2010-2011-2012

 

The Parliament of the

Commonwealth of Australia

 

HOUSE OF REPRESENTATIVES

 

 

 

 

As passed by both Houses

 

 

 

 

 

 

 

 

 

Personally Controlled Electronic Health Records Bill 2012

 

No.      , 2012

 

 

 

 

 

A Bill for an Act to provide for a system of access to electronic health records, and for related purposes

   

   

   

Contents

Part 1—Preliminary                                                                                                              1

1............ Short title............................................................................................. 1

2............ Commencement................................................................................... 2

3............ Object of Act....................................................................................... 2

4............ Simplified outline of Act..................................................................... 3

5............ Definitions.......................................................................................... 4

6............ Definition of authorised representative of a consumer..................... 13

7............ Definition of nominated representative of a consumer..................... 15

8............ Things done etc. under provisions of other Acts............................... 16

9............ Definition of identifying information ................................................. 17

10.......... Definition of shared health summary ............................................... 18

11.......... Act to bind the Crown....................................................................... 18

12.......... Concurrent operation of State laws................................................... 18

13.......... External Territories............................................................................ 19

13A....... System Operator may arrange for use of computer programs to make decisions     19

Part 2—The System Operator, advisory bodies and other matters       20

Division 1—System Operator                                                                                 20

14.......... Identity of the System Operator........................................................ 20

15.......... Functions of the System Operator..................................................... 20

16.......... System Operator to have regard to advisory bodies’ advice etc........ 22

17.......... Retention of records uploaded to National Repositories Service....... 22

Division 2—Jurisdictional advisory committee                                            23

18.......... Establishment, functions and status of the jurisdictional advisory committee           23

19.......... Membership of the jurisdictional advisory committee....................... 23

20.......... Termination of appointment of members of the jurisdictional advisory committee   24

21.......... Substitute members of the jurisdictional advisory committee............ 24

22.......... Application of the Remuneration Tribunal Act.................................. 24

23.......... Regulations may provide for matters relating to committee............... 24

Division 3—Independent advisory council                                                       26

Subdivision A—Establishment, functions and status                                        26

24.......... Establishment and functions of the independent advisory council..... 26

25.......... Independent advisory committee has privileges and immunities of the Crown         26

Subdivision B—Membership                                                                                  26

26.......... Membership of the independent advisory council............................. 26

27.......... Appointment of members.................................................................. 26

28.......... Acting appointments......................................................................... 27

Subdivision C—Members’ terms and conditions                                              28

29.......... Remuneration.................................................................................... 28

30.......... Leave................................................................................................. 29

31.......... Disclosure of interests to the Minister............................................... 30

32.......... Disclosure of interests to the independent advisory council.............. 30

33.......... Resignation....................................................................................... 30

34.......... Termination of appointment.............................................................. 31

35.......... Other terms and conditions............................................................... 31

Subdivision D—Procedures of the independent advisory council                32

36.......... Who presides at meetings.................................................................. 32

37.......... Regulations may provide for other procedural matters...................... 32

Division 4—Functions of Chief Executive Medicare                                  33

38.......... Registered repository operator.......................................................... 33

Part 3—Registration                                                                                                            34

Division 1—Registering consumers                                                                     34

39.......... Consumers may apply for registration.............................................. 34

40.......... When a consumer is eligible for registration..................................... 34

41.......... Registration of a consumer by the System Operator......................... 34

Division 2—Registering healthcare provider organisations                  36

42.......... Healthcare provider organisation may apply for registration............. 36

43.......... When a healthcare provider organisation is eligible for registration.. 36

44.......... Registration of a healthcare provider organisation............................. 36

45.......... Condition of registration—uploading of records, etc........................ 37

46.......... Condition of registration—non-discrimination in providing healthcare to a consumer who does not have a PCEHR etc........................................................................................................... 38

Division 3—Registering repository operators, portal operators and contracted service providers      39

47.......... Persons may apply for registration as a repository operator, a portal operator or a contracted service provider       39

48.......... When a person is eligible for registration as a repository operator, a portal operator or a contracted service provider.......................................................................................................... 39

49.......... Registration of a repository operator, a portal operator or a contracted service provider          40

50.......... Condition about provision of information to System Operator......... 40

Division 4—Cancellation, suspension and variation of registration 41

51.......... Cancellation or suspension of registration......................................... 41

52.......... Variation of registration.................................................................... 43

53.......... Notice of cancellation, suspension or variation of registration etc..... 43

54.......... Effect of suspension.......................................................................... 44

55.......... PCEHR Rules may specify requirements after registration is cancelled or suspended             45

Division 5—The Register                                                                                           46

56.......... The Register...................................................................................... 46

57.......... Entries to be made in Register........................................................... 46

Division 6—Information use and disclosure for identity verification 47

58.......... Identifying information may be used and disclosed.......................... 47

Part 4—Collection, use and disclosure of health information included in a registered consumer’s PCEHR                                                                                                                                       49

Division 1—Unauthorised collection, use and disclosure of health information included in a consumer’s PCEHR                                                                                                     49

59.......... Unauthorised collection, use and disclosure of health information included in a consumer’s PCEHR     49

60.......... Secondary disclosure........................................................................ 49

Division 2—Authorised collection, use and disclosure                               51

Subdivision A—Collection, use and disclosure in accordance with access controls       51

61.......... Collection, use and disclosure for providing healthcare.................... 51

62.......... Collection, use and disclosure to nominated representative............... 51

Subdivision B—Collection, use and disclosure other than in accordance with access controls   52

63.......... Collection, use and disclosure for management of PCEHR system.. 52

64.......... Collection, use and disclosure in the case of a serious threat............. 52

65.......... Collection, use and disclosure authorised by law.............................. 53

66.......... Collection, use and disclosure with consumer’s consent................... 53

67.......... Collection, use and disclosure by a consumer................................... 53

68.......... Collection, use and disclosure for indemnity cover........................... 53

69.......... Disclosure to courts and tribunals..................................................... 54

70.......... Disclosure for law enforcement purposes, etc................................... 55

Division 3—Prohibitions and authorisations limited to PCEHR system                56

71.......... Prohibitions and authorisation limited to health information collected by using the PCEHR system        56

Division 4—Interaction with the Privacy Act 1988                                    58

72.......... Interaction with the Privacy Act 1988 ................................................ 58

73.......... Contravention of this Act is an interference with privacy.................. 58

73A....... Information Commissioner may disclose details of investigations to System Operator            59

73B....... Obligations of System Operator in relation to correction, etc............ 59

Part 5—Other civil penalty provisions                                                                     60

74.......... Registered healthcare provider organisations must ensure certain information is given to System Operator            60

75.......... Certain participants in the PCEHR system must notify data breaches etc.                60

76.......... Requirement to notify if cease to be eligible to be registered............. 62

77.......... Requirement not to hold or take records outside Australia................ 62

78.......... Participant in the PCEHR system must not contravene PCEHR Rules 63

Part 6—Civil penalty supporting provisions                                                        64

Division 1—Civil penalty orders                                                                           64

79.......... Civil penalty orders........................................................................... 64

80.......... Civil enforcement of penalty............................................................. 65

81.......... Conduct contravening more than one civil penalty provision............ 65

82.......... Multiple contraventions..................................................................... 65

83.......... Proceedings may be heard together................................................... 66

84.......... Civil evidence and procedure rules for civil penalty orders............... 66

85.......... Contravening a civil penalty provision is not an offence................... 66

Division 2—Relationship to other proceedings                                              67

86.......... Civil proceedings after criminal proceedings..................................... 67

87.......... Criminal proceedings during civil proceedings................................. 67

88.......... Criminal proceedings after civil proceedings..................................... 67

89.......... Evidence given in civil proceedings not admissible in criminal proceedings            67

Division 3—Other matters                                                                                       69

90.......... Ancillary contravention of civil penalty provisions........................... 69

91.......... Mistake of fact.................................................................................. 69

92.......... State of mind..................................................................................... 70

93.......... Civil penalty provisions contravened by employees, agents or officers 70

Part 7—Voluntary enforceable undertakings and injunctions                 71

94.......... Acceptance of undertakings.............................................................. 71

95.......... Enforcement of undertakings............................................................ 71

96.......... Injunctions........................................................................................ 72

Part 8—Other matters                                                                                                        75

Division 1—Review of decisions                                                                            75

97.......... Review of decisions.......................................................................... 75

Division 2—Delegations                                                                                             77

98.......... Delegations by the System Operator................................................. 77

Division 3—Authorisations of entities also cover employees                 78

99.......... Authorisations extend to employees etc............................................ 78

Division 4—Treatment of certain entities                                                        79

100........ Treatment of partnerships.................................................................. 79

101........ Treatment of unincorporated associations......................................... 79

102........ Treatment of trusts with multiple trustees.......................................... 79

103........ Exception in certain circumstances.................................................... 80

104........ Division does not apply to Division 3 of Part 3................................ 80

Division 5—Alternative constitutional bases                                                  81

105........ Alternative constitutional bases......................................................... 81

Division 6—Annual reports and review of Act                                              84

106........ Annual reports by Information Commissioner.................................. 84

107........ Annual reports by System Operator.................................................. 84

108........ Review of operation of Act............................................................... 85

Division 7—PCEHR Rules, regulations and other instruments           87

109........ Minister may make PCEHR Rules.................................................... 87

110........ Minister may determine a law of a State or Territory to be a designated privacy law               89

111........ Guidelines relating to the Information Commissioner’s enforcement powers etc.    89

112........ Regulations....................................................................................... 89

 

A Bill for an Act to provide for a system of access to electronic health records, and for related purposes

The Parliament of Australia enacts: