Last Updated on January 21, 2022
The healthcare industry has been one of the top sectors and is accepted today during the COVID-19 crisis. Resultantly, the enhancement of healthcare mobile app development is catching up at a faster pace. That’s why almost every healthcare IT solution provider is also giving importance to such a scope.
In this world of digitization, healthcare service providers and their associates invest in modern and advanced solutions to stay ahead of their competitors. In addition, the increasing use of internet solutions has provided a pathway to various threats that were even unheard of earlier. For example, most mobile apps demand users’ information to start running.
Besides, various healthcare service providers are matching up with the HIPAA-compliant healthcare app standards for their solutions.
Today, in this post, we will learn everything relevant to HIPAA-compliant healthcare apps, how to develop them, the budget you need, and a lot more. So, keep reading.
What Is HIPAA?
HIPAA, the Health Insurance Portability and Accountability Act, was developed in 1996 to control the safety of patient data, cut down the healthcare cost, and offer constant healthcare insurance coverage for those who change or lose their jobs.
Smartphone applications should process, retrieve, or send private data as per HIPAA compliance.
Wearables and smartphones are much in use in recent years in the hospitals and by the insurance companies that help connect the doctors with patients and track their health. It’s essential that smartphones that receive, process, or send private data need to be HIPAA compliant. That’s why today, mHealth App Development with HIPAA requirements is a must-have for some mHealth apps.
Why Is HIPAA Compliance Important?
HIPAA is a complete act that is known for assisting patients and healthcare institutions. That’s why it’s crucial to understand for both the stakeholders while developing HIPAA-compliant software.
For The Patients
Under the HIPAA compliances, no entity may forward information of any patient. Instead, just the healthcare professionals are allowed to share the patients’ details with stakeholders. Moreover, those stakeholders who are part of healthcare operations should be protected under the PHI (Protected Health Information). It, in exchange, makes sure about the privacy and confidentiality levels.
The prescription vendors and billing professionals can’t send patients’ information ahead.
Entities should make the patients know about a breach as they hold comprehensive rights to their medical information. Moreover, it permits seamless data sharing flow among various healthcare institutions.
If hospitals don’t follow HIPAA compliance, they are likely to pay huge fines. A fine of $100 to $50,000 is applicable in case of an individual data breach. However, the penalty for one entity doesn’t exceed $1,500,000 per year for one category.
Medical Center for Children’s at Dallas paid $3.2 million fine after becoming unable to encrypt entire data on portable devices.
Next, a question arises, how can we prevent such heavy fines and keep our patients’ data safe and secure. Well, for that, you should follow a set of rules. In the next part, we will discuss those rules in detail.
What Are HIPAA-Compliant Healthcare Rules For Developing A Mobile Application?
A HIPAA-compliant healthcare solution needs the stakeholders and entities to ease patients with treatment. The startups or SaaS development companies need to stay compliant with such norms to roll out their solutions while dealing with delicate clinical information. In general, HIPAA focuses on four chief regulations to secure patients’ data, they are:
- Privacy Rule
- Security Rule
- Breach Notification Rule
- Enforcement Rule
From the point of view of an App Developer or Company, the security rule holds much importance as it targets various physical and technical measures needed to meet HIPAA compliance.
Physical Safeguards For A HIPAA-Compliant Healthcare App
The parameters of Physical Safeguards facilitate the security of the backend network, data networks, and interconnected devices that can be physically compromised. In addition, this parameter also targets the users who can access the Protected Health Information (PHI) data directly and conduct access management. Usually, it deals with the below aspects:
The steps that manage device controls are:
- The policy development and implementation at the media or hardware disposal that stores information.
- Executing the policies for deleting data before using the device from media storage systems.
- Holding the movement of hardware and electronic media.
- Creating a replica of PHI before moving the equipment or design or backup.
HIPAA-Compliant apps help in increasing personal privacy and secure the confidential health information sharing process.
Facility Access Control
Such control in healthcare IT solutions includes setting up the plans to handle network contingencies, access control processes, security issues, and maintenance regulations. You can go through such primary stages to manage access control:
- The protocol setting eases access control when emergency help is required under any emergency operation protocol or disaster recovery protocols.
- You need to secure the equipment and facility access from any data theft and unauthorized access in the policy execution.
- The policy implementation to validate the stakeholders’ request to the facility access control depending on their role.
- You should develop policies to change physical premises and improve security.
It includes the below steps:
- You should define the regulations to conduct proper functions and deal with PHI.
- The physical standards implementation for workstations while restricting or accessing unauthorized access of data.
Technical Safeguards For HIPAA-Compliant Healthcare App Development
Technical Safeguards parameters redefine the actual workflow that HIPAA-compliant mobile apps need. Its aspects that are beneficial to implement in the app to attain the technical measures are:
Access Control Requirements
It points to the practice of the following:
- The allocation of unique user identification code names and numbers is done to track user identity.
- To create healthcare policies for allowing access when there is an emergency case.
- Automatic/instant log-off process immediately after the system becomes inactive for a specific time.
- Use authentication for confirming their identity.
- Encryption and decryption of personal data are also performed.
Such apps make sure that all the covered entities use the nationally recognized identifiers and the same code sets.
Audit & Integrity
It includes the specifications like:
- Hardware and software implementation is performed for a workflow mechanism that examines the activities that help store patient information.
- It ensures that data is changed or erased post user authorization only.
A healthcare mobile application development company implement many transmission security measures and above that are beneficial to consider in your HIPAA-compliant app solution:
- Data encryption is done when we need it during the transmission.
- The security measures implementation is done to diminish the chances of any unauthorized modification or access with no user detection.
How To Know If Your App Needs To Be HIPAA Compliant?
Various entities look for HIPAA Compliant mobile app development services to know whether their app needs to be HIPAA-compliant or not.
We are here to help you with this.
Suppose the mobile app you are building shares the personal health-related information of the patients with doctors or any stakeholders. In that case, it comes under PHI, and your mobile app should be HIPAA compliant.
On the contrary, if information stays within the app, it doesn’t need to be HIPAA compliant.
To be PHI, this information must also be used or transmitted by a “covered entity” or “business associate.”
A covered entity can be either
- a healthcare provider
- a health plan
- a healthcare clearinghouse that handles PHI.
Business associates can include
- IT professionals
- Billing providers
- Email encryption services
- Anyone who works on behalf of a CE (HIPAA Covered Entities) and therefore also handles PHI.
Handling the private and personal medical information of app users securely can be a complicated task for mobile developers inexperienced with HIPAA. So, if you are planning to develop an app in this niche then hire an app development company that is experienced with developing a telemedicine app or healthcare mobile app.
An App Doesn’t Need To Be HIPAA Compliant Vs. An App Should Be HIPAA-Compliant
|HIPAA-Compliant App||Not a HIPAA-Compliant App|
|Type of Data||Contains PHI||Collects data|
|Type of Data||Data is related to the physical and mental health of patients.||For personal use|
|App Usage||Provided by health plans and used to conduct transactions.||Patients use the app to monitor their health and share data with providers.|
|Data Usage||The app vendor receives payment from a covered entity and builds, receives, discloses, and maintains PHI.|
|Example||An insurance providing app||A fitness tracking app|
How To Develop A HIPAA Compliant Mobile App
While building a medical app for the market, you need to find what type of information you will store and transfer it through your app. There are two sorts of information:
PHI (Protected Health Information)
It includes emails, bills from doctors, blood test results, MRI scans, and other types of medical information.
HIPAA apps necessitate the usage of strong passwords and make sure that providers should hold data backup plans.
PHI Personal Identifiers
These are 18 personal identifiers those when included with a patient’s health information, make the information “protected“.
|Names||Geographical identifiers||Dates directly related to an individual|
|Phone numbers||Fax Numbers||Email addresses|
|Social Security numbers||Medical record numbers||Health insurance beneficiary numbers|
|Account numbers||Vehicle license plate numbers||Certificate or license numbers|
|Device identifiers and serial numbers||Web URLs||IP addresses|
|Fingerprints, retinal, and voiceprints||Full face or any comparable photographic images||Any other unique identifying characteristic|
CHI (Consumer Health Information)
It includes data you get from a fitness tracker, such as the heart rate, the number of burnt calories, and the number of steps covered walking.
Here, the rule is simple: if your application stores, processes, and shares any PHI data, it needs to be HIPAA compliant.
Most common types of healthcare apps that need to be HIPPA compliant
- Telemedicine (doctor on-demand & e-Prescription) apps
- Condition-based healthcare apps
- EHR (Electronic health records) apps
A few mHealth apps that do are not subjected to HIPAA
- Workout programs apps
- Diet apps
- IoT Fitness apps
Steps To Develop A HIPAA Compliant Mobile App
Step 1: Hire A HIPAA Compliant Mobile App Development Expert
If you don’t have the necessary experience, you can’t fulfill all HIPAA requirements without proper guidance. Therefore, it’s better to find a 3rd-party expert who can help you with essential consultation and audit your system. Moreover, you can outsource the complete HIPAA-compliant app development process from a skilled and experienced team. Be you are a startup or a leading healthcare brand, you should find an expert; it would be helpful. Well, there are many choices available in the market.
Step 2: Evaluate The Data & Distinguish PHI From Other App Data
Check the data you collect from your patients and separate the PHI data. After that, check what PHI data you can’t store or transfer through your mobile app.
Step 3: Emerge With 3rd-Party Solutions That Are HIPAA Compliant
It’s costly to make a HIPAA-compliant mobile app. To start developing your custom HIPAA app, you need to have a budget of at least $50,000. This cost will include the development of the entire system that should meet physical and technical security needs. Besides, you will need to spend some time auditing the system, getting all the essential certifications, and more.
Such apps diminish medical errors and lead ahead to control auditing of the system.
You may use HIPAA compliant infrastructure and solutions rather than developing HIPAA compliant mobile apps from scratch. For example, AWA and TrueVault.
You should sign a business associate agreement with 3rd-party brands and ensure their reliability to use 3rd-party service for storing and handling PHI data.
Step 4: Encrypt All Transferred & Stored Data
You need to use security practices to encrypt the sensitive information of your patients. First, be sure that there are no security breaches. Also, use various levels of encryption and obfuscation. Also, remember to encrypt your stored data to secure it from getting stolen from a device.
Step 5: Test and Maintain Your App for Security
It’s always important to test your mobile app, especially after every update. You should test your mobile app both dynamically and statistically. Moreover, you should take your expert consultation to check whether your documentation is up to date.
A constant process of maintenance is essential to perform to keep your app safe. Tools, libraries, and frameworks help in building an application and ensure its security is updated constantly. For example, after you develop a HIPAA-compliant mHealth app, you should ensure you update them regularly, or else a security breach may emerge.
Things To Consider While Hiring Mobile App Developers For Developing HIPAA Compliant Apps
While developing a HIPAA-compliant mobile app, the app developers should know the HIPAA guidelines. In addition, they should consider the following needs:
Developing a HIPAA-compliant app is a complicated process. First of all, the app developer who is building your mobile app should have complete knowledge about many aspects of HIPAA and the process of mobile app development. In addition, he should know everything related to PHI. As per the US Department of Health and Human Services, there are 18 types of information under the PHI which we have outlined in a table above. Therefore, if the app performs with any kind of information among these 18 types, the developer may move ahead to offer HIPAA-compliant app development services.
This includes the creation of unique user identification. You should consider it as it assists in emergency app access processes and log-out sequences. Furthermore, use the services like Google Cloud or AWS that implement Transport Layer Security. It helps ensure that the data is encrypted; that’s why it is safe during transmission.
Besides, the mobile app developer developing a HIPAA compliant mobile app should ensure that the app installation’s devices should not receive any PHI data notifications. It is very crucial for securing patient health information.
The mobile app developer should ensure that the data is transmitted securely with no possibility of data leakage later. Moreover, he needs to ensure the security of backend support systems and data transfer networks. Also, he should check device interactions. Besides, your developer should conduct all the essential steps while developing a HIPAA-compliant app to protect ePHI. Apart from that, the app should share the necessary information only across all the distinct platforms. It should also limit sharing and usage of PHI to the primary level.
If you want to ensure that only the concerned person accesses the data, Information Access Management is essential. It’s not safe to permit users to log in using email. You need to use very secure ways, like Biometric Identification or Card, or Smart Key for safe login. Besides, you can also apply the features, such as face scanning or fingerprint authentication. At the same time, you should ensure that the app is user-friendly.
You should clean data frequently at any stage and shouldn’t allow the accumulation of too much data. The mobile app developer who offers HIPAA-compliant mobile app development services should conduct backup and archive data that has expired. In addition, you should try ways to dispose of unused data securely.
It is easier said than to develop a HIPAA-compliant app. It holds various aspects that are necessary to follow. However, you can move ahead and hire an experienced HIPAA mobile app developer who knows HIPAA rules and regulations and can create an app as per your business needs.
HIPAA-Compliant apps need the covered entities to implement various defenses to safeguard sensitive health and personal information.
How Much Does It Cost To Build A HIPAA-Compliant App?
Well, it’s not easy to settle at an estimated figure of app development cost, especially when it comes to developing a HIPAA-compliant mobile app with distinct scopes. That’s why the budget of HIPAA app development varies.
According to most of the companies, it ranges from $19,000 to $190,000.
All over the industries, the cost of a HIPAA-compliance is approximately $8.3 billion a year, taking along $35,000 a year, which’s the charge for protecting health information technology.
As the health sector is affected by the COVID-19 crisis, that time is not far when digital healthcare transformation will rule this industry. So, soon the apps will start shifting to compliance.
So, the digital healthcare owners who will take no time to understand the importance of the compliances today and implement them in their medical or healthcare app or software will likely witness success tomorrow.
Emizentech has an experienced app development team that can help you develop a HIPPA compliant healthcare app. If you have a project in mind please let us know.