Healthcare Data Information Protection in Different Countries

Different countries have their own requirements for protecting this kind of data. So it is important to determine the major regulations that apply to the type of software you develop and major points to pay attention to.

Here are the main healthcare data security regulations you need to follow while developing your own healthcare app:

HIPAA Regulations in the U.S. and Canada

The Health Insurance Portability and Accountability Act, or HIPAA, is the official document that takes under control the individual health information protection. Written in 1996, it is still applicable for various software utilized in the medical industry, such as email providers and Internet platforms, cloud services, and other digital resources where any personal information about the health status of patients is applied, transferred, or exchanged.

The main principles of these regulations are as follows

• Content encryption: Any electronic protected health information (ePHI) must be encrypted before the transmission.
• Storage encryption: The electronic patient PHI storage must be encrypted.
• Backup adapting: The data has to be recovered and restored if needed.
• Data access: Any ePHI is available for the authorized staff.
• Data integrity: The ePHI can’t be changed illegally.
• Secure disposal: The ePHI will be removed from the storage permanently if it is no longer needed.
• Business Associate Agreement: The most critical point is that the ePHI can be hosted only on services that have signed the Business Associate Agreement. If not, the data should be hosted on secure in-house servers.

PIPEDA in Canada

In 2000, Canada published an equivalent regulation — the Personal Information Protection and Electronic Documents Act (PIPEDA). The protected health information includes the general patient’s information like name/surname, personal ID, credit information, and medical records.

GDPR Regulations in Europe

If you are targeting the international market, it is important to comply with the requirements of the United Kingdom and European Union known as the General Data Protection Regulations. GDPR was adopted in 2018 to regulate data exchange between the EU members and promote the safety of each EU resident’s electronic personal healthcare information.

Non-EU countries, such as Serbia, Norway, or Iceland, have also accepted the GDPR or adjusted them for their respective healthcare sectors.

This system covers a broad range of software and has more general regulations than HIPAA’s. To get approval for a healthcare app in Europe, you should follow these regulations:

• Inform your clients. All the information about the data storage and transmission should be delivered to the users.
• Provide the reasons for data exchange.
• Get approval from the data owner.
• Anonymize the data collected.
• Provide access to the data owners.
• Notify the data owners about any breaches.
• Allow the data owners to withdraw their consent of personal data processing.
• Ensure secure data flow and exchange.
• Delete personal information upon request.

International Standards of Asia-Pacific Region

The medical information in this region is regulated by different laws, which are rather close to the GDPR but include each region’s regulatory requirements, enforcement, and export regulations.

Here is a list of countries and their personal health data rules, sorted by the level of regulation, starting from the highest:

• China — CyberSecurity Law
• South Korea — Personal Information Protection Act
• Taiwan — Personal Data Protection Act
• India — Digital Information Security in Healthcare Act
• Australia — Privacy Act

There are many things to consider to comply with the HIPAA regulations in the US, PIPEDA in Canada, GDPR in the EU, and so forth, before launching your own healthcare data security software. Of course, once built, the app should be improved on a regular basis to prevent third-party intervention.

If you need expert guidance or support in developing a secure healthcare app that meets these stringent regulations, contact us.