The HIPAA compliance software market, closely tied to how organizations implement, monitor, and enforce compliance, is projected to grow substantially, with an estimated CAGR of 10.2% from 2025 to 2032, and market value rising from roughly $950 million in 2025 to over $2.1 billion by 2032.
In the digital age of modern healthcare, it is no longer a choice but a necessity to develop a secure and compliant mobile application. Through the new digital tools implemented by healthcare providers, insurers, and tech companies, developers are forced to navigate a maze of legal, technical, and security requirements. When the team is oriented on mobile app development in UK and is aimed at the international healthcare clients or the US patient data, one of the most important standards will be identified: HIPAA compliance.
The Health Insurance Portability and Accountability Act (HIPAA) promotes the standard of the protection of the protected health information (PHI). Even though HIPAA is an American policy, the developers in the UK operating with the US partners, including telemedicine website solutions and wearable health apps, should be familiar with and apply HIPAA controls to safeguard the information, establish trust, and prevent expensive fines.
This final checklist includes information on what should be known and done by developers to create HIPAA-compliant mobile apps that are both safe and secure.
What Does HIPAA Mean and Why is it Important?
HIPAA regulates the creation, storage, transmission, and access of PHI. It applies to covered entities (healthcare providers, health plans, clearinghouses) and their business associates – such as app developers processing or transmitting PHI on behalf of a covered entity.
Violation of HIPAA may result in fines, prosecution, and negative publicity. The HIPAA knowledge of UK developers that deal with US health data is no longer a best practice, but a business necessity.
We will discuss the most critical aspects that your team will need to consider in order to attain compliance.
Know the HIPAA Security Rule
The HIPAA Security Rule is concerned with the protection of electronic PHI (ePHI), and the developers are required to implement three fundamental protections:
- Administrative safeguards
- Physical safeguards
- Technical safeguards
All layers have their own role in the protection of sensitive data throughout its lifecycle.
Make a HIPAA Risk Assessment
Risk assessment assists you in determining where ePHI fails. This involves:
- Data flow mapping (the flow of PHI in, out, and within the app)
- Determining possible threats and vulnerabilities
- Assessment of risk probability and effects
- Recording mitigation measures
Risk assessments should be conducted regularly, and your checklist modified every time you add features that may affect PHI.
Establish Effective Access Controls
HIPAA mandates access controls in a granular manner such that access and modification of ePHI are only controlled by authorized users.
Best practices include:
- Unique user IDs
- Role-based permissions
- Automatic session timeouts
- Multi-factor authentication (MFA)
Tight controls minimize the number of unauthorized access and minimize breaches.
Safe Authentication and Authorization
Authentication is used to identify the user, whereas authorization is used to determine user permissions.
To stay compliant:
- Enforce effective passwords (length, complexity, expiration)
- Introduce MFA (biometric, SMS codes, tokens)
- Record log-in attempts and indicate suspiciousness
- These prevent unauthorised access and promote the accountability principles of HIPAA
Encrypt ePHI End-to-End
HIPAA compliance is based on encryption. It makes sure that data cannot be read without the decryption key.
You should:
- Encrypt rest data (on devices, in databases).Secure data transfer (HTTPS/TLS)
- Use and transfer keys in a safe manner
- Encrypt with standard industry ciphers (e.g., AES-256)
Unless your application is encrypted, it might be compromised despite other protective measures.
“In healthcare app development, compliance isn’t just a checkbox, it’s the foundation of trust. Secure apps protect patient data, reduce risk, and enable innovation in digital health.”
– Muhammad Rashid, CTO at 8ration
Ensure Secure Data Storage
Mobile applications are likely to be stored locally,y and that creates more risks.
To protect ePHI:
- The storage of ePHI locally should be avoided unless there is an absolute necessity
- In case there is a need to store locally, encrypt it
- Store on secure frameworks provided by iOS/Android
- Do not back up to unsecured or third-party services
An effective approach to mitigate the effects of lost or stolen devices is proper storage practices.
Introduce Audit Control and Logging
HIPAA mandates the logs to indicate:
- Who accessed ePHI
- When they accessed it
- What they did
Ensure your audit system.
- Records all access and change activities
- Time-stamp the events correctly.
- Stores logs are stored separately and without using the app
- Tracks suspicious activities
The audit logs are essential in compliance reporting, incident response, and legal audits.
Develop Safeguarded Transfer Protocols
Information sent between the backend servers and the app should be secured.
Your app should:
- All connections should be made with HTTPS and TLS 1.2+
- Check in certificates to inhibit MITM
- Use fallback protocols that are not insecure
- The data are safeguarded by means of encrypted transmission between touchpoints
Design a Data Breach Response Plan
Compliance entails preparing to be the worst. Your breach response plan must:
- Establish the definition of a breach
- Allocate roles and responsibilities of the response
- Describe notification requirements (clients, authorities, partners)
- Incorporate methods of containing and examining the intrusion
An adequately laid plan reduces the harm and shows responsibility.
Sign Business Associate Agreements (BAAs)
In case your application involved PHI of a covered entity, you will need to sign a Business Associate Agreement (BAA). This legal contract:
- Specifies your role in PHI protection
- Allows disclosure and usage
- Information violates reporting deadlines
- Makes terms of insurance and liability
In the absence of a BAA, a covered entity is not at liberty to distribute PHI with your application.
Broader health IT security markets, which encompass cybersecurity measures essential for HIPAA compliance, are also growing fast. One forecast expects the global health IT security market to reach roughly $67.3 billion by 2034 from USD 16.5 billion in 2024, at a CAGR of about 15.1%, driven by regulatory pressures and escalating cyber threats.
Final Thoughts
HIPAA compliance is a technical and business requirement for mobile app developers who are in the healthcare market, and more so in the UK, working with American partners. This checklist is a road map to more than just secure, but trusted healthcare applications because of encryption and access controls, as well as detailed risk assessment and documentation.
Compliance and trust have a lot in common, as you work on the mobile strategy and entry into the markets, which require strict privacy measures. No matter what you are doing with iOS, you might be looking into app development for Android or simply looking at cross-platform solutions, a lifecycle approach that considers these HIPAA requirements early will save time, minimize risk, and open new prospects in the global digital health economy.
