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GDPR vs HIPAA: Key Differences and How to Achieve Data Compliance For Mobile Apps

Tapan Patel

Dec 23, 2021

7 min readLast Updated Dec 14, 2022

GDPR vs HIPAA: Key Differences

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Final Thoughts

As technology surrounds every part of our lives today, the questions about privacy regulations and security still concern the businesses dealing with personal data and information. Together, we can establish the fact that protecting personal information and data is critical, especially with varied accounts of data leaks across several industries.

In order to tackle them better, many international regulatory and governing entities have created a set of privacy laws, rules, and regulations. The US Health Insurance Portability and Accountability Act (HIPAA) and the General Data Protection Regulation Act (GDPR) are amongst the two most notable laws for mandating the protection of sensitive personal data.

There are a number of similarities between HIPAA and GDPR the first and foremost being their common principles of regulating personal information. This includes how the information is used, disclosed, maintained, and transferred. This makes it clear that both share the common goal of protecting an individual’s privacy. Yet despite their similarities there exist notable differences between the two.

In this article, we’ll take a look at both GDPR vs HIPPA, their differences, and the importance of GDPR vs. HIPAA for Digital Health Apps. However, the path to developing a complaint app requires one to leverage the knowledge of an expert software development company. But before jumping straight into it, let’s first take a look at what HIPAA and GDPR regulations are and their role in data protection.

What is the GDPR Regulation?

The European Union’s (EU) GDPR came into being on May 25, 2018, Although GDPR is a relatively new data security regulation it still has a broader data privacy compliance scope than HIPPA. This regulation requires businesses to protect personal data  (i.e., personally identifiable information/PII) including any information that can be used to identify an individual such as name, location, ID numbers against theft, fraud, or misuse of data. This regulation also works to protect the privacy of personal data even outside the EU and EEA areas.

GDPR gives all EU citizens the right and control over the use of all their personal data and information.

Who Must Comply with It?

  • Those businesses that are processing, holding, monitoring, and/or using the data of EU citizens even if they are not based in the EU.
  • Those who have their base of operations are in the EU itself.
  • And those offering goods or services to the people based in the EU.

Who must comply with GDPR

What Kind of Information is Protected under It?

  • Data includes personally identifiable data along with any data concerning health.
  • This also includes physical, genetic, economic, ethnic origin, political affiliations, religious beliefs, cultural or social identities, etc.

Also Read: 7 Tips to Ensure your Business is GDPR-compliant

What is HIPAA Regulation?

HIPPA as a data protection regulation goes way back to 1996. It was developed to protect an individual’s Personal Health Information (PHI) from those dealing with it regularly including US health care providers, health insurers, and other third-party organizations. There are a number of  Data Governance Procedures including areas of billing, patient history, admission, and administration. Under HIPPA all patients have the right to receive a copy of their PHI from healthcare organizations. All healthcare organizations are expected to prepare and comply with this regulation by having necessary data security standards intact to safeguard PHI data.

Who Must Comply with It?

  • HIPAA specifically applies to healthcare-covered entities and their business associates.
  • This includes any covered entity that provides treatment, support, payment, or operations in healthcare whether they are healthcare providers, health insurers, or health care centers, etc.
  • This also includes those business associates or organizations that create, store, or disclose PHI information for the respected healthcare entity.
Who Must Comply with HIPPA

What Kind of Information is Protected under It?

  • Any PHI or medical information that could be used to identify the individual receiving healthcare services.
  • This definition includes patient history, medical records, genetic history, billing information, insurance records, and others.

Comparing GDPR vs HIPPA: Key Differences

One fundamental difference between the two regulations is the type of information they focus on and the data scope. GDPR lays focus on protecting the PII of EU citizens and has a much broader scope when compared to HIPPA. Whereas the HIPPA Regulation on the other hand focuses on covered entities and their business associates looking after protecting PHI in the US.  However, those organizations handling EU patient information must also comply with GDPR. Now that we’ve understood the major aspect distinguishing the two, let’s outline all the key differences between GDPR vs HIPPA below:

  1. Consumer Consent

The GDRP Regulation protects its people from entering into any interaction without their privacy or consent. Under this regulation, explicit consent is a mandate for any PHI interaction or processing of data. This is also applicable to any marketing or advertising activities that take place between the healthcare provider and patients, for which direct consent must be expressed through any means, may that be through the phone or email stating their will to opt into the marketing communication.


On the other hand, under the HIPPA Regulation, healthcare providers do not explicitly ask for patient consent before disclosing PHI to another organization or business associates for treatment purposes. Treatment here is defined as the provision, monitoring, coordination, or management of a patient’s healthcare services by one or more healthcare providers.

2. Consumer Rights

The GDPR gives its data subjects full control over how they wish their personal and sensitive information to be used, stored, transmitted, and managed. This also includes individuals having the authority to use “Right to be Forgotten” when they wish for their data to be deleted or erased, even if the said data is being stored in the cloud or a third-party business associate. Individuals also have the right to be informed about terms and conditions, privacy policy, and cookies along with the right to update and access their personal data as and when necessary.


The HIPAA Regulation mentions no such rights that are available or given to data subjects apart from the right to access, update and move their healthcare information.

3. Data Breaches


The GDPR regulation states that organizations need to report data breaches affecting the rights of individuals as early as possible or within the first 72 hours of the breach being noted.


The HIPPA regulation requires organizations to report breaches impacting 500 individuals or more within 60 days. This also includes notifying the public of the breach. However, if there are fewer than 500 individuals, then the notification can go out annually.

4. Penalties


GDPR has two levels of fines for organizations that are not in compliance with the framework.

Lower Level: Up to €10 million (£8.5 million) or 2% of the worldwide annual revenue turnover of the previous financial year, whichever is higher in case of a breach.

Higher Level: Up to €20 million (£18 million) or 4% of the worldwide annual revenue turnover of the previous financial year, whichever is higher in case of a breach.


The HIPAA Regulation has different sets of fines for non-compliance and offenses based on the level of negligence, lack of awareness, and lack of due diligence which can range from $100 to $50,000 per violation with a maximum penalty of $1.5 million per year for repeat violations.

Organizations could also face potential criminal charges for fraud, false pretenses, and reasonable cause ranging from 1 year to 10 years and hefty penalties starting from $100,000 to $250,000.

Also Read:

The Approach Towards Achieving GDPR & HIPAA Data Privacy Compliance

GDPR and HIPAA Regulations are Data Privacy laws that are established to further strengthen the privacy, security, and integrity of sensitive personal information. Since their primary focus has similarities between HIPPA and GDPR, organizations complying with one regulation already come close to achieving the other. There are certain steps you must take to meet data privacy compliance and reduce your organization’s risk when treating EU citizens or residents. We suggest taking the following route to meet your compliance needs:

  1. Appoint a Data Protection Officer

Organizations looking to be GDPR compliant will need to get onboard experts from the cyber security industry having a thorough knowledge of the regulatory requirements. One who can monitor compliance and training as well as provide counsel on data protection. HIPPA in its case also makes a similar requirement to appoint a compliance officer having in-depth knowledge and understanding of HIPPA to oversee compliance procedures. Having people with the right skills and expertise onboard simplifies the Compliance process to a great deal.

2. Conduct Data Assessment

Both GDPR and HIPPA security rule states organizations conduct a data and risk assessment in order to get a helicopter view of the volume of sensitive data under their perusal. This helps organizations identify what type of data they are dealing with, the risk and security vulnerabilities attached with it, and how they can plan to safeguard such sensitive data. In the case of GDPR data includes any personal data whereas HIPPA pertains only to protect health information. A concrete risk assessment can present where your data resides and where it gets transferred including cloud applications, third-party servers, and shadow IT thereby enabling you to gain better control over its security and usage.

3. Establish Privacy Policy and Procedures

Organizations must comply with data privacy regulations in order to implement measures of privacy and security for the safe usage of sensitive data. This includes designing and developing certain data privacy policies and frameworks once the data assessment and risk evaluation are completed. This gives organizations a chance to identify gaps and therefore design policies to meet the goals of the compliance. By doing so, the risk of data breaches and privacy mishaps gets reduced thereby paving the way for a well-trusted patient care ecosystem.

Also Read: Complete HIPAA Compliance Checklist For Software Development

Final Thoughts

It is of utmost importance for organizations looking to become GDPR and HIPPA Compliant, especially for those in the healthcare sector and those aiming to create digital health apps to be familiar with the requirements of both these regulations. We hope this article helped you understand GDPR vs HIPPA and their scope much more clearly. On the lookout for a software development company to help you develop a GDPR and HIPPA compliant healthcare app? we’d be more than happy to help you out with the same. Partner with Third Rock Techkno and take out the stress of developing HIPPA and GDPR compliant apps.

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