Concept of Operations: Relating to the introduction of a Personally Controlled Electronic Health Record System
5.2.1 Legislative proposals to support the PCEHR SystemIf individuals, healthcare providers and healthcare organisations are to actively participate in the PCEHR System, there must be a high level of trust and confidence in its operation. A legislative framework that provides clear, transparent and flexible oversight of the operation of the system as it develops and evolves is required.
A Legislation Issues Paper has been developed which outlines the key legislative requirements for the operation of the PCEHR System and the rights and responsibilities of participants who use the system [DOHA2011b].
The proposals outlined in that paper propose that the legislative framework will:
- Establish arrangements for operating the PCEHR System.
- Establish processes for participation.
- Establish processes for enquiry and complaint.
- Recognise the risks that a PCEHR system will present.
- Recognise that there are existing regulatory frameworks in place to support the appropriate flow of health information for healthcare and other public interest purposes.
- Recognise that the PCEHR system will also be supported by other laws and through means other than legislation, for example standards and education.
The Legislation Issues Paper also highlights other applicable legislation and privacy laws. The Legislation Issues Paper proposes that the PCEHR legislative framework will generally integrate with, rather than override, existing statutory and service delivery regimes, wherever this is feasible for effective delivery of the PCEHR System. The Commonwealth will work with states and territories to identify any existing reporting or secrecy provisions that may impact on the operation of the PCEHR System.
It is proposed that sanctions would be included in PCEHR legislation covering matters related to inappropriate use of the PCEHR System by healthcare organisations, healthcare providers, portal providers, contracted service providers, repository operators and other parties. Matters related to cybercrime will also be considered.
Consultation on legislation issues closed on the 3rd of August 2011, and input from that process is being used to inform drafting of legislation.