Ensuring GDPR Compliance in HealthTech: What You Need to Know

HealthTech applications handle sensitive data, such as digital health records, biometric identifiers, genetic profiles, and psychological details. Considering the deeply personal nature of this data, privacy is critical.

Businesses and organizations in the healthcare industry must find ways to protect their patients’ and customers’ information from malicious agents and hackers. Failure to do so will lead to reputational damage and legal fines.

To help companies steer the right way, governing bodies have drafted and enforced several regulatory frameworks.

One significant framework that governs data privacy across Europe is the General Data Protection Regulation (GDPR). It defines guidelines for data collection, storage, processing, and sharing.

Moreover, GDPR has special sections dedicated to health data to ensure responsible HealthTech application development.

Now, if you consider developing a digital solution for healthcare professionals, GDPR should influence your product design, data architecture, user experience, and operational policies.

Regardless of your wellness services, whether they are meditation apps or prescription management tools, you must adopt a privacy-first approach.

In this article, let’s understand GDPR in the context of HealthTech applications by looking at the framework, its principles, and how they can be implemented while building software.

What is GDPR in HealthTech?

The General Data Protection Regulation (GDPR) governs how businesses handle the personal data of European Union (EU) residents. It has comprehensive directives for organizations that determine how data can be gathered, used, and managed.

The regulatory framework has a special category for health data featuring stricter rules, given the nature of the information. These sections also clarify how to apply the principles, which we discuss further in this article.

Health data refers to any information you collect from your customers or users that can provide insights into their physical or mental health. Some examples of health data include vaccination histories, diagnostic results, biometric data, genetic markers, and disabilities.

The GDPR also mentions that data collected by wellness or fitness apps, such as heart rate or sleep patterns, can qualify as health data as well.

Apart from smartphone applications, there are other tools and means that allow businesses in the healthcare industry to collect personal information. Electronic health record (EHR) systems, telemedicine services, wearables, and mental health chatbots, to name a few.

Finally, the data privacy regulatory framework also highlights the importance of adhering to the special category laws for HealthTech application owners and vendors.

Why HealthTech Applications Should Be GDPR Compliant?

There are six advantages of building HealthTech applications that adhere to GDPR guidelines:

1. Protect Sensitive Data: The GDPR in HealthTech ensures that developers build applications responsibly and equip them with security features that minimize the likelihood of a breach. It will direct you to develop apps that have built-in data encryption, multi-factor authentication (MFA), etc., capabilities.
2. Empower Users and Shift Control: The customers or patients should own their data in the HealthTech applications. GDPR allows them to access, edit, or delete their health data through online portals and digital platforms. It mandates consent mechanisms, access rights, and data privacy awareness.
3. Avoid Hefty Legal Fines: As per the regulations, companies may pay up to €20 million or 4% of their annual global turnover, whichever is higher. If you are violating, knowingly or unknowingly, a law from within the GDPR, you may get fined. It can happen even if you protect your customers’ or patients’ healthcare information.
4. Build Trust Among Stakeholders: Healthcare professionals, business partners, vendors, customers, patients, and users should have faith in your solutions. You can easily earn that trust by adding the “GDPR Compliant” badge to your homepage, which boosts your authority in the industry.
5. Secure Data Transfers Across Borders: Your customers may travel and might need their latest health data. GDPR in HealthTech facilitates secure international data transfers, particularly within the EU and with countries recognized as having adequate protections. This is also essential if you are delivering global HealthTech solutions to diverse populations.
6. Promote Transparency and Accountability: Customers and patients should know that you store their data transparently, not in a black box. They should know what information you collect and how you manage it. Moreover, GDPR pushes organizations to take responsibility for handling the entire healthcare data lifecycle and build ethical and secure technologies.

Simply put, for HealthTech companies, GDPR compliance is a foundational requirement for sustainable innoKey GDPR Principles in HealthTech

You can consolidate the GDPR sections on health data handling into three essential principles. Let’s look at what they are and how to put them into practice.

1. Data Minimization and Purpose Limitation

Data minimization refers to the practice of collecting only the relevant data required for the task at hand. It protects users, customers, and patients from unnecessary exposure of their sensitive health data.

Purpose limitation enforces data minimization. It ensures that you use the collected data for its original purpose. This is pivotal for preventing data misuse and encouraging the timely erasure of sensitive information.

To implement this principle when developing a HealthTech application, you can start by defining the clear use cases for each data point collected based on your value proposition.

For instance, if your app tracks sleep cycles, it shouldn’t ask for geographical location. Use the collected information solely to help the user manage their sleep, and avoid any other applications.

Your team should follow this practice during the product discovery phase of HealthTech application development. Also, map health data flows to visualize and streamline management throughout the entire lifecycle.

2. Storage Limitation and Accuracy

Storage limitation emphasizes deleting or discarding the healthcare data if it’s no longer in use.

Let’s say one of your users has deactivated their account from your fitness application. This GDPR in HealthTech principle necessitates that you respect their decision and erase their information from your cloud servers.

Accuracy ensures that the data is up-to-date and reliable. In other words, healthcare professionals can leverage it confidently to make diagnoses or wellness decisions and recommendations.

Furthermore, storage limitation enhances accuracy by eliminating clutter in your organizational records. There is little overlap or confusion when accessing patient data, leading to improved service offerings.

You can put it into action by establishing data retention policies that align with medical or legal requirements when designing your HealthTech application. Another option is to modernize existing healthcare tools by adding features that enhance GDPR compliance.

Time- or behavior-based triggers, such as deleting a record after a certain period, can help limit health data storage and enhance accuracy.

3. Accountability and Transparency

The third principle requires you to take responsibility for your customers’ or patients’ data after collecting it. There are two key actions here:

1. Demonstrate GDPR compliance through documented policies, certifications, badges, training programs, and user controls.
2. Be open about how you are collecting health data, the rights of the subjects, and what you plan on doing with it.

Furthermore, HealthTech applications should record data processing logs and go through Data Protection Impact Assessments (DPIAs). DPIAs conduct in-depth audits of your health data management processes to identify and minimize privacy risks.

User-facing privacy policies should be straightforward and accessible to establish trust and decrease the chances of future conflicts. Additionally, if your core operations involve large-scale processing of sensitive health data, consider partnering with a Data Protection Officer (DPO) to receive practical guidance.

Designers can put accountability and transparency into practice through intuitive interfaces and privacy-aware user journeys. This makes it easier for you to communicate with your customers and patients, ensuring your HealthTech application remains GDPR compliant.

Legal Considerations for HealthTech Applications

When developing a GDPR-compliant HealthTech application, account for the following legal considerations in the design phase. This will establish a solid, compliant foundation for providing quality digital healthcare services.

Explicit Consent

Your customers, patients, and users should provide informed, specific, unambiguous, and freely given consent. Additionally, the HealthTech application should clearly relay what data it collects, why it collects it, and how it will use it.

Here, thoughtful user experience (UX) design can help comply with GDPR health data consent regulations. It’s better to avoid pre-ticked boxes or bundled consents to provide freedom of choice.

Moreover, the users should be able to give or withdraw consent easily, with visual cues guiding them through the process.

Other Legal Grounds for Health Data Processing

Health has a broader societal impact. Due to this, GDPR in HealthTech recognizes other lawful grounds where you can process healthcare data without explicit consent:

1. Public Interest in Public Health: Events such as pandemics, like COVID-19, and disease surveillance for tracking infection rates.
2. Vital Interests: This applies when clinicians need crucial data to save a life, such as during emergency health conditions when obtaining verbal consent is difficult.
3. Scientific Research: Some exceptional medical cases, under additional safeguards and approval from government bodies, allow data processing without consent.

Keep in mind that the grounds above occur rarely. It is best practice to take permission from your legal, medical, and IT compliance teams before using data for diagnostic or predictive analyses.

Rights of Data Subjects

The GDPR framework gives the data subjects, your users, several rights to control their information in your HealthTech application:

• Right to Access: The freedom to view health data through a dedicated profile or account.
• Right to Rectification: Users can modify recorded information on demand to ensure correctness and timeliness.
• Right to Erasure: Also known as the “right to be forgotten,” it enables your customers to delete their records from your databases.
• Right to Portability: The users can receive their health data in a structured, machine-readable format.

How to Build GDPR-Compliant HealthTech Applications?

From ideation and roadmapping to testing and release, your HealthTech application development team should focus on three aspects to adhere to GDPR regulations.

Data Protection by Design and by Default

The entire user journey in your healthcare software should integrate GDPR privacy directives.

For instance, as soon as a user signs up, the interface should ask for consent. The forms should be clear and contextual. Create an onboarding process that takes the new customers through each step.

Additional operations, such as managing permissions and modifying details, should also be streamlined. Users should be able to exercise their GDPR-specific health data rights effortlessly.

Toggle permissions (opt-in or opt-out), profiles with an edit option, and just-in-time (JIT) disclosures can help empower users by transferring control and providing relevant updates. It’s equally crucial to avoid dark patterns that can potentially mislead users through obscure choices.

Technical Safeguards

GDPR in HealthTech requires that the data pipelines in your application encrypt the information collected, both in transit and at rest. This, along with a secure cloud storage infrastructure, is pivotal in preventing unauthorized access at all times.

Another effective technical safeguard is MFA, which verifies your customers’ or patients’ identity in two or more steps. Usually, it’s something they know (password or PIN) and something they have (biometric or physical key).

To take it a step further, practices like pseudonymization and anonymization can help. These practices replace personal identifiers with codes and eliminate any chances of jeopardizing the user’s digital privacy and safety.

It’s advantageous to place such technical safeguards when developing the solution itself. This makes GDPR compliance for your HealthTech application easier.

Organizational Safeguards

The final component of GDPR compliance is people. The employees and team members handling the data should be aware of the applicable data privacy regulations, including GDPR.

You should ensure they get appropriate training to follow the relevant security protocols during HealthTech app development and health data handling. Establish strict access controls to prevent unauthorized access to sensitive data.

Moreover, routine audits can help identify gaps in compliance. This is especially important for healthcare businesses that must navigate both GDPR and HIPAA, which share similar digital safety goals but differ in their implementation.

SoluteLabs Can Develop GDPR-Compliant HealthTech Applications for You!

Building a GDPR-compliant HealthTech application can be challenging. From gaining relevant knowledge about the laws and fostering a user-centric culture to integrating GDPR directives at each stage of software development, this can be a complex process.

A better alternative is to partner with experienced professionals who can build the app or platform for you while you focus on delivering excellent healthcare services.

SoluteLabs, with over a decade of experience, specializes in developing secure and compliant digital health solutions.

Our team has worked with leading healthcare organizations, such as Roche and Tata 1mg, delivering custom-built, GDPR-compliant HealthTech solutions.

Whether it is product discovery, app design, software development, cloud architecture management, or digital transformation, we can help you all the way.

Ready to deliver a HealthTech application that stands out?

Let’s talk.