The digital revolution has greatly influenced the healthcare industry. The number of IT systems in healthcare exceeds the number in any other sphere. But every system, connection, and employee with access to healthcare software is a cybersecurity risk.

In 2018, around 15 million patient healthcare records were compromised in over 500 data breaches. Halfway through 2019, the number was already 25 million records. The healthcare industry is seeing a steady increase in hacking. This situation is worrisome from the perspective of privacy and security in healthcare.

Why is cyber security in healthcare so important? Patient data includes personally identifiable information (names, dates of birth, addresses, bank account numbers) and medical information (ailments, disabilities, abuse, mental conditions). A data leak can damage the reputation of both doctors and their patients.

Improving the security of IT systems for storing and processing medical records reduces the risk of cyber attacks. Laws place protections around patient data and healthcare facilities, establishing security standards to protect medical records.

This article covers laws and safety measures for mHealth software. After reading it, you’ll know how to meet the compliance standards in healthcare around the globe. Plus, you’ll be able to determine whether data protection laws apply to your product.

Laws affecting healthcare startups

Though health app technologies are being deployed fast, the laws catch up.

HIPAA (US)

TheHealth Insurance Portability and Accountability Act, abbreviated as HIPAA, is a US law passed in 1996 guarantees healthcare privacy. Since its adoption, HIPAA has been modified twice.

HIPAA protection applies to anyone wanting to create a health-related application for the US market. The whole point is to ensure the security of users’ medical records.

Not all apps must follow HIPAA regulations. However, large platforms like Google Fit and HealthKit must comply because they allow users to share personal data with their physicians. If you’re developing a calorie counter, though, HIPAA compliance isn’t a must.

There are six steps to make your medical app HIPAA compliant:

  1. Use two-factor authentication to secure user accounts.
  2. Encrypt personal medical data at two points in time: when the data is collected on the device and when it’s transferred to the server.
  3. Add a feature to automatically log off users after a certain period of inactivity.
  4. Incorporate a wipe feature to erase personal data from a device before the data can be stolen and misused.
  5. Ensure regular app testing and updates.
  6. Offer automatic data restoration if a device is lost.

For more details on HIPAA, check out the explanatory video below.


To date, non-compliance penalties are up to $50,000 per violation. In the case of willful negligence, fines can be up to $1.5 million per violation.

GDPR (EU)

The General Data Protection Regulation (GDPR) was adopted in 2018 to coordinate the flow of data between EU Member States.

All health applications that collect the data of EU residents need to be GDPR compliant. Thus, entrepreneurs must ensure patient data security and privacy in their apps.

In years past, an app’s features were the key factor motivating a user to choose it. Today, it’s privacy and security in healthcare that matter to consumers. The GDPR understands this and makes entrepreneurs develop applications that respect user’s data.

The GDPR applies broadly and wasn’t tailored for mobile apps. That’s why its compliance regulations are more general than those of HIPAA. Under the GDPR, you must:

  1. Educate users about your data collection and handling processes.
  2. Notify users about the reasons for handling their data.
  3. Get prior consent to handle users’ data.
  4. Anonymize gathered records.
  5. Allow users to withdraw their consent to data processing.
  6. Notify users of any breaches.
  7. Give users access to records.
  8. Ensure safe data transfers across borders.
  9. Delete information upon request.

Details about the GDPR are explained in the video below.

Fines for GDPR non-compliance can reach €20 million, or 4% annual global turnover – whichever is higher.

Once the UK leaves the EU, the GDPR will still be harmonized with the Data Protection Act 2018. Thus, entrepreneurs in the post-Brexit UK will be subject to similar regulations.

Most non-EU countries in Europe have laws for information security and privacy in healthcare that are close to the GDPR. For example, Norway and Iceland have both accepted GDPR regulations. North Macedonia and Serbia have regulations harmonizing with the GDPR and are anticipated to pass data protection laws.

PIPEDA (Canada)

The Personal Information Protection and Electronic Documents Act (PIPEDA) came into effect in Canada in 2000. Under PIPEDA, entrepreneurs are responsible for gathering, processing, and disclosing personal records, including those collected via an app.

PIPEDA defines personal data to include general information like names, identification numbers, and credit and medical records.

PIPEDA is similar to GDPR and is much broader than HIPAA. To adhere to this law, you must:

  1. Hire a person responsible for PIPEDA compliance.
  2. Specify the reasons for collecting and processing user data.
  3. Notify users about the type of data collected.
  4. Inform users about how this data is processed.
  5. Get user consent for data collection and processing.
  6. Store collected data for a reasonable period.
  7. Delete data when it’s no longer needed.
  8. Protect data.
  9. Provide users with access to their data upon request.

PIPEDA doesn’t apply to all Canadian provinces. Each province can establish its own regulations concerning security and confidentiality in healthcare. However, these provincial laws need to reflect the federal law. Alberta, British Columbia, and Québec have their own provincial laws.

PIPEDA compliance details are well outlined in the video below.

If entrepreneurs are found to be knowingly in breach of PIPEDA requirements, they can be fined CAD $100,000 per violation.

Healthcare IT security standards in the Asia-Pacific region

The health app market in the Asia-Pacific region is developing rapidly. In China alone, 58% of patients share medical information with doctors from internet-connected devices. By comparison, in the UK and Germany, the figures are 26% and 12% respectively.

Federal personal data protection laws in Asia-Pacific countries are reminiscent of GDPR:

  1. Australia – Privacy Act
  2. India – Digital Information Security in Healthcare Act
  3. South Korea – Personal Information Protection Act
  4. China – Cyber Security Law
  5. Taiwan – Personal Data Protection Act.

This data protection heat map represents the stringency of personal information protection regimes across Asia-Pacific countries.

Healthcare standards
Source: hldataprotection.com

Four must-have measures for privacy and security in healthcare

It’s the responsibility of entrepreneurs and developers to work on securing mobile devices in healthcare from hackers. These four steps will help you create secure mobile apps.

Two-factor authentication

If your app has single-factor authentication (username/password), it’s easy to compromise accounts using a hacking script. Two-factor authentication (2FA) increases an app’s security asking a user for two factors of authentication when logging in.

Here are examples of 2FA:

  • Username/password + SMS code
  • Username/password + code sent via email
  • Username/password + biometric authentication (a fingerprint)

Getting around 2FA in your medical app requires time and resources on a hacker’s part.

SSL Technology

Encryption is a must for an mHealth app since it scrambles a user’s personal data. How does it work? A user’s personal medical information is vulnerable when being transmitted between an application and a server. Secure sockets layer (SSL) technology encrypts information transmitted between an app and a server. Even if this encrypted information is intercepted by a hacker, they won’t be able to use it.

Data wiping

Health apps store much health-related and other sensitive information. On the one hand, they offer convenience. But this convenience comes with vulnerability. A data wiping feature can make sure a user’s data is protected even if their phone is lost or stolen. To implement data wiping, an app can:

  • Log out a user after a certain period of inactivity
  • Keep information in an encrypted form
  • Perform an automatic data wipe after a certain number of unsuccessful login attempts

End users don’t want to find their medical information has been compromised. A data wiping feature gives them a sense of greater control over privacy, security, and confidentiality in the healthcare environment.

App testing and updates

At the stage of mHealth app testing, you can identify errors and bugs and determine if functionality works as expected, lowering the risk of intrusion. Among the best testing techniques you can rely on are network security testing, data security testing, and penetration testing.

Even with testing, security loopholes can be discovered after an app enters the market. Once loopholes are detected, updates need to be pushed to users. If exploited, unpatched vulnerabilities can lead to the theft of medical data, which can be used to commit identity theft and fraud.

Must your mHealth app comply with patient privacy laws?

mHealth apps can be divided into subjects and non-subjects to patient privacy regulations. To know if you need to strictly comply with the requirements of HIPAA, GDPR, PIPEDA, or other laws, check out the table below.

SubjectsNon-subjects
Monitoring apps for chronic conditions like high/low blood pressure, diabetes, and cancer.Patient medical education apps with useful articles on wellness and healthy living.
SubjectsWomen’s health apps for pregnancy tracking, natal care, and appointment scheduling.Reminder apps that encourage healthy habits like drinking water.
SubjectsOutpatient care apps to provide functionality for physicians and patients, assign medications, and track adherence to treatment plans.Non-subjectsHealth and fitness apps with exercise programs for personal goals.
SubjectsMobile medication trackers to track prescription regimes.Non-subjectsDieting (weight loss) apps with calorie counters.
SubjectsMobile clinical assistants to provide access to personal health data, test results, information on symptoms, and electronic charts.Non-subjectsSleep, meditation, and yoga apps for facilitating healthy sleep and workouts for the body and mind.
SubjectsDoctor appointment apps to notify patients about changes to appointment times.Professional networking apps for healthcare providers to connect and exchange knowledge.
SubjectsTelehealth mobile apps (doctor-on-demand) for online doctor visits and consultations.Non-subjectsMedical reference apps to provide doctors with information regarding drugs or diseases.
SubjectsRehabilitation treatment apps to provide goals and precautions for every phase of recovery.Non-subjectsGeneral hospital apps that include a virtual tour around a hospital, a list of services and doctors, their availability, etc.

Whether you’re building a health app for hospital use or for individuals looking to be proactive about their own care, you should entrust your app to an expert team. If you have a general idea and need assistance, contact us. Our developers will gladly provide a rough time and cost estimate and guide you through the process of app development for your project.