Regulations and Privacy in Australia: Whether you are a health professional, software vendor or pharmacy, there are some important changes in the regulatory landscape for telehealth services. These changes will impact patients and the healthcare industry as a whole.
The Medical Board of Australia has proposed new guidelines that will prohibit doctors from prescribing medication via text, email or online to patients with whom they have never consulted. This could restrict access to millions of Australians, according to a spokesperson for Medmate.
Legality
In Australia, only registered health practitioners such as doctors, psychiatrists, dentists, nurse practitioners and midwives are allowed to write a prescription for you. This can be paper or digital and will vary from state to state.
Doctors and pharmacists are worried about the growing number of online services offering “instant” prescriptions that require patients to fill out a short digital questionnaire. This raises concerns about the safety and privacy of patients, according to peak doctor and pharmacy bodies.
The Medical Board of Australia has proposed new guidelines to restrict telehealth prescribing for patients with whom a doctor has never consulted. The Medical Board says it is a risk that a patient could be misdiagnosed or receive the wrong medicine.
Regulations
Electronic prescriptions in Australia are made possible by a number of regulations. These include the Medicines and Poisons Act 2019, supporting legislation, and regulations for systems that support electronic prescribing.
GPs are encouraged to consider using online scripting systems with their patients, taking into account the patient’s preferred prescription choice. This will help improve compliance, efficiency, and the safety of medication for patients.
The Australian Digital Health Agency (ADHA) has a register of conforming software products to ensure that software developers are creating software that is conformant with government legislation. This allows healthcare providers and vendors to understand which software companies are conformant.
The Australian Health Practitioner Regulation National Law requires medical records to be kept in a retrievable format and readable state for their minimum required retention period. They should be retained in a system that displays all NSW required details (see PRES-17). These requirements should be met by systems participating in the electronic prescription process.
Privacy
In Australia, the Privacy Act provides protection for people’s personal information. It applies to organisations (including body corporates) that collect, hold or use personal information.
There is also a new right under the Online Privacy Code to request access to or correction of their personal information. Organisations would have to take reasonable steps to comply with an individual’s request unless they are prohibited by law from doing so or there is an exception in the law.
It’s important to note that the extraterritorial reach of this change could have significant impact on global organizations who carry out business in Australia, or provide services to individuals in Australia, and who may have personal information about Australians.
As a result, it’s important to understand how the Online Privacy Code will apply to your organisation. This includes ensuring you have an updated and effective privacy policy in place and addressing your staff’s compliance with the policies. Using a privacy management solution is an easy and convenient way to ensure you are compliant with the law.
Impact
Electronic prescribing is part of an Australian Government budget measure to make the Pharmaceutical Benefits Scheme (PBS) more efficient, enhancing patient choice and improving compliance, efficiency, and drug safety.
While these measures have accelerated the delivery of electronic prescriptions, they do not fundamentally change the initial prescription and dispensing process in that patients can still choose which pharmacy they attend. They also maintain patient privacy and integrity of personal information by providing prescribers with a secure way to exchange prescriptions with pharmacies.
This is done by a Prescription Exchange Service (PES) system, which requires software vendors to meet certain requirements and meet specified security and privacy standards. PES systems are approved by the Commonwealth and are required to comply with the eRx Script Exchange or MediSecure conformance profile developed by the Australian Digital Health Agency.
As a result, there has been a rise in online prescription and dispensing services. One such service is Instant Scripts, which provides an authorised e-prescription service for consumers. However, the company says it is aware of concerns from the Medical Board of Australia about this platform.
Phenix Health delivers online health services 24/7 provided by Australian doctors and healthcare professionals.