HIPAA, GDPR, & Other Compliance in Healthcare App Development

As the healthcare industry confidently masters the digital environment, guarding patient information becomes paramount. Safety measures are taken on the state and international levels alike. Compliance data standards dictate the appropriate implementation of relevant laws, industry regulations, and specific rules concerning how information is gathered, handled, and distributed during healthcare delivery. Sticking to these rules is crucial as it protects companies from legal risks and grants a safe space for users.

Since digital healthcare solutions face an elevating demand, regulatory requirements become more diverse and comprehensive. Various types of fraud  are common in this sphere. Thus, 92% of healthcare establishments suffered from data breaches in 2024. Such instances undermine digital health services, hence the multitude of existing and new healthcare laws intended to guard patient information.

Healthcare compliance standards like the Health Insurance Portability and Accountability Act (HIPAA) in the US, and the General Data Protection Regulation (GDPR) in the EU are conceived to fill the security gaps. They dictate which information needs safeguarding, which procedures to follow when operating data, and which penalties can be applied to those who don’t comply.

If you are planning to construct your own healthcare app, you should strictly adhere to the necessary regulations. Otherwise, legal and financial repercussions can be severe. 

Nevertheless, the rules are extensive, complicated, and continually altering, making compliance a challenging endeavor. We’ll examine the primary regulations and threats and suggest how to craft a product that conforms to the necessary standards.  

Why is healthcare compliance important in healthcare apps?

Healthcare companies today increasingly apply software applications to adjust to the needs and tendencies dictated by the modern world. The effects of tech progress, however, bring continually reinforcing healthcare compliance regulations that determine how the solutions should function, operate patient information, and connect to other systems.

Beyond being a necessary requirement, compliance in healthcare app development also witnesses provider’s trustworthiness and commitment to non-compromised quality and safety. It guides developers through sophisticated nuances of software products for individual well-being.

The importance of compliance in healthcare becomes evident as soon as we immerse ourselves in the details of regulations and software construction. The regulatory norms set high standards, dictating the ways to arrange the procedures, guarantee attention to detail, and ensure consistency across the entire development path. Failure to meet healthcare regulations can lead to considerable risks.

We’ll overview the fundamental aspects of why compliance is important in healthcare.

Potential compliance issues in healthcare 

Valuable patient information often becomes subject to thefts. The consequences? Million-dollar fines, numerous affected patients, costly lawsuits, and ruined reputations. In the harshest cases, non-compliance can lead to a healthcare provider closure or even imprisonment.

Instead, if you build a reliable healthcare app, you’ll be able to establish trust, which is crucial in medical services. Compliance in healthcare grants patients peace of mind when they entrust their personal information to medical advisors.

How regulations impact development, safety, and data handling

From the standpoint of software construction, compliance entails a range of strict rules. However, it also opens opportunities for businesses to present and promote their apps. So, what is healthcare compliance for entrepreneurs?

• A guaranteed market entry. In many regions, meeting the required norms ensures regulatory approval. This consent, in turn, allows entrepreneurs to introduce their products to the market.
• Optimized expenditures. Initial investments in compliance may appear substantial. However, they will repay later as your solution would be crafted according to high demands. This dwindles the risk of mistakes, revisions, and legal troubles. Furthermore, unified regulations expedite the development works and elevate their efficiency.
• Proven information safety. Regulatory standards dictate non-compromised safeguarding of individual data and grant the opportunity for patients to easily reach or update their information. This facilitates confidence in products that conform to legal regulations.

The growing demand for secure digital health solutions

The shift of healthcare services toward a digital environment reinvents the essence of delivering care. Modern users expect prompt, smart, and accessible solutions. According to McKinsey research, global investments in digital healthcare in recent years made about $57 billion. Therefore, innovative solutions become the driving force of care delivery. 

Apps for telemedicine, digital therapeutics, AI-enabled diagnostics, personalized monitoring, and other varieties of medical support are on the surge. Healthcare regulations and compliance requirements aim to unify the quality and safety criteria for myriads of digital products, making them precious, reliable, and patient-oriented assistants in medical care provision. 

Essential rules governing healthcare app development 

Now, let’s examine several fundamental healthcare compliance regulation examples that rule the medical app development landscape. We’ll look closer at each norm and how it affects software construction. 

HIPAA (Health Insurance Portability and Accountability Act - USA)

• What is it?

HIPAA dictates rules and policies to guard personal information in the U.S. HIPAA compliance in healthcare implies that all involved parties, including healthcare providers, insurers, and software vendors appropriately operate protected health information (PHI).

• Which entities need to adhere?

Medical advisors and institutions, insurers, and any other businesses that have access to PHI.

• Impact on app construction

Apps must include such functions as encryption, access administration, and audit trails for PHI. Consent should be required for any data-sharing action. Multi-factor authentication or other safe authentication methods are necessary.

• How to adhere?

Encrypt PHI during transmissions and at storage. Make sure your cloud storage is safe and conforms to HIPAA. User access must be strictly controlled.

GDPR (General Data Protection Regulation - EU)

• What is it?

GDPR regulates data confidentiality in the European Union, aiming to guarantee that individuals have comprehensive control over their data, including health records.

• Which entities need to adhere?

All firms dealing with the personal information of EU citizens. The location of a company doesn’t matter.

• Impact on app construction

To guarantee GDPR compliance, a healthcare app must include the user’s consent to accumulate and operate data. Individuals must obtain the opportunity to access their information effortlessly and modify or delete it if necessary. Non-compliance can cause significant fines.

• How to comply?

When crafting an app, arrange clear privacy policies and user consent procedures. Keep the acquired information safely with encryption and access administration. Empower patients to reach, change, or delete their data within the app.

PCI (Payment Card Industry Data Security Standard - Global)

• What is it?

PCI is a global security standard intended to safeguard users’ financial details. It focuses on secure payment processing. 

• Who needs to comply?

All healthcare solutions that handle credit/debit card payments. Patients can pay for consultations, prescriptions, etc.

• Impact on app construction

The financial aspect of healthcare support must also be fulfilled with the utmost safety to prevent fraudulent activities. The app must be compatible with PCI-compliant payment gateways, like PayPal.

• How to comply?

Users’ payment details should be kept outside the app. To guarantee safe transactions, apply encryption and tokenization. Keep a keen eye on security risks and regularly perform compliance audits.

PIPEDA (Personal Information Protection and Electronic Documents Act - Canada)

• What is it?

PIPEDA is a set of standards for guarding individual information, including healthcare data. It aims to guarantee that all information is gathered and operated in strict correspondence to laws.

• Which entities need to comply?

Businesses and healthcare organizations handling the confidential information of Canadian citizens.

• Impact on app development

Healthcare apps must include clearly established privacy policies and require user consent for any action with data. App users must have the right to request access to their information. If any data breach occurs, authorities and involved users must be notified.

• How to comply?

Clearly outline how patient information is gathered and used. Use reliable approaches to encryption and authentication. Develop clear notification procedures in case of data breaches.

MHRA (Medicines and Healthcare Products Regulatory Agency - UK)  

• What is it?

The MHRA is the regulatory body in the UK that controls the safety of medicines and medical devices. It ensures that the relevant products and services match safety, quality, and efficacy standards. According to the MHRA, all applications that qualify as medical devices must adhere to UK Medical Device Regulations.

• Who needs to comply?

Developers of medical apps that deal with health diagnostics, monitoring, or treatments. Besides, companies that create or sell medical software, AI-enabled health tools, or Software as a Medical Device in the UK.

• Impact on app development

First, app developers must identify whether their app falls under MHRA regulations, namely, qualifies as a medical device. If it does, it should undergo an approval procedure before launch. Furthermore, all medical applications must comply with UKCA marking.

• How to comply?

Define the risk classification of your app according to MHRA guidance. Then, undergo clinical validation for safety and effectiveness to get UKCA marking. The app must conform to cybersecurity standards for data protection. Finally, keep compliance documentation and be ready for audits.

NHS (National Health Service) Digital – UK

• What is it?

NHS Digital is another UK government body regulating digital health services. It provides data, digital services, and IT infrastructure for the National Health Service (NHS) and establishes standards for data security and interoperability for healthcare apps.

• Who needs to comply?

All medical apps that keep and operate NHS patient information. Software developers who work with NHS systems, electronic health records (EHR), or NHS APIs. Any other organization dealing with confidential patient data according to NHS regulations.

• Impact on app development

Apps must adhere to NHS Data Security and Protection Toolkit (DSPT) requirements. Developers need to provide secure integrations with NHS systems and guarantee a safe information exchange with NHS digital services.

• How to comply?

Primarily, developers should stick to NHS DSPT information security guidelines. To exchange data safely, implement FHIR (Fast Healthcare Interoperability Resources). Then, strictly follow UK GDPR and NHS patient confidentiality standards. Finally, do not overlook appropriate encryption, access controls, and audit logging.

HITECH (Health Information Technology for Economic and Clinical Health Act - USA)

• What is it?

HITECH is a kind of extension for HIPAA, introducing stricter security and breach notification rules and spurring the use of electronic health records.

• Who needs to comply?

Healthcare providers, insurers, and other organizations dealing with PHI.

• Impact on app development

This regulation sets higher penalties for security breaches. App owners and developers must keep this in mind, taking even stronger measures to enforce encryption and user access controls.

• How to comply?

Multi-layered authentication and strict encryption are obligatory. Regularly perform security checks and training and guarantee prompt reporting of PHI violations. 

What are the penalties for non-compliance?

Non-compliance in healthcare can lead to substantial negative consequences, which depend on several factors. Specifically, the responsibility levels are determined by the entity’s initial obligations, the type of violation, and the sanctions stipulated for non-compliance. 

In general, penalties include the following:

• Financial penalties. Non-compliance fines can reach millions of dollars, causing devastating effects on companies. Thus, GDPR non-compliance can result in up to €20 million or 4% of a firm’s annual revenue. Cerebral, Inc., a telehealth company, was found guilty of disclosing personal information in its marketing campaign and had to pay a $7 million fine.
• Legal actions. Apart from fines, failure to comply with regulations may lead to lawsuits, restrictions on operations, and even criminal liability. Overall, legal consequences can range from compensation claims to imprisonment of up to 10 years.
• Damage to reputation. Depending on the consequences of non-compliance, the company’s reputation can suffer. A lack of trust from patients and medical advisors is harmful for the further activities of a company that doesn’t stick to legal demands.

Non-compliance causes drastic consequences that threaten business stability. Moreover, the owners’ welfare can also be affected. Therefore, organizations delivering healthcare solutions should recognize the critical importance of adhering to regulatory rules. After all, the impact of compliance issues on the financial and legal aspects, as well as the overall well-being of businesses and their owners can be overwhelming.  

How to choose the right tech development partner

When selecting a tech development partner for your healthcare application, it’s critical to check compliance with all industry regulations your product falls under. We’ve compiled a list of fundamental steps to ensure the developer’s adherence to those rules.

• Evaluate their experience in healthcare projects. Confirm that the team has already dealt with healthcare apps and request the relevant case studies. Browse the previous clients’ feedback.
• Assess provider’s security and data protection measures. A reliable development firm would follow the industry’s best practices, including encryption, secure authentication, role-based access controls, and data anonymization. Ask how they implement API security, third-party integrations, and protection against cyber threats.
• Check whether compliance is outlined in legal agreements. All contracts and agreements should clearly state how patient data is collected, stored, processed, and protected. This should include a detailed description of data ownership, access permissions, and liability clauses. Confirm that data-keeping and deletion policies comply with local and international laws.  
• Perform regular performance audits and security checks. Your partner should be ready for regular security audits and risk assessments. Find out whether they stick to high security standards by fulfilling code reviews, vulnerability testing, and compliance weakness analysis.
• Ensure hosting & cloud storage compliance. Your cloud service provider must also comply with HIPAA (for the U.S.), GDPR (for the EU), PIPEDA (for Canada), or local healthcare laws and have certifications like ISO 27001, HITRUST, or SOC 2 to prove adherence to security standards.
• Study incident response policies. Ask a potential partner how they identify, report, and mitigate security violations. Check whether they have notification protocols for authorities and involved users. Ask if they deliver an ongoing observation for any security violations to respond and prevent them timely.

Entrusting your app development to a compliant and security-oriented tech partner will protect your business from penalties, reputational harm, and potential legal action.

Final word: How to maintain healthcare compliance in software development?

Digital health is a rapidly expanding sector that sets a massive demand for multiple types of healthcare applications. Entrepreneurs planning to join this trend must recognize what regulatory compliance in healthcare is and why it is so important for their businesses. 

We’ve outlined the fundamental regulations in healthcare app development, the risks and penalties for non-compliance, and the ways business owners can guarantee their products adhere to the required standards. 
SDA can become your trusted partner in crafting your software product. If you ask our experts, how can healthcare organizations ensure compliance with HIPAA regulations? We’ll provide a detailed checklist accompanied by our comments and recommendations.  

Contact us to discuss your project, and we’ll help you remedy risks, guard patient data, and guarantee that your healthcare app exhaustively matches legal and security standards.