How to Make Your Mobile App HIPAA Compliant

As a result of a need for HIPAA-compliant software, mHealth (mobile Health) applications are one of the most complicated to develop. Yet, there arises the highest obligation to protect sensitive patient information. All types of healthcare software must adhere to the 1996 Health Insurance Portability and Accountability Act (HIPAA).

This comprehensive guide explores the core requirements for achieving HIPAA compliance for healthcare apps. We’ll go over HIPAA compliance requirements for mobile health applications.

Disclaimer

The details in this article are intended to be general only. Laws differ greatly depending on the facts. Because rules, norms, and restrictions change, this post may contain errors. OS-System and its team do not provide legal counsel. This article can not be used or interpreted as an alternative to legal advice.

What is HIPAA Compliance?

HIPAA, also known as Public Law 104-191, is a 168-page book entirely engrossing for interpreting. The U.S. Department of Health and Human Services (H.H.S.) governs HIPAA. If you want to create a medical app, you should look into the requirements of the United States Food and Drug Administration, as well as the FTC.

HIPAA compliance for healthcare applications means implementing full-fledged protective measures safeguarding the patient information from collection and storage through transmission, and disposal. HIPAA compliance consists of four major regulations:

• Privacy Rule. Applies to protected health data.
• Security Rule. Consists of administrative, tangible, and technological safeguards.
• Breach Notification Rule. Procedures to follow in the event of a security incident.
• Enforcement Rule. Civil law penalties are imposed if the rule is not followed.

Violation of shielded healthcare information can endanger lives. That, by itself, is the leading cause enough to adhere to HIPAA. Overall, lawsuits are not being brought forward for HIPAA violations, but this is not sacrosanct according to Connecticut verdicts. In any case, civil suits can be filed for infractions of state and federal statutes. HIPAA-compliant medical software decreases the risk of civil claims for healthcare providers by assisting in preventing threats to guarded healthcare data in the first place.

For medical app developers, awareness and adherence to HIPAA compliance in medical app development are crucial. This is the only way to develop applications that can be securely integrated into healthcare processes without compromising the highest level of data protection standards.

The Primary Purpose of HIPAA

So, let’s start with 4 primary purposes of HIPAA compliance for medical apps.

Protecting Patient Privacy and Confidentiality

The basis for HIPAA law is the protection of patient privacy through the imposition of rigorous controls on access, use, and disclosure of Protected Health Information. For mobile app HIPAA compliance, developers will be required to incorporate privacy-by-design methods, so patient data is protected from the moment it is received, right through all stages of processing and storage.

Developing Security Standards for Health Information

HIPAA sets far-reaching security standards that protect electronic Protected Health Information from cyber attacks, data breaches, and misuse. In defining HIPAA compliance for healthcare uses, organizations must adopt robust security models, including:

• Encryption;
• Access controls;
• Audit logs;
• Incident response protocols.

HIPAA standards require covered entities and their business associates to implement administrative, physical, and technical safeguards.

Maintaining Administrative Simplification

For developers creating medical apps with HIPAA compatibility as a priority, this means making the apps able to integrate easily with existing healthcare infrastructure. All security and privacy measures must be in place.

Providing Insurance Portability

The initial aim of HIPAA was to ensure that individuals could maintain health coverage when changing jobs or plans. Although this is the section that may appear less relevant in app development, it’s all about continuity of access to health information across platforms and providers.

This need affects the overall approach of mobile health apps towards data portability and patients’ access rights. Patients must access their health data irrespective of whether they change healthcare providers or insurance status.

Core HIPAA Requirements for Medical Applications

Next, let’s discuss the requirements of HIPAA compliance for medical apps. This will help you develop a robust healthcare app even when you chase top healthcare trends and innovations.

Privacy Rule Implementation

Under HIPAA’s Privacy Act, Protected Health Information (PHI) shields all previous, present, and prospective “personal health information kept or transferred by a public body or its former business partner, in any shape or form, whether digital, journal, or verbal.”

ePHI is another term for Digital Protected Health Information. Primarily, any of the data formed, saved, transferred, or received electronically, via any electronic gadget or storage medium, falls under this category.

In achieving HIPAA compliance for healthcare systems, developers must implement strict control on access to PHI for only those authorized to view, modify, or transmit the patient data. This entails:

• Implementation of role-based access controls;
• Maintaining scrum-purposed access logs;
• Establishing strict policies governing PHI usage and disclosure.

There are no exemptions without going all sci-fi with telekinesis, just because of a bit of fun. However, even this can be asserted to necessitate the use of electronic devices. What is considered sci-fi may not be considered sci-fi later today.

Security Rule Technical Safeguards

According to HIPAA’s Security Rule, government agencies and their contractors must carry out a risk assessment of healthcare organizations. The purpose of this analysis is to assist your company in remaining compliant with HIPAA’s institutional, physical, and technological safeguards. These are likely to be relevant to any mHealth or IoMT widget you create to assist you in identifying vulnerabilities associated with your PHI handling. The H.H.S. website contains an assessment instrument as well as extra risk analysis guidelines.

The Security Regulation states three layers of protection to be implemented:

• Administrative;
• Physical;
• Analytical;

The goal is for all three layers to be incorporated as a single coherent curriculum, but aspects of each stack can quickly intersect with others. The three layers are described below, with connections to the set norms for each:

• Administrative security involves the system security process, assigned security obligations, and workforce safety. Information sharing management, security education and awareness, security issue processes, emergency plans, assessment methods, business associate agreements, and other accommodations are also insured.
• Physical security is needed to defend electrical components, equipment, and information. It includes facility access controls, workstation use and safety, device and mainstream press controls, and tools
• Analytical security encrypts data used to regulate data access, compliance controls, authenticity, and message integrity.

The H.H.S. Office for Civil and Human Rights and the National Institute of Standards and Technology (NIST) have even created a “Crosswalk PDF” to help protected entities. This document assists in correlating the NIST Framework to Improve Critical Infrastructure Information Security (also known as the Cybersecurity Framework) with the HIPAA Security Rule and other security frameworks. HIPAA does not necessitate this, but it encourages all authorized access and their business associates to improve their information security programs.

Administrative Safeguards Requirements

Administrative protections are the building block of HIPAA compliance through assuring policies, procedures, and organizational design that protect PHI. Such requirements involve:

• Necessity of having a security officer to draft and put into place security policies;
• Conducting periodic security awareness training for everyone who handles PHI;
• Establishing clear-cut procedures for granting and withholding access to health information systems.

One big lie that we can dispel is the need for “HIPAA Certification”. However, various organizations may provide classes and coaching about “HIPAA Certification”. These are not a legal or officially enforced form of certification.

On the other hand, HIPAA audits are genuine and can be performed on any public body or former colleague. Impartial audits can cost more than $20,000. They are not needed, but they can help you identify gaps in your organization’s corporate compliance.

The HIPAA Journal offers the most detailed and user-friendly HIPAA Compliance software development criteria available to protect all coated entities ‘ or business associates’ degree preferences. Companies are not required to pay for or perform audits, which can cost more than $100,000 based on their comprehensiveness.

Physical Safeguards Implementation

Physical safeguards protect the physical devices, equipment, and facilities where electronic Protected Health Information is located. Included in these requirements are controlling physical access to where PHI is located, such as installing workstation security practices and procedures for controlling the disposal of devices and media containing health information. With regard to mobile applications, physical safeguards cover device management policies that dictate how mobile devices such as smartphones, tablets, and other mobile devices access and store PHI.

Organizations must implement:

• Facility access controls to limit physical access to rooms containing PHI;
• Workstation use controls to ensure that only authorized users can access health information systems;
• Disposal or reuse policies for electronic media.

Mobile device management is particularly pertinent to healthcare applications, and organizations must implement remote wipe capabilities, encryption standards for devices, and policies for the use of personal devices in health environments.

Breach Notification Procedures

HIPAA Breach Notification Rule imposes some requirements for the response and reporting of breaches of Protected Health Information. Organizations must have procedures in place for detecting, analyzing, and responding to potential breaches within deadlines. For breaches affecting 500+ individuals, covered entities must report breaches to the Department of Health and Human Services, affected individuals, and in some cases, the media within 60 days of discovery.

45 CFR 164.400-414 covers the legalese. “Comparable incident reporting provisions enacted and enforced by the Federal Trade Commission (F.T.C.) pertain to distributors of personal health information and their third-party partners, according to section 13407 of the HITECH Act,” according to the F.T.C.

2021 was a bad year for data breaches, with 45.9 million records breached. 2022 was worse, with 51.9 million records breached. However, 2023 smashed all previous records with an astonishing 168 million records exposed, stolen, or otherwise impermissibly disclosed.

Enforcement and Penalty Structure

The HIPAA Enforcement Rule establishes the penalty structure for violations and the enforcement mechanism used by the Office for Civil Rights. The fines range from $100 to $50,000 per violation, and the maximum annual penalties are up to $1.5 million per type of violation. Criminal penalties can be up to $250,000 fines and 10 years of prison time for willful violations.

Intentional HIPAA infringements carry criminal sanctions ranging from $50,000 to $250,000 and up to a year in prison. Falsely accessing or disseminating PHI can result in a 5-year prison sentence. If done with bad intentions or for personal gain, the verdict is increased to ten years.

The enforcement rule emphasizes the importance of demonstrating good faith efforts to comply with HIPAA requirements, including:

• Conducting regular risk assessments;
• Implementing appropriate safeguards;
• Maintaining detailed documentation of compliance efforts.

In the first half of 2024, the total amount of HIPAA settlements and civil monetary penalties in the United States was around $5.86 million. This figure has seen a significant decrease since 2018, when the highest amount of fines was imposed for HIPAA violations, $28.68 million.

How to Ensure HIPAA Compliance When Developing an Application

So, how to develop an application to ensure HIPAA compliance for medical apps? We recommend that you adhere to the following 6 steps. By the way, we have an article, “5-Step Guide to Healthcare Mobile Application Development”.

Conduct a Complete Risk Assessment

The foundation of HIPAA compliance for the development of medical apps is conducting a thorough risk analysis that identifies all the potential weaknesses in your application’s architecture, infrastructure, and business practices. The analysis must examine each aspect of how your app handles PHI, from data collection and processing to data storage and transmission. The risk analysis must identify specific threats to the confidentiality, integrity, and availability of PHI, and document the likelihood and potential impact of each identified risk.

Implement Data Encryption Standards

Mobile app HIPAA compliance is attained by putting in place strong encryption protocols that safeguard PHI in transit as well as at rest. Apps should use industry-standard encryption algorithms like AES-256 to store data and TLS 1.2 or greater to transmit data.

Database encryption must be performed at multiple levels, i.e., file-level, column-level, or transparent data encryption, depending upon the sensitivity of the data stored. The mobile applications must use secure communication protocols for API calls and data sync processes as well. Additionally, field-level encryption must be performed by applications for highly sensitive data elements such as social security numbers, medical record numbers, and other personally identifiable information.

Establish Access Controls and Authentication

Robust access controls are one of the most important aspects of HIPAA compliance for healthcare apps, requiring the implementation of user authentication systems that verify the identity of users before granting access to PHI. Multi-factor authentication must be implemented for all users accessing sensitive health information using the combination of:

• Something the user knows (password);
• Something they have (token or mobile device);
• Potentially something they are (biometric authentication).

We recommend that you read our article, “Top Automation Solutions that Improve Your Hospital”.

Apply Privacy-by-Default Architecture

This approach entails implementing data minimization principles in:

• Collecting only the PHI necessary for specific operations;
• Designing user interfaces that clearly communicate privacy settings and data usage;
• Ensuring that privacy protections remain intact even as the application evolves or expands.

Apps also need to implement privacy-strengthening technologies such as data anonymization and pseudonymization, where possible. By the way, if you plan to use cloud computing in healthcare, we also recommend applying a privacy-by-default design here.

Produce Comprehensive Audit Logging

Maintaining detailed audit logs is essential for demonstrating HIPAA compliance and detecting potential security incidents. Software programs must log all access to PHI, including user access, data modifications, system administration activities, and security events. Audit logs must capture sufficient detail to recreate user activity and identify potential security breaches or policy violations.

Audit log mechanisms must be accessible in a manner that renders them impervious to tampering or modification by an unauthorized entity, typically through the use of cryptographic hash functions or hardened log servers. Logs must be retained for the necessary period (typically six years) and must be readily accessible for compliance audits or incident investigations. Log analysis must be done on a periodic basis to identify anomalous trends or security breaches.

Implement Business Associate Agreements

When creating mobile applications, HIPAA compliance demands having proper business associate agreements (BAAs) in place with all third-party vendors that will have access to PHI. These agreements should state each party’s obligations for safeguarding PHI and include specific protections that need to be put in place. BAAs should cover data handling practices, security expectations, breach notification obligations, and data return or destruction obligations.

Application architecture needs to be built to minimize the third-party vendors who require access to PHI and, where required, limit that access to what is particularly required for that service. Third-party integrations should be thoroughly vetted to determine that they meet HIPAA security requirements, and ongoing monitoring should provide assurance of continued compliance with implemented controls.

Key Challenges in HIPAA Compliance When Developing an App

HIPAA compliance for healthcare applications always encounters challenges. Here are the most weighted challenges in our opinion.

Balancing User Experience and Security Requirements

Designers must keep very close to the lines of authentication flows that meet security requirements without overwhelming users with complicated processes. That entails:

• Installing adaptive authentication that fluctuates security requirements based on threat level;
• Providing clear feedback to users of security capabilities;
• Designing interfaces that make security behaviors an integral process rather than an intrusive one.

You must implement the security best practices without interfering with overall healthcare objectives.

Managing Complex Third-Party Integrations

Developers need to implement detailed vendor management procedures involving:

• HIPAA compliance audits;
• Business associate agreement negotiations;
• Continuous third-party security practice monitoring.

This takes considerable resources and know-how to analyze every vendor’s security controls, data handling practices, and breach response. Changes in third-party services also affect compliance status, necessitating ongoing monitoring and a fast reaction to ensure compliance.

Maintaining Cross-Platform Security Consistency

The challenge goes beyond technical deployment. You must ensure security policies and procedures are consistent across all platforms while being platform-specific. This involves:

• Handling encryption deployments that operate across different operating systems;
• Access controls ensure consistency of operation, no matter the user device;
• Audit logging features that ensure there is complete visibility on all platforms.

This is probably the hardest challenge in terms of ensuring HIPAA compliance for healthcare applications.

Keeping Current with Evolving Regulations

Development teams must create processes for monitoring regulatory updates, assessing their impact on existing applications, and updating as appropriate within compliance-restricted timeframes. That includes staying current with direction from the Department of Health and Human Services and monitoring enforcement action that provides indicators of expectations for compliance. You can also participate in industry forums discussing HIPAA interpretation and implementation concerns.

Managing Technical Debt and Legacy Systems

Most healthcare organizations currently have legacy systems in operation that may not have been developed with the current HIPAA requirements under consideration. The problem is to develop integration strategies that maintain HIPAA compliance within the confines of existing infrastructures.

This requires adding additional levels of security, developing custom interfaces compliant with current standards, or planning large-scale system modernization programs. The problem deepens when integrating different legacy systems, which possess different security options and constraints.

Operating complete HIPAA compliance requires significant resources like expert security talent, compliance tools, audit services, a proper tech stack, and ongoing monitoring capabilities. For the majority of development organizations, particularly small startups or small firms, allocating sufficient resources for compliance within aggressive development timelines and costs is a significant challenge.

We Can Help You Develop an App with HIPAA Compliance

At OS-System, we specialize in developing mobile apps HIPAA compliance solutions that balance robust security with intuitive user experiences. Our development team understands the unique challenges of healthcare application development, including the need to integrate with existing healthcare systems, manage complex data workflows, and maintain compliance across multiple platforms and deployment scenarios.

Choose OS-System for your next healthcare application project and benefit from our deep expertise in HIPAA compliance for healthcare applications. We combine technical excellence with regulatory knowledge to deliver applications that protect patient privacy, meet compliance requirements, and drive your business success in the competitive healthcare technology market. Contact us today!