Healthcare apps hold sensitive information like names, addresses, medical histories, and test results. If user data leaks out, it can put people at risk. Criminals can use this information for fraud, and some people may even face discrimination because of what gets exposed. For US businesses planning to expand into Australia, it’s important to recognize that Australian privacy laws are just as strict — if not stricter — than HIPAA in the US.

Adapting your approach to healthcare data security and privacy isn’t just about following another set of regulations; it’s about building trust with a new audience that values data protection and transparency. In this article, we’ll explain the differences between the US and Australian healthcare laws and share insights into building healthcare apps compliant with the necessary regulations.

Healthcare laws in the USA: HIPAA

HIPAA stands for the Health Insurance Portability and Accountability Act. This law protects patient data in the United States. HIPAA compliance means your app or system meets strict standards for storing, using, and sharing sensitive health information. Every company that handles medical data in the U.S. must know and follow HIPAA law to keep patient information safe.

Key rules

HIPAA regulations set out several important rules that protect patient information in the U.S. Following these rules is crucial for HIPAA compliance.

The HIPAA Privacy Rule tells healthcare organizations how they can use and share patient data. This rule defines what counts as individually identifiable health information and sets limits on sharing it without patient permission. Under the rule, patients can review, request copies of their health records, and ask to correct their information.

The HIPAA Security Rule focuses on electronic protected health information (ePHI). It requires you to set up safeguards to protect ePHI from threats like hacking or theft. This rule details how you must store, send, and access electronic health records on your systems.

This rule is another key part of HIPAA regulations. It says you must tell affected patients and government officials if their health information gets exposed in a data breach. It requires quick and clear reporting.

It expands HIPAA regulations to cover business associates, not just healthcare providers. This means any third-party company that handles health data must also follow HIPAA compliance. The rule also gives patients more rights over their health records and increases penalties for non-compliance.

The HIPAA Enforcement Rule explains how the government checks for violations of HIPAA rules. It also outlines the penalties for breaking HIPAA law, which can include large fines.

The HITECH Act (Health Information Technology for Economic and Clinical Health Act) supports the adoption of electronic health records and strengthens HIPAA requirements, especially around data security and breach reporting. The act requires stricter enforcement and higher penalties for violations. It encourages all healthcare providers to use technology that keeps individually identifiable health information secure.

Consequences of non-compliance

A HIPAA violation can lead to serious problems for any company handling health data. The U.S. Department of Health and Human Services (HHS) enforces HIPAA compliance and makes sure businesses follow the law. The Office for Civil Rights (OCR), a part of HHS, investigates each case of a possible HIPAA violation.

If your business fails to meet HIPAA compliance, you can face heavy fines. The cost depends on the type and cause of the violation. Sometimes fines reach millions of dollars, especially if the breach affects many people or a company ignores repeated warnings. In some cases, breaking HIPAA regulations can also lead to lawsuits from patients or even criminal charges.

Healthcare laws in Australia

Many U.S. businesses ask about "HIPAA Australia," but the country has its own set of laws to protect health information and patient data. The main law is the Privacy Act 1988, which sets rules for healthcare providers and businesses that handle personal data.

Key rules

In Australia, several laws and agencies work together to protect health information and patient privacy. While there is no "HIPAA Australia" law, these rules set strict requirements for how healthcare providers manage and use patient data.

The Privacy Act is the main law controlling how organizations handle personal information, including healthcare data. The APPs are 13 rules that cover the collection, storage, use, and sharing of personal data. Patient health information is seen as "sensitive," so the law sets even stronger rules for it. For example, healthcare providers must collect health data fairly, keep it secure, inform patients how their data will be used, and only share it with consent or when the law requires. The Office of the Australian Information Commissioner (OAIC) makes sure businesses and healthcare providers follow these rules. The OAIC handles complaints and investigates possible breaches of patient privacy.

This law governs Australia's national digital health record system, My Health Record. Every Australian gets a digital health record unless they choose to opt out. The Act sets out strict access and usage rules to make sure only authorized people and organizations can see or use a patient's health data. Patients control who can access their information, and there are strong safeguards to protect patient privacy.

ADHA leads the development of national digital health systems and standards in Australia. It builds and manages the digital infrastructure, such as e-prescribing systems, and sets technical and security standards that software developers and healthcare providers must follow.

TGA regulates medical devices in Australia, including software used for medical purposes — known as Software as a Medical Device. If your application diagnoses, treats, or monitors health conditions, TGA may require registration, safety testing, or special labeling.

In addition to federal rules, individual states and territories in Australia can set extra privacy laws and requirements for health information. Some rules may be stricter, so healthcare providers and businesses must check both national and local regulations as they handle health data.

In addition to federal rules, individual states and territories in Australia can set extra privacy laws and requirements for health information. Some rules may be stricter, so healthcare providers and businesses must check both national and local regulations as they handle health data.

Breaking Australian healthcare rules brings serious consequences for any healthcare provider or business. If your business does not protect patient data, ignores privacy rights, or fails to notify about a breach, the OAIC may launch an investigation. The OAIC can order you to fix your processes, issue a public apology, or even pay compensation to affected individuals.

Financial penalties for violating the Privacy Act can be large. Serious or repeated failures to secure health information can lead to fines of up to several million dollars. Besides fines, you risk lawsuits from patients whose protected health information has been exposed or misused. Your reputation as a trustworthy healthcare provider can also suffer permanent damage, making it hard to keep or grow your business in the healthcare sector.

HIPAA vs Australia healthcare laws differences

When looking at HIPAA vs Australia healthcare laws, you will notice some major differences in how each country manages and protects patient data. HIPAA is a U.S. law that mainly focuses on protecting medical information handled by healthcare providers, health insurance providers, and related organizations. It sets strict rules and definitions for protected health information, and has special sections on civil rights in healthcare and the responsibilities of human services.

In Australia, there is no direct “HIPAA Australia” law. Instead, the Privacy Act and the Australian Privacy Principles form the core legal framework, setting requirements for all organizations that handle health data, including businesses, government agencies, and healthcare providers. These rules address everything from consent to cross-border transfers of patient data.

While both systems aim to ensure high standards for protecting medical information, the details of compliance, the definitions of covered data, and enforcement mechanisms can be quite different.

How to build healthcare apps in compliance with the laws

Building health care apps that are HIPAA compliant and meet Australia’s Privacy Act requirements is essential for healthcare entities who work with patient data and public health services. To ensure proper healthcare data security and legal compliance, you must apply best practices from the start and account for different regulations.

Begin with compliance by design — build the standards into your app from the first day of development. This means defining how your system will collect, store, and protect health data and health records according to both HIPAA and Australian privacy laws. Set up clear ways to classify and secure personal health information, and regularly check your security setup for weaknesses.

Create adaptable solutions for getting and managing patient consent, tailored to each region’s laws. For HIPAA, healthcare providers must document patient permissions for sharing medical information. In Australia, consent has to be voluntary, clear, and informed under the Privacy Act.

Invest in strong cybersecurity measures that go beyond minimal requirements. Use encryption for healthcare data in transit and at rest, and set up access controls so only authorized healthcare professionals and staff can see sensitive data. Regularly test your systems and respond quickly to any threats or incidents.

Design your solution to work smoothly with other systems and national platforms. For example, in the U.S., your software should integrate with EHRs to support healthcare entities and public health reporting. In Australia, consider integration with My Health Record and other local health data platforms. This ensures health data can flow where needed — improving care while keeping data safe.

If your app may serve users in several countries, including the European region, you must consider GDPR compliance (General Data Protection Regulation) as well. Use a common set of security best practices, keep clear records of your data handling, and stay updated about regulatory changes in every region where your users live.

At Ronas IT, we have experience in building software in compliance with diverse regulations, including HIPAA and Privacy Act. If you’re interested in creating healthcare software and need a development partner, we can help you with analytics, UI/UX design, web and mobile development, and ongoing maintenance.

This platform lets patients upload their lab test results, store them securely, view personalized health reports, and connect with healthcare professionals for advice. Healthcare businesses can offer the same services to their clients. Because we handle sensitive medical information, we embedded HIPAA compliance into the app from the very start. This included two-factor authentication, secure cloud storage, data encryption, robust access controls, automated database backups, detailed activity alerts, and automatic logout features.

This is an eco cosmetics marketplace mobile app for the Australian market, connecting consumers with local manufacturers of organic and cruelty-free cosmetics. To comply with Australia’s Privacy Act and local security standards, we prioritized data protection and user privacy at every stage of development. Our team implemented strong data encryption, secure cloud storage on AWS S3, and strict access control mechanisms to protect users’ personal information. Consent management was built into the onboarding flow, ensuring transparency and voluntary consent when collecting and processing personal data. We chose Stripe Connect for secure payments and seamless Know Your Business (KYB) procedures, eliminating the need to store sensitive seller documents on our own servers.

To conclude

Expanding your healthcare business into Australia requires more than just changing your marketing approach — it means understanding and adapting to a different legal environment. While HIPAA and Australian laws like the Privacy Act share the goal of keeping health information secure, they differ in scope, enforcement, and the details of compliance. U.S. companies must pay close attention to local requirements for consent, breach notifications, and cross-border data transfers. By putting patient privacy first and designing your healthcare solutions with compliance built in from the start, you not only avoid costly legal issues and fines but also build trust with your new audience. Working with experienced developers who understand both HIPAA and Australian regulations can make your expansion smooth, secure, and successful.