DEC 2013 Pharmaceutical Society of Australia V00.0 2012 Pharmacy policy for participation in the National eHealth record system © Pharmaceutical Society of Australia Ltd., 2013 This document contains material that has been provided by the Pharmaceutical Society of Australia (PSA), and may contain material provided by the Commonwealth and third parties. Copyright in material provided by the Commonwealth or third parties belong to them. PSA owns the copyright in the policy template as a whole and all material in the template that has been developed by PSA. In relation to PSA owned material, no part may be reproduced by any process except in accordance with the provisions of the Copyright Act 1968 (Cth), or the written permission of PSA. Requests and inquiries regarding permission to use PSA material should be addressed to: Pharmaceutical Society of Australia, PO Box 42, Deakin West ACT 2600. Where you would like to use material that has been provided by the Commonwealth or third parties, contact them directly. The Pharmaceutical Society of Australia has developed a draft policy template for pharmacy organisations to adapt to their individual practice needs when registering for participation in the National eHealth record system. These policies are to be used as a guide and must be individualised to suit your organisation’s needs. Do not implement these policies without first considering the specific needs of your organisation. Read this policy document in conjunction with the Pharmaceutical Society of Australia National eHealth record system guidelines for pharmacy. The policy template has been developed with current knowledge as of 20 August 2013. Regular review of this policy may be required if new information is released. Disclaimer Neither the PSA, nor any person associated with the preparation of this document, accepts liability for any loss which a user of this document may suffer as a result of reliance on the document and, in particular, for: use of the policy template for a purpose for which it was not intended any errors or omissions in the policy template any inaccuracy in the information or data on which the policy template is based or which is contained in them any interpretations or opinions stated in, or which may be inferred from, the policy template. Notification of any inaccuracy or ambiguity found in this document should be made without delay in order that the issue may be investigated and appropriate action taken. Please forward your notification to: Policy and Practice Group Pharmaceutical Society of Australia PO Box 42 Deakin West, ACT 2600 Pharmacy policy for participation in the National eHealth record system DEC I © Pharmaceutical Society of Australia Ltd. I 2 Pharmacy policy for participation in the National eHealth record system The National eHealth record system was previously known as the Personally Controlled Electronic Health Record system (PCEHR) Purpose This policy is designed to ensure that this pharmacy organisation, ________________________, has registered and obtained appropriate authorisation to participate electronically in the National eHealth record system and is utilising conformant pharmacy software for access. This pharmacy organisation is committed to addressing specific matters for our participation in the National eHealth record system (in accordance with the legislative requirements for the PCEHR system). This pharmacy organisation will seek to communicate and enforce this policy to all its employees as well as any organisations with whom it engages under contract. Policy manager Name: (person nominated to implement and maintain the policy e.g. pharmacy manager) Tel: Fax: Email: Approval authority Name: (person with authority to sign off on content and updates e.g pharmacy owner) Tel: Fax: Email: Review This policy will be reviewed when material is updated, changed, or risks are identified and at least annually as indicated in the log below. This will include identification of new risks and consideration of anything that may result in unauthorised access, misuse or unauthorised disclosure of information or accidental disclosure of information, and of any changes to the National eHealth record system or relevant PCEHR legislative framework since the last review. Review log Review period Monthly/quarterly/six monthly/yearly Next review due date Review reference number Approved/amended/ rescinded Date Approved by Pharmacy policy for participation in the National eHealth record system DEC I © Pharmaceutical Society of Australia Ltd. I 3 Terminology Term Definition Authorised healthcare provider A healthcare provider who has been authorised by a registered healthcare provider organisation to access the National eHealth record system on their behalf Authorised representative A person authorised under a law of the Commonwealth, a state or a territory, or a decision of an Australian court or tribunal, or otherwise deemed an appropriate person by the System Operator, to act on behalf of an individual Conformant software Software that can interact with the National eHealth record system allowing the viewing, adding and retrieving of documents Default access control Consent given by the consumer, at the point of registering with the National eHealth record system, for their information to be uploaded to their eHealth record by healthcare providers involved in their health care eHealth record A sharable record of a consumer’s health information maintained by the System Operator Episode of care A consultation or clinical event involving the care of a consumer Event summary A clinical document that may be uploaded to a consumer’s eHealth record summarising one or more healthcare events Healthcare Provider Identifier for Individuals (HPI-I) A unique 16 digit number used to identify individual healthcare providers who deliver health care in the Australian healthcare setting e.g. pharmacist, general practitioner Healthcare Provider Identifier for Organisations (HPI-O) A unique 16 digit number used to identify organisations which deliver health care in the Australian healthcare setting. e.g. community pharmacies, pharmacy service organisations Health Identifier (HI) Service Provides unique identifiers for consumers, individual healthcare providers and organisations. These identifiers are used in electronic health communications to ensure information is matched to the right consumer and shared between the right healthcare providers Healthcare provider organisation An entity, or a part of an entity, that has conducted, conducts, or will conduct, an enterprise that provides health care (including health care provided free of charge) e.g. a community pharmacy, pharmacy service organisations Individual Healthcare Identifier (IHI) A unique 16 digit number used to identify individuals who receive or may receive health care in the Australian health system Nominated healthcare provider A healthcare provider who has been nominated by the consumer to prepare, create, upload and manage the shared health summary in the consumer’s eHealth record. It must currently be a general practitioner, registered nurse or Aboriginal and Torres Strait Islander health practitioner Nominated representative A representative nominated by the eHealth record holder or their authorised representative to access their eHealth record. A nominated representative can view their health information and but may not add to or edit an eHealth record e.g. family member/carer Organisation Maintenance Officer (OMO) A person or persons registered under the HI Service with authority to act on behalf of a healthcare provider organisation in its interaction with the System Operator of the eHealth record system. The OMO’s primary role is to undertake the day-to-day administrative tasks in relation to the HI Service and the eHealth record system Personal health summary A document created by the consumer that includes medicines, allergies and adverse reactions. This section of the eHealth record is accessible to healthcare providers Pharmacist For the purpose of these Guidelines, pharmacist will include all registered pharmacists working in community pharmacy and all pharmacists working in primary care Pharmacy For the purpose of these Guidelines, pharmacy will include community pharmacies and consultant pharmacists with an ABN Provider portal The website through which healthcare provider organisations can access the eHealth record system and view an individual’s eHealth record without having to use conformant software. The provider portal is a view and download only service Responsible Officer (RO) A person registered under the HI Service and has authority to act on behalf of healthcare provider organisations in its interaction with the System Operator e.g. owner/managing partner Shared health summary A clinical document summarising a consumer’s health status and includes information such as allergies/adverse reactions, medicines, medical history and immunisations. There is only a single shared health summary in existence at any one time. Only a nominated healthcare provider can create or update the shared health summary System Operator The person with responsibility for establishing and operating the eHealth record system. The System Operator is currently the Secretary of the Department of Health Adapted from the Department of Health and Ageing Personally controlled electronic health record system glossary of terms. Feb 2013 Pharmacy policy for participation in the National eHealth record system DEC I © Pharmaceutical Society of Australia Ltd. I 4 Background and rationale Pharmacy organisations need to have met all the legal requirements to participate in the National eHealth record system and installed conformant pharmacy software to ensure that dispensing records and clinical documents such as referrals and event summaries can be uploaded to consumers’ National eHealth record, when applicable. Legal requirements Evidence of the submission of the completed National eHealth record system Participation Agreement and the HPI-O registration is retained: ________________________________ (List location of Participation Agreement and HPI-O here) Software requirements The conformant pharmacy software used in this organisation is: _______________________ (List pharmacy software here) Team member responsibility It is the responsibility of all pharmacists and pharmacy staff in our organisation to understand the legal and compliance responsibilities related to our participation in the National eHealth record system. It is the responsibility of all pharmacy staff, who are authorised staff members for National eHealth record system purposes, to provide support for the use of the system by undertaking any administrative tasks involved in the maintenance or use of the pharmacy software. If problems arise, the appropriate software vendor and/or the company providing IT support for the organisation will be contacted to assist in resolving the problem in a timely manner. List the name of the staff member and their responsibility in the table below. Responsibility Name Responsible officer (RO) Organisation maintenance officer (OMO) Authorised contact person National eHealth record system administration officer National eHealth record system training officer National eHealth record system IT officer Pharmacy policy for participation in the National eHealth record system DEC I © Pharmaceutical Society of Australia Ltd. I 5 Policy and procedures PHARMACY ORGANISATION PROCEDURE Yes/no Completed and submitted the National eHealth record system Participation Agreement Completed and submitted the application to register as a healthcare provider organisation and to obtain a Healthcare Provider Identifier – Organisation (HPI-O) Completed and submitted the application to request a National Authentication Service for Health Public Key Infrastructure (NASH PKI) Certificate for healthcare organisations to gain access to the conformant clinical software Completed the application to establish a list of authorised provider individuals for access to National eHealth record system via the provider portal, if applicable Retained evidence of the submitted Participation Agreement and application to register as a healthcare provider organisation Uses compliant pharmacy software for accessing the National eHealth record system to post dispensed medicines and create and post clinical documents Installed and configured compliant pharmacy software according to vendor’s implementation guidelines for accessing the National eHealth record system Provides practice-based education and skills-based training to all our pharmacists and staff to ensure compliance with the policy and competency in the use of the technology Pharmacy policy for participation in the National eHealth record system DEC I © Pharmaceutical Society of Australia Ltd. I 6 PHARMACY ORGANISATION POLICY Note: The pharmacy organisation can amend this policy based in their individual circumstances. However, any omission from this policy will need to be justified if queried. 1. This organisation will communicate this policy, and ensure that this policy remains readily accessible, to all its employees and to any healthcare providers to whom this organisation supplies services under contract. [PCEHR Rules 2012 No. 25 (2)] Action Responsibility This policy will: RO or OMO be communicated to all staff (including contractors e.g. locums) on a regular basis as well as when updated (circle nominated officer) will be communicated in full (or sections within) within 7 days of receiving such a request from the System Operator as received in writing be readily accessible to all existing members of our staff to whom we give authorisation to access the National eHealth record system on our behalf be made available to any organisation with whom we engage under contract (where applicable) e.g. locums and IT service providers 2. This organisation will enforce this policy in relation to all its employees and any organisation with whom we engage under contract. [PCEHR Rules 2012 No.25(3)] This includes: (a) the manner of authorising persons accessing the National eHealth record system via or on behalf of our organisation. [PCEHR Rules 2012 No.25(4a)] Action Responsibility Our organisation will authorise the staff members within our team that require access to the National eHealth record system by: generating and maintaining an authorised employee register, which includes the name and HPI-I for all pharmacists working in our organisation that we authorise to access the National eHealth record system on our behalf registering both our HPI-O and the HPI-Is of those pharmacists, who have opted into the National eHealth record system, for publication in the Healthcare Provider Directory (HPD) recording and keeping current the credentials of all pharmacists who require access to the National eHealth record system ensuring pharmacists who are authorised to access the system are logged in under their user identity (i.e. initials in the system) prior to accessing a National eHealth record (refer to Appendix A). This is required for the PCEHR system audit log requirements determining access restrictions for individuals in the organisation with HPI-Is e.g. only pharmacists with a HPI-I stored and validated in this organisation’s dispensing software will access the National eHealth record system OMO OMO OMO RO or OMO (circle nominated officer) (b) the manner of suspending and deactivating the user account of any authorised person who leaves our organisation. [PCEHR Rules 2012 No.25(4a)(i)] (c) the manner of suspending and deactivating the user account of any authorised person whose duties no longer require them to access the National eHealth record system. [PCEHR Rules 2012. No.25 (4a)(iii)] Action Responsibility For a staff member who leaves our organisation we will deactivate their account by: OMO de-activating the HPI-I in our dispense software and removal of individual login details changing the password on the dispensing personal computer, as outlined in Appendix A revising our Authorised Employee Register keeping a local record of the revised Authorised Employee Register for audit trail purposes Pharmacy policy for participation in the National eHealth record system DEC I © Pharmaceutical Society of Australia Ltd. I 7 (d) the manner of suspending and deactivating the user account of any authorised person:- whose security has been compromise. [PCEHR Rules 2012. No.25(4a)(ii)] Action Responsibility For a staff member whose security has been compromised we will immediately deactivate their account by: OMO de-activating the HPI-I in our dispense software and removal of individual login details changing the password on the dispensing personal computer, as outlined in Appendix A revising our Authorised Employee Register keeping a local record of the revised Authorised Employee Register for audit trail purposes keeping record of the details surrounding the event (e.g. who and why) pursuing the necessary disciplinary action (e) the training that will be provided before a person is authorised to access the National eHealth record system, including in relation to how to use the National eHealth record system accurately and responsibly, the legal obligations on our organisation and our staff members using the National eHealth record system and the consequences of breaching those obligations. [PCEHR Rules 2012 No.25(4b)] Action Responsibility As part of the staff induction process and for all existing staff to whom we give authorisation to access the National eHealth record system on our behalf, we will provide full National eHealth record system training. The training will include how to use the National eHealth record system accurately and responsibly. Training will also be conducted as new functionality is introduced into the system. We will utilise the training resources made available by the System Operator as a minimum. RO or OMO To assist in ensuring training completion and for audit purposes, a record will be kept confirming the training completed by each authorised staff member and the date completed. Training will be completed before a member of the organisation is authorised to access the National eHealth record system. RO or OMO The legal obligations on our organisation and our authorised staff members using the PCEHR system and the consequences of breaching these obligations can be viewed in full in the PCEHR Rules 2012 At: www.comlaw.gov.au/Details/C2012A00063 RO (circle nominated officer) (circle nominated officer) This policy specifically relates to Rule 25 of the PCEHR Rules 2012. We also acknowledge the PCEHR Act 2012 and Terms of Participation, which also outlines the legal obligations of this organisation when using the system. Notwithstanding any action the System Operator may take with regard to breaches of the PCEHR Act 2012, the organisation will continue to implement local staff conduct and disciplinary policies with regard to any staff unauthorised access to the National eHealth record system. RO e) the process for identifying a person who requests access to a consumer’s National eHealth record and communicating the person’s identity to the System Operator so that the healthcare provider organisation is able to meet its obligations under section 74 of the PCEHR Act 2012. [PCEHR Rules 2012 No.25(4c)] Identification of a staff member who is authorised to access the National eHealth record system will be confirmed in the following ways: collecting and recording (in both our dispense software and our internal records) the Healthcare Provider Identifier – Individual (HPI-I) for all pharmacists working in our organisation allocating and recording internal staff member identification codes recording in our dispensing software a unique individual identifier each time a record is accessed (including write, read and download of documents) keeping a local record of the revised authorised staff member’s start and finish work times. Keeping payroll/timesheets for the required timeframe (7 years) will fulfil this requirement OMO Pharmacy policy for participation in the National eHealth record system DEC I © Pharmaceutical Society of Australia Ltd. I 8 f) the physical and information security measures that are to be established and adhered to by the healthcare provider organisation and people accessing the National eHealth record system via or on behalf of the healthcare provider organisation, including the user account management measures that must be implemented under rule 27. [PCEHR Rules 2012 No.25(4d)] Action Responsibility Staff members that this organisation authorises to access the National eHealth record system will be allocated a login for access to the dispense software. This will be managed within our IT management processes, as outlined in Appendix A, with the aim of: RO or OMO ensuring the staff members that are authorised to access the system can be identified by either a unique local identifier or system log-in ensuring our organisation has current and adequate IT system anti-viral software ensuring our disaster recovery policies and procedures are current and executable ensuring our IT systems and hardware are physically protected against unauthorised access or hacking ensuring that each authorised user of the system has a secure password (circle nominated officer) This will be complied with by implementing the requirements in Appendix A. g) mitigation strategies to ensure National eHealth record system related security risks can be promptly identified, acted upon and reported to the healthcare provider organisation’s management. [PCEHR Rules 2012 No.25(4e)] Action Responsibility This organisation will regularly review our security and procedures for accessing the National eHealth record system, report the findings to management and revise our procedures accordingly RO or OMO This organisation will set out a risk reporting procedure to allow staff to inform management regarding any suspected security issue or breach of the system In addition, this organisation may employ other mitigation strategies where relevant including: suspending or deactivating a user account changing a user password and/or login information where relevant report a security breach to the System Operator (circle nominated officer) Pharmacy policy for participation in the National eHealth record system DEC I © Pharmaceutical Society of Australia Ltd. I 9 APPENDIX A Pharmacy IT management and access to the National eHealth record system: pre-access checklist Action Yes/No Ensure this policy is communicated to all staff members including those accessing the National eHealth record system (pharmacists with a HPI-I which is validated and stored in the organisation’s computer software program) and those not accessing the system (e.g. pharmacy assistants) Provide appropriately complex passwords to all staff requiring access to the National eHealth record system and ensure all staff are aware of their responsibility to keep passwords secure Ensure National eHealth record system users change their passwords on a regular basis (e.g. monthly) Ensure the passwords are changed after the departure of staff members as part of the organisation’s departure process Ensure the computer is set to change to the screen saver automatically (when in password protection mode) after each computer is left idle for a short period of time (no longer than 5 minutes) Ensure that prior to accessing a consumer’s National eHealth record, the pharmacist accessing the National eHealth record system is the recorded user in the dispensing software Ensure that any computers with remote access (if used to access the National eHealth record system) include adequate security controls enabling the identification of the user Position all computer monitors so that data displayed on the monitor cannot be seen by members of the public Ensure that no unauthorised software is installed on the organisation’s system Ensure that adequate and current antivirus software is both installed and maintained on the organisation’s system Ensure that current and working system backups are in place and run regularly Resources Pharmacy Registration Workbook www.nehta.gov.au/our-work/implementation-and-adoption/ehealth-registrationsupport/pharmacy-registration-workbook Department of Health eHealth resources www.ehealth.gov.au/internet/ehealth/publishing.nsf/http://www.ehealth.gov.au/internet/ehealth/publishing.nsf/Content/re sources-hcpContent/resources-hcp PSA National eHealth record system guidelines for pharmacy Healthcare Identifiers Act 2010 www.comlaw.gov.au/Details/C2010C00440 The Personally Controlled Electronic Health Record Act 2012 www.comlaw.gov.au Personally Controlled Electronic Health Record Rules 2012 http://www.comlaw.gov.au/Details/F2012L01703 National Authentication Service for Health Public Key Infrastructure www.medicareaustralia.gov.au/provider/vendors/pki/index.jsp Pharmacy policy for participation in the National eHealth record system DEC I © Pharmaceutical Society of Australia Ltd. I 10 PHARMACEUTICAL SOCIETY OF AUSTRALIA LTD. ABN 49 008 532 072 NATIONAL OFFICE Pharmacy House 44 Thesiger Court Deakin ACT 2600 PO Box 42 Deakin West ACT 2600 P: 02 6283 4777 F: 02 6285 2869 E: psa.nat@psa.org.au BRANCH CONTACT DETAILS P: 1300 369 772 F: 1300 369 771 AUSTRALIAN CAPITAL TERRITORY Pharmacy House 44 Thesiger Court Deakin ACT 2600 PO Box 42 Deakin West ACT 2600 E: act.branch@psa.org.au NEW SOUTH WALES 82 Christie Street St Leonards NSW 2065 PO Box 162 St Leonards NSW 1590 E: nsw.branch@psa.org.au QUEENSLAND PACE Level 3, West Wing 20 Cornwall Street Dutton Park QLD 4102 PO Box 6120 Buranda QLD 4102 E: qld.branch@psa.org.au SOUTH AUSTRALIA Suite 7/102 Greenhill Road Unley SA 5061 E: sa.branch@psa.org.au TASMANIA 161 Campbell Street Hobart TAS 7000 E: tas.branch@psa.org.au VICTORIA Level 1, 381 Royal Parade Parkville VIC 3052 E: vic.branch@psa.org.au