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11/04/2024 
Tanvi Mishra
12 Mins to Read
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What is the role of GDPR and HIPAA compliances in healthcare app development?
The technological revolution has radically transformed the healthcare sector over the decade. The healthcare applications are revolutionizing patient care, streamlining administrative processes, and facilitating communication between patients and healthcare providers. However, amidst this revolution, ensuring the privacy and security of sensitive medical information is imperative. This is where regulations like the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA) shape the landscape of healthcare app development.
These regulations outline the legal obligations and principles to ensure the ethical handling of sensitive data. Developers must understand the significance of GDPR and HIPAA compliance to avoid severe legal repercussions.
In this context, this article delves into the multifaceted roles of GDPR and HIPAA compliance.
What is the GDPR Regulation?
European Union (EU) implemented General Data Protection Regulation (GDPR) in 2018, to protect patient data, maintain compliance, and establish transparency in an increasingly data-driven healthcare landscape. GDPR is effective within the EU and the European Economic Area (EEA). However, it applies to businesses within and outside the EU that handle the personal information of EU residents.
GDPR provides a framework for organizations to implement stringent data protection practices including data mapping, transparency, and data protection impact assessment. The primary objective of GDPR includes enhancing data subject rights, promoting free and fair data processing, ensuring transparency, and strengthening data security with prompt breach notification.
Data compliance with GDPR enhances customer relationships, avoids legal and reputational risks, and contributes to a safe privacy-conscious environment. Non-compliance can result in reputational damage along with legal and financial losses.
What is HIPAA Regulation?
The United States enacted the Health Insurance Portability and Accountability Act (HIPAA) in 1996 as a federal law to ensure the privacy and security of Protected Health Information (PHI). It comprises four primary rules: privacy, security, breach notification, and enforcement of HIPAA compliance. Primarily, it is divided into two sections: Title I and II. Title I covers portability and Title II covers accountability, it is meant for those in IT and healthcare administration. Anyone who uses patient information including organizations, hospitals, third-party billing services, or IT vendors, falls under the law’s umbrella.
To comply with the HIPAA security rule, it is important to ensure administrative measures like workforce training and risk analyses, physical safeguards like workplace access controls, and technical implementations including cybersecurity software controls.
Compliance with HIPAA ensures the protection of patient’s privacy and the security of their personal information. Non-compliance with HIPAA regulations can result in severe civil and criminal penalties.
Comparing GDPR vs HIPAA: Key Differences
GDPR and HIPAA are designed to protect individual data and privacy, but they are applicable in multiple contexts with different scopes. Let’s have a look at some of the key differences between GDPR and HIPAA:
Consent based for Data Processing
The GDPR requires organizations to get consent from data subjects for the processing of personal health information. Data subjects (individuals) have the right to withdraw their consent at any time. Individual must be informed about the use of their data and take affirmative action to demonstrate their consent.
HIPAA is less restrictive, covered entities (organizations, IT pros, etc.) are not required to get the subject’s consent before processing their data and disclosures of PHI (Protected Health Information) for transactions including payment, treatment, and healthcare operations.
Type of Data Covered
GDPR covers a wide range of personal data including names, addresses, email addresses, IP addresses, and more. It covers all types of personal data not just health-related data such as racial, ethnic, biometric, religious, or philosophical data.
HIPAA on the other hand focuses on protected health information (PHI), including data related to an individual’s past, present, or future mental and physical health, healthcare services received, or payment services.
Scope of Data Protection
GDPR’s scope of data protection includes automated or non-automated processing of the personal data of EU citizens subject to the GDPR, regardless of the processor’s location. EU citizens’ information is protected, always and everywhere.
HIPAA’s scope is limited to the covered entities operating in the US. It applies to healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates, that handle protected health information (PHI) in the United States.
Penalties and Enforcement
GDPR requires instant notification of data breaches within 72 hours of learning about the breach to the concerned supervisory authority. It imposes significant fines for non-compliance, which can be up to €20 million or 4% of the global annual revenue of the previous financial year, whichever is higher.
HIPAA violations can result in civil monetary penalties enforced by the Department of Health and Human Services (HHS). Penalties vary based on the severity of the violation and can range from $100 to $50,000 per violation, with a maximum annual penalty of $1.5 million for identical violations.
Cutting the complexity of GDPR compliance
To simplify the GDPR compliance it is important to manage its complexity effectively. Here are a few tips developers can follow to easily comply with GDPR.
- Understand the key objectives of GDPR which include obtaining consent for data processing, clear privacy notice, ensuring data subject rights, and notifying data breaches on time. Focus on this aspect and this will save you a lot of time.
- Identify high-risk areas and address them instantly. This might include assessing data collection, storage, and processing, as well as ensuring all the security measures are in place.
- Adopt a “data minimization” approach by only collecting information that is necessary for business. Avoid collecting and storing unnecessary data as it may pose a problem during assessment.
- Use available tools and resources to simplify GDPR compliance. Like data protection impact assessment templates, GDPR compliance software, and guidance documents provided by the authorities.
- Seek expert guidance from consultants or legal professionals with expertise in GDPR compliance. They will assist in navigating the complexities of the regulation and ensure the covered entities remain compliant.
Why is HIPAA compliance vital for medical apps?
These days HIPAA compliance is an essential part of the healthcare app development process. Medical apps need to meet legal requirements, protect patient privacy, build trust, manage risk, adhere to data security best practices, and avoid penalties.
Failure to comply with HIPAA compliance may result in severe financial penalties imposed by the Department of Health and Human Services (HHS). Ensuring HIPAA data protection brings financial stability and viability.
What does HIPAA compliance for health applications mean for developers?
HIPAA compliance in application development is essential to building trust among users and stakeholders. It ensures the integrity of individual data and upholds the reputation of the organizations involved in healthcare app development. Developers with a deep understanding of privacy and security regulations can only navigate through the complexity of HIPAA compliance.
Application developers must:
- Understand and comply with HIPAA’s privacy, security, and breach notification rules.
- Take a design approach to implement security from the outset of the development process.
- Conduct thorough risk analysis, ensure data encryption, and maintain comprehensive documentation.
- Practice expert tools and services to maintain compliance.
HIPAA compliance for mobile app development requires developers to protect PHI, implement robust security measures, adhere to HIPAA regulations, and maintain data compliance throughout the application lifecycle.
How to make a HIPAA-compliant App?
When developing a healthcare app it is mandatory to do thorough research and understand the privacy requirements outlined by HIPAA. This will save the developers and their organizations from legal hassles. Here are a few steps that will make any software dealing with PHI HIPAA-compliant:
Understand HIPAA requirements
Read everything about the data privacy regulations, particularly the security and privacy rules, which explain the requirements for protecting electronic protected health information (ePHI). Check out what types of data are considered ePHI, and understand security standards and privacy requirements.
Implement HIPAA as a service Backend
HIPAA compliance is not just confined to apps and software, but also the cloud services they connect to. The cloud providers must be HIPAA compliant. Thankfully, the major cloud providers offer HIPAA-compliant backends, such as AWS, Google Cloud Platform, Truevault, Aptible, etc.
Thorough assessment of patient data
It is important to check and analyze what types of data come under the purview of PHI. It is the first step of app development, to properly design the database. It is crucial for apps that use patient data to stay isolated and protected from other apps or tools. This will avoid keeping the patient data at risk.
Complete Encryption
Implement robust encryption techniques to protect PHI when stored on servers or devices and during transmission. Encryption is an integral part of healthcare mobile app development, so use industry-standard encryption algorithms and protocols.
Consult Expert for Guidance
Always consult an expert healthcare app developer, as he will have the expertise to audit and analyze your HIPAA-compliant preparedness. Besides this, consult with legal experts who specialize in healthcare law and HIPAA compliance. This will ensure the app meets all the legal practices and requirements.
Perform regular Audits and Assessments
Regularly audit and update the latest security patches. Keep track of PHI access, monitor any security vulnerabilities, and assess potential risks to ePHI. Update HIPAA compliance policies and procedures as needed. Address all breaches or threats promptly.
How to Make a GDPR-compliant healthcare app?
Developing a GDPR-compliant healthcare app involves adhering to the requirements mentioned in the General Data Protection Regulation. Here is a step-by-step guide on how to make a GDPR-compliant app:
Understand GDPR requirements
Build a solid understanding of GDPR which includes basic principles, rights of data subjects, and obligations of data processors. Learn the rules of data collection, storage, and processing, emphasizing transparency, and the right to be forgotten. Pay attention to the regulations concerning sensitive data under the GDPR.
Data Minimization and User Consent
When collecting data avoid unnecessary data, only collect health-related information that is important for providing the intended services. take valid consent from the users before collecting or processing their data. Users must know how their data will be used and will have the right to withdraw consent at any time.
Data Security and Integrity
Regularly update the app’s security protocols to safeguard personal information and address emerging threats. In the event of a data breach, notify the relevant supervisory authority and individuals without delay.
Legal Consultation
Legal experts will save you from unnecessary legal hassles. These experts specialize in data protection and GDPR compliance and will ensure that the healthcare app meets all legal requirements and best practices.
Regular compliance audits
Experts always suggest regularly auditing and assessing the ongoing compliance with GDPR requirements. Auditing includes data processing activities, updating privacy policies, and providing training to the employees on GDPR compliance.
Ten biggest GDPR fines of 2023
Data privacy is paramount and non-compliance can easily burn your pocket and reputation. Here is a list of the top 10 biggest GDPR fines and penalties of 2023:
- Meta Platforms Ireland Ltd.: EUR 390 million
- TikTok Ltd.: EUR 345 million
- Criteo: EUR 40 million
- TikTok: GBP 12.7 million
- TIM SpA: EUR 7.6 million
- WhatsApp Ireland Ltd.: EUR 5.5 million
- Clearview AI Inc.: EUR 5.2 million
- Spotify: EUR 4.9 million
- Trygg-Hans: EUR 3 million
