) and TrueVault are great examples of the same.
Note: You need to sign a business associate agreement (BAA) if you choose to use a third-party solution for storing and managing PHI data.
Step 4: Encrypt All Transferred and Stored Data
You must use security practices to encrypt the sensitive information of patients. Before that, you need to ensure that there are no security breaches. By using various levels of encryption to secure the stored data from getting stolen from a device. You can always use the App Transport Security (ATS) measure For HIPAA-compliant healthcare app development for better encryption.
Step 5: Test and Maintain the App for Security
Testing is one of the most crucial steps for making every app successful; however, it’s often overlooked by many. To keep your healthcare app up and running flawlessly, you can take our expert app testing services that ensure meticulous testing and test your application both dynamically and statistically. Ensure testing the app after every update. And, if any issue is identified, it should be fixed ASAP without any delay.
How to Apply HIPAA to Your Healthcare Mobile Application? 9 Steps to Achieve HIPAA Compliance
Get Access Control
A HIPAA compliant mobile app that stores PHI must enforce limitations on seeing or modifying confidential health-related information. Why? Because the HIPAA Privacy Rule clearly states that access of patient information should be based on clearance level and requirement. To get control access, assign a unique ID to each user, create a list of privileges, assign these privileges to different groups, and more.
Identification Proof for Authenticity
Once the unique ID is assigned, and role-based accesses have been given, next comes the user identification. In this step, you must verify precisely who is accessing PHI. Biometric data, passwords, physical methods (for distinguishing proof), OTP, smart token, 2FA/MFA, and PIN are some authentication methods you can use to add extra security for HIPAA-compliant healthcare mobile apps. Ensure the safest way to log in.
Ensure Transmission Security
Transmission security ensures that PHI being transmitted over the app network is fully encrypted during transmission. For instance, the HTTPS protocol encrypts information with SSL/TLS. With the help of a unique algorithm, it seamlessly transforms PHI into a series of characters. Also, you can use AWS, Firebase, Google Cloud, or any other prominent services that run Transport Layer Security to encrypt data during transmission.
Use Proper PHI Disposal
PHI disposal is another crucial HIPAA requirement that you need to fulfill. To protect patient privacy, archived and backup data that have expired should be disposed of permanently as per the US Department of Health & Human Services (HHS). Moreover, HIPAA does mandate that unused media containing PHI should be adequately destroyed and not simply left behind or disposed of in a public receptacle.
Under the HIPAA Security Rule, covered entities and business associates must implement automatic logoff procedures for HIPAA-compliant apps to keep the security intact. Often, users forget to log out of an app that results in data loss or theft. Auto logoff ensures that the app is pre-programmed to close a session after a set of inactivity automatically. This will help PHI from being mishandled; thus, significantly improving security.
Evaluate Audit Controls
The audit is an essential step during HIPAA-compliant healthcare app development that shouldn’t be neglected. Why? Because the negligence of audit controls can prompt higher fines. So it’s best if you can monitor what is being done to the PHI stored in the app. Record each time the users sign all through your framework. This way, you will be aware of all the operations performed within the HIPAA mobile app.
Encryption is the best way to protect the data from intruders and keep it safe. It enables data transfer over a network without risks, ensuring data integrity. You can achieve it by creating codes that need a decryption key to convert the data in a human-readable format. With that being said, you can use RSA and AES algorithms with vital keys or encrypted databases like SQLCipher for (securely) storing the data in the backend.
Ensure Data Backup and Storage
A timely backup can help avoid most problems associated with data loss. To establish data integrity, it is imperative to have a retrievable backup. Ideally, the backup should be located on a server, which is located in another data center. Multiple backups stored in encrypted hardware or secured data cloud helps in sensitive data protection. This way, you can guarantee maximum data security on a HIPAA-compliant mobile app.
Maintenance is a vital step, ensuring your healthcare app’s stability and efficiency. You must employ regular maintenance to ensure that your app is safe, stable, and free from all types of bugs, breaches, glitches, and crashes. Besides, to maintain the app’s integrity, you must always test the application dynamically and statistically, especially after every upgrade, to ensure the app is working smoothly on all the targeted platforms.
What Are the Penalties for HIPAA Violations?
HIPAA violations are severe and can affect your business in multiple ways. Besides, it (in turn) can attract heavy penalties and fines. The US Dept. of Health and Human Services imposes stringent civil and criminal penalties as mandated by Congress.
That’s the reason; if you’re developing a HIPAA-compliant app, you need to know the penalties for HIPAA violations so that you can be prepared and avoid future issues.
As discussed earlier in this guide, HIPAA has strict rules and regulations covering privacy and security. The restrictions apply to covered entities. If they fail to comply with HIPAA rules, they will have to face harsh penalties. Having said that, since 2019, the fine for a violation has been adjusted per tier.
There are a total of four tiers used for the penalty structure, with the maximum fine at Tier 4 (the most severe violation) remaining at $15,00,000.
Fines for dissent depend on the severity of negligence and can range anywhere from $100 to $50,000 per violation up to a maximum fine of $1.5 million. Some violations also take criminal charges that can result in possible jail time and extra penalties. Moreover, the most severe offenses can result in a 10-year jail sentence with a $250,000 fine per violation.
By now, you must have realized how serious and crucial it is to protect health information.
Consequently, you shouldn’t take these penalties lightly when you’re developing a HIPAA-compliant app and focus more on preventing them. Here’s how!
How to Prevent Potential HIPAA Violations
If you think you’re safe from preventing HIPAA violations just because you have a firewall network or encrypted email, you need to think again.
Humans are prone to making mistakes. In fact, data reveals that more than half of all HIPAA data breaches are caused by human error. As you know that HIPAA violations can cost you both — your reputation and money. As mentioned earlier, those affected by a HIPAA violation can result in substantial fines to a practice ranging from $50 to $1.5 million or even more.
So if you own a healthcare mobile app that is HIPAA compliant or thinking of developing one, it becomes imperative for you to know how to prevent HIPAA violations in easy and quick steps. Here’s how you can prevent yourself from HIPAA violations.
Have a look:
- Stay Updated with HIPAA Latest Guidelines
- Enable Encryptions and Firewalls
- Keep Mobile Devices Secure
- Don’t Share Login Credentials
- Don’t Disclose Patient Information
- Dispose of Expired PHI Documents Carefully
- Do Not Share ePHI on Social Media
- Regularly Review and Improve Security Procedures
- Report as Soon as You Encounter HIPAA Violation
To conclude, we would say that developing a HIPAA-compliant healthcare mobile app is not a piece of cake; a lot goes into it. The penalties for bypassing the HIPAA compliance rules and regulations are massive.
However, we believe that building a HIPAA-compliant app doesn’t have to be an intimidating experience. That said, if you keep all the learnings (from this guide) in mind, you can indeed create a successful healthcare mobile app backed with HIPAA compliance.
With some strategic planning, you need to put all the shared learnings into action and build a well-secure healthcare app that can be a huge success. Good luck!