The Health Insurance Portability and Accountability Act (HIPAA) is the most significant piece of legislation for anyone who wants to develop healthcare-related software for the US market. It was enacted in 1996 to govern the privacy of patient data, minimize the cost of healthcare, and guarantee continuous health insurance coverage for those who leave or change jobs.
During the healthcare app development, it is difficult complying with HIPAA, and simply knowing all of its criteria is far more complicated. Smartphones and wearables have become widely utilized in hospitals and insurance companies in recent years to connect doctors to patients and track their health. Smartphone apps that process, receive or transmit sensitive data in any way must be HIPAA-compliant.
During the app development for healthcare in the US market, you must determine what information you will keep and transfer through your application. There are two kinds of information:
- PHI (protected health information) – includes doctor bills, emails, MRI scans, blood test results, and any other medical information (notice that geolocation information that locates a person within a territory smaller than a state is under PHI);
- CHI (consumer health information) – contains data from fitness trackers, such as the number of calories burnt, heart rate measurements, and steps walked.
The guideline is simple: if your application processes, stores or transfers PHI data, it must be HIPAA-compliant. Let’s first understand why healthcare mobile app development must be under HIPAA.
The Importance of HIPAA Compliance
1. For Patients:
According to HIPAA regulations, no entity may forward any patient’s information. Instead, only healthcare professionals are allowed to disclose patient information with stakeholders. Furthermore, safeguarding stakeholders involved in healthcare operations under the PHI (protected health information) is necessary. In exchange, it ensures privacy and confidentiality. Prescription vendors and billing professionals cannot submit patient information ahead of time. Since patients have extensive rights to their medical information, entities must notify them about a breach. Furthermore, it enables easy data exchange flow among multiple healthcare organizations.
2. For Hospitals:
Hospitals that do not comply with HIPAA are likely to face hefty fines. Individual data breaches are punishable by fines ranging from $100 to $50,000. However, the penalty for one entity does not exceed $1500,000 per year for one category. After being unable to encrypt complete data on portable devices, the Medical Center for Children in Dallas paid $3.2 million as punishment.The question then becomes, how can we avoid such hefty fines while keeping our patients’ data safe and secure? You must follow a set of regulations to do so. In the following section, we will go through those guidelines in further detail.
HIPAA-Compliant Healthcare Regulations
A HIPAA-compliant healthcare system requires stakeholders and entities to help patients with treatment. To roll out their products while dealing with sensitive clinical data, startups or SaaS development organizations must adhere to such standards. In general, HIPAA focuses on four principal regulations to secure patients’ data: Privacy Rule, Security Rule, Breach Notification Rule, and Enforcing Rule.
The Security Rule is critical from the standpoint of an App Developer or a Company since it targets numerous physical and technical safeguards required in satisfying HIPAA compliance.
1. Physical Security for a HIPAA-Compliant Healthcare App:
The Physical Safeguards parameter improves the security of the backend network, data networks, and associated devices that can be physically compromised. Furthermore, this parameter focuses on users who can directly access PHI data and manage access. It typically addresses the following issues:
a. Device Controls
Steps used to handle device controls:
- Policy formulation and execution at the media or hardware disposal that stores information
- Controlling the movement of hardware and electronic media
- Making a copy of PHI before moving the equipment, design or backup
b. Controlling Facility Access
Control in healthcare IT systems comprises developing plans to deal with network outages, access control processes, security challenges, and maintenance restrictions. To manage access control, you can go through the following stages:
- The protocol setting facilitates access control when emergency assistance is necessary under emergency operation protocol or disaster recovery protocol.
- You must protect the equipment and facility access from data theft and illegal access during policy execution.
- Policy implementation to validate stakeholders’ requests for facility access control based on their roles.
- You should create policies to modify physical premises and boost security.
c. Workstation Security
Steps used to handle device controls:
- You must establish the rules for carrying out suitable functions and dealing with PHI.
- The physical standards’ implementation for workstations while preventing or accessing unlawful data access
2. Technical Security Measures for HIPAA-Compliant Healthcare App Development:
Technical Safeguards parameters redefine the actual procedure required by HIPAA-compliant mobile apps. Its components that are beneficial for implementation during the mobile app development are as follows:
a. Access Control Requirements
It refers to the following practices:
- To develop healthcare policies that will allow access in an emergency
- Automatic/immediate log-off process that occurs quickly after the system has been dormant for a certain period
- User authentication to validate their identity
- Personal data encryption and decryption are carried out
Such apps ensure that all entities covered use the same nationally recognized identities and code sets.
b. Integrity and Auditing
- Hardware and software implementation are carried out for a workflow mechanism that analyzes the activities that aid in the storage of patient information.
- It ensures that data is modified only after user authorization.
c. Transmission Security
- Data encryption is performed when required during transmission.
- Security measures are implemented to reduce the possibility of illegal modification or access without user detection.
Developing a HIPAA-compliant Medical App
Step 1: Locate a professional.
If you lack experience, don’t try to meet all HIPAA regulations on your own. It is usually preferable to opt for healthcare mobile app development services to evaluate and audit your system. You may also outsource the entire HIPAA-compliant app development process to an app development company. Finding an expert is beneficial for both startups and large healthcare organizations.
Step 2: Analyze patient data.
Check if you need all the data you acquire from patients, and determine what data can be classified as PHI. After that, consider what PHI data you can avoid storing or uploading via your mobile app.
Step 3: Look for third-party solutions that are already HIPAA-compliant.
Providing HIPAA compliance for an application is quite expensive. Initiating app development for healthcare from scratch is a costly affair. It’ll involve developing a whole system that meets physical and technical security requirements. You’ll also need to invest money auditing this system and obtaining the essential certifications.
Instead of designing HIPAA-compliant mobile apps from scratch, the easiest way to save time, money, and effort is to employ a ready infrastructure and already HIPAA-compliant solutions with the assistance of a healthcare app development company. It’s referred to as IaaS or infrastructure as a service. For example, Amazon Web Services and TrueVault are HIPAA-compliant and accountable for data protection.
To use healthcare mobile app development services for storing or managing PHI data, you must execute a business associate agreement with the app development company.
Step 4: Data Encryption
Encrypt your patients’ sensitive data using security best practices. Use multiple levels of encryption and obfuscation to ensure that there are no security vulnerabilities. Take care to encrypt saved data to prevent it from being taken from a device.
Step 5: Maintain and test your app’s security
Testing is critical, and it should be performed after each upgrade. Test your application statically and dynamically, and speak to an expert to update the documentation.
Maintenance is a continuous procedure that must be carried out to preserve your application security. Libraries, tools, and frameworks for developing apps and assuring their security are continually upgraded. After creating a HIPAA-compliant mHealth app, you must ensure that it is constantly updated; otherwise, a security breach may occur.
Benefits of a HIPAA-Complaint App
This app should include specific elements that ensure the security of a patient’s information.
1. Chat and Messaging
Patients may have an immediate question or require assistance or a suggestion on something. In such instances, this tool comes in handy. The HIPAA-compliant messaging app serves as the foundation for a smooth dialogue between the doctor/nurse/healthcare professional and the patient.
2. Reminder Update
The built-in reminder feature will ensure that every patient receives a timely reminder for their forthcoming doctor’s appointment. When doctors and nurses are not available, patients will be well-informed.
3. Schedule Appointments
It was simple to schedule visits and follow up with doctors. Patients should be able to arrange appointments with simplicity, right? That is what a HIPAA-compliant app accomplishes for patients. It enables users to reserve a period that suits their needs. The app provides a doctor’s calendar with available time slots.
For Doctors/Healthcare Institutions:
This app should include capabilities that provide the doctors with a streamlined service management system.
1. Safe Data Sharing
HIPAA-compliant apps provide a secure messaging platform. You can manage appointments easily and ensure that confidentiality is maintained.
2. Save Patient Data
Doctors require more time to treat patients and less time to seek patient files. Any healthcare app should include simple messaging options and efficient data transfer. The program must support good graphics, charts, PDF files, reports, photos, and videos on a single screen.
3. Send and Receive Notifications
The app must offer timely notification on all devices. Simple reminders for upcoming visits would save doctors time and treat more patients.
1. Development Cost of HIPAA-complaint App:
It isn’t easy to place a price tag on app development costs, especially when designing a HIPAA-compliant app. All mHealth apps have distinct scopes, and hence, HIPAA healthcare mobile app development expenditures can vary from $19,000 to $190,000. The cost of HIPAA compliance in the healthcare business is close to $8.3 billion per year, with each doctor spending roughly $35,000 per year to keep the health information technology secure. We’ve realized that it’s better to err on the side of caution and integrate HIPAA-related technology even when developing an MVP that doesn’t use PHI. HIPAA will eventually become a requirement. Thus, it’s best to include the app’s architecture from the beginning. If you choose an out-of-the-box HIPAA-as-a-Service solution, the magic number will be roughly $2,000 per month.
2. Ignorance Cost of HIPAA:
Suppose you decide to design HIPAA-compliant software while ignoring any legal standards. In that case, it could be a costly mistake. Let’s look at a few scenarios that show the expected costs if you decide it’s not worth developing a HIPAA-compliant mobile app.
Aetna Life Insurance Company:
Involved in three data breaches, one of which included digital malpractice, allowing Google and other search engines to index health plan-related documents. ALCI had to settle for a $1,000,000 fine with the Office for Civil Rights (OCR).
Metropolitan Community Health Services:
The nonprofit health facility serves around 3000 patients each year and has agreed to pay a $20,000 fine for failing to comply with the HIPAA Security Rule. OCR considered MCHS’s focus on the underserved community in rural North Carolina. As a result, the penalty is bearable (but still unpleasant).
Lastly, the average fine for violating HIPAA compliance rules and regulations for mobile app development in 2022 is roughly $940,000.
Collaborate with a healthcare mobile app development partner to create HIPAA-compliant apps. As you make a HIPAA-compliant application that satisfies these high criteria, consider the fact that the faster the app can be downloaded and used, the better it is.
Obtaining and preserving information are critical for HIPAA compliance for mobile apps. Consider the following areas when building a HIPAA-compliant program:
- Data security and backup procedures
- Credential management and security concerning sensitive data
- Assessing the viability of a potential program
- Setting risk reduction as a top priority
At RV Technologies, a healthcare app development company, we recognize that risk reduction includes a structured validation procedure. We have the capability of identifying, evaluating and removing any knowledge of known or unknown vulnerabilities to the platform before its deployment online. We perform a security scan to assess their platform and ensure that no known security vulnerabilities exist. The next stage is to evaluate physical and digital assets visually. And later, test them for known and unknown data security vulnerabilities.