Parliament Speech 12 Nov : Second Reading of the National Registry Of Diseases Bill

12 Nov 2007

By Khaw Boon Wan

Venue: Parliament

The National Registry Of Diseases Bill

Mr Speaker, Sir, I beg to move, "That the Bill be now read a second time."

INTRODUCTION

2. Rational healthcare policies are underpinned by accurate and timely information.  For example, should we promote regular breast screening among Singaporean women?  If so, for which age groups and at what frequency?  Settling such policies require robust analysis of cost-effectiveness and survival data, without which our decisions will be merely arbitrary or based on data drawn from other countries which may or may not apply to Singaporeans.  Good information is especially critical when we have to deal with diseases such as cancer, heart disease, stroke and kidney failures that are major causes of death and morbidity among Singaporeans.

3. There are many ways to collect such information.  We do so through periodic surveys but such data can only provide a snapshot of the prevailing situation at a particular point in time.  We need to supplement this with continuous time-series data which tracks the incidence and outcomes of the disease in the population.  A well established method for gathering such information is through setting up a national disease registry.

4 With time-series data collected by the registry we can answer many critical health policy questions, such as:

i. What is the number of new cases of a disease every year - is it increasing or decreasing – do we need to adjust the type of health services to meet this changing trend?  

ii. Is the disease affecting a particular segment of the population more than others - how can we better target our prevention and treatment programmes?

iii. How do people suffering from the chronic disease fare? How long do they survive and how do we compare with other countries?

iv. Have prevention and treatment programmes made a difference?

Disease Registries

5. In 1968, we set up our first disease registry, which was the Singapore Cancer Registry.  This was followed by the Heart Registry in 1988 and the Renal Registry in 1993.  Currently, the Stroke Registry is being piloted in some public hospitals.  These four registries make up our National Registry of Diseases.

6. A good national registry must meet two criteria.  First, it must be comprehensive i.e.  it should cover all cases in the country.  If a Registry misses out a significant segment of the population, this may result in under or over reporting of disease burden.  For instance, it would be wrong to conclude from reports drawn from one hospital that cases of a particular disease have increased nationally. 

7. Second, the registry must be well-maintained with close tracking of how the disease progresses over time.  This requires the submission of individualised information, so that new data can be matched with existing data in the registry, thus avoiding any double-counting.

8. Our current disease registries suffer a major limitation as it is based on voluntary reporting.  While public hospitals have been forthcoming in reporting, many private hospitals have largely not taken part.  As a result, our registries are incomplete.  A major concern of the healthcare providers is the lack of clarity on the legal basis for the disclosure of individualised information to disease registries, whether they will be breaching medical confidentiality.

LEGISLATION

9. Formal attempts at registering diseases date back to 1728 – the year of London’s first General Census of Cancer.  This was followed by attempts in the Netherlands, Spain, Portugal, Sweden, Hungary etc.  Most of these attempts failed due to incompleteness of data, as the reporting was voluntary.  The breakthrough came from the United States where a regulation was enacted in 1939, requiring reporting of all cancer cases diagnosed in New York State.  Since then, the US has made cancer reporting mandatory in most states.  Similar laws have been passed over the last 50 years in Canada, Australia, New Zealand, Denmark, Norway, Finland and Germany, to name a few.  We have studied legislation from some of these countries and drawn on relevant features when drafting our Bill.

10. The National Registry of Diseases Bill makes it mandatory for healthcare institutions to submit relevant epidemiological data to the National Registry of Diseases for public policy and planning purposes.  The Bill also commits MOH to responsible stewardship in the storage and disclosure of registry data – by ensuring that patient confidentiality is observed by all persons who maintain and use the data.  The Registry is already subject to stringent governance standards in securing the information collected and protecting patient confidentiality.  The Bill articulates these practices and provides for powers of enforcement.

Objectives

11. The Bill aims to achieve four objectives:

One: Comprehensive Coverage

12. The Bill makes it mandatory for the manager of a healthcare institution to notify the Registry when a person is diagnosed with or undergoes treatment for a reportable disease listed in the Schedule to the Bill.  The types of cases that have to be reported will be further specified in subsidiary legislation.  The Bill also empowers the Registry to collect information about notified cases from the relevant medical records.  The kind of information that may be obtained will be set out clearly in subsidiary legislation.  Patient consent is not required.

13. Cancer will be the first reportable disease listed in the Schedule as the current cancer registry is well established with clearly defined work processes.  MOH will add further diseases to the Schedule only if the collection of such information is essential to support national policies.  Communicable diseases will not be covered under this Bill, as there are already provisions under the Infectious Diseases Act to obtain information on these diseases for the purpose of disease prevention and control.

Two:  Basic Data Requirements

14. Collection of detailed information for every case of a disease is a tedious and expensive exercise.  We will therefore only collect data that is essential for public health planning.  This will vary for different reportable diseases and the type of information collected will be set out clearly in subsidiary legislation.  Any change to the list of information that can be collected will require Ministerial approval and will be published in the Government Gazette.

15. While it may be tempting to try and collect as much information as possible to anticipate future policy needs, this is neither feasible nor desirable.  Excess data reporting imposes a burden on healthcare institutions.  Neither is it efficient or cost-effective for the Ministry.  We also need to respect the privileged access that this Bill provides to patients’ medical records.  We are sensitive to the fact that healthcare policy questions may change over time, but instead of collecting a lot of information in anticipation, we will review and make some changes to the data collected by the Registry from time to time.

16. To make compliance as painless as possible, the Registry will work with healthcare institutions to facilitate convenient reporting.  This includes batch reporting by linkages with hospital information systems, online reporting through the internet, or submission of simple paper forms.  As we are dealing with chronic diseases, instantaneous real-time reporting is not required and a reasonable grace period will be provided.

Three: Patient Privacy and Data Security

17. In addition to administrative safeguards, such as clearly defined operating procedures with strict access controls to the Registry, encryption of data and regular audits, which are already in place, the Bill imposes a very strict obligation on all officers and agents of the Registry to protect confidential data.  Similarly, those persons who request for and receive Registry data are bound to observe conditions of confidentiality set by the Registrar.  Any person, including a registry officer or agent, who discloses individually-identifiable information from the Registry in breach of the Bill faces imprisonment of up to 12 months or a fine of up to $10,000, or both.

Four: Purposes of Disclosure

18. The Bill clearly lays down the rules as to whom, and for what purpose, and in what form, the information can be released.  In addition to its primary use by MOH for healthcare policy planning, we anticipate that the public, doctors, academics and researchers will want to know some key statistics about the chronic diseases.  The Registry Office will therefore publish reports of analysed data in simplified form on a regular basis.  Such reports will be made publicly-available.  The Registrar of the NRD is also empowered to release de-identified data for research of significant public health importance that has undergone rigorous scientific, ethical and regulatory scrutiny.

19. Identifiable patient information may be disclosed under the Bill for the purposes of national public health programmes.  Such disclosure will need the approval of the Director of Medical Services (DMS).  In deciding whether to give his approval, the DMS will, amongst other things, consider the aims and objectives of the programme, and whether it has any public health benefits to Singapore.  He must be satisfied that the programme cannot be carried out using anonymised data.  In addition, the DMS must also be convinced that adequate measures will be put in place to protect the individually-identifiable information from unauthorised disclosure.

20. The Bill permits identifiable patient information to be disclosed for the purposes of medical treatment or for public health research.  This will only take place if the person to whom the identifiable information relates has given the requisite consent.  NRD data will not be released for other purposes, for instance, to employers or insurance companies.

MAIN FEATURES OF BILL

21. Let me now run through the main features of the Bill.

22. Clause 2 of the Bill defines reportable diseases as those listed in the Schedule.  Cancer will be the first reportable disease.

23. Part II of the Bill establishes the National Registry of Diseases and sets out its functions.  These include the collection of information on reportable diseases, establishment of registers, compilation and publication of statistics, and the provision of information for supporting health services and national public health policies.  Clause 3 sets out the various categories of officers that may be appointed to run the Registry.

24. Clause 6, in Part III of the Bill, makes the notification of reportable diseases mandatory for managers of all healthcare institutions.  The burden is placed on the manager as he has the management and control of the institution.  Very limited data will be required to make a notification.  Clause 7 empowers registry officers or agents to follow up on the notification to extract patient data from the relevant medical records.  The kind of information that can be obtained will be predetermined, and will be listed clearly in subsidiary legislation.

25. Part IV addresses the issues of confidentiality and disclosure of Registry information.  It imposes stringent obligations on registry officials and all other persons who request for and receive registry data.  Unauthorised disclosure of identifiable personal information stored in the Registry is punishable with a jail term or a fine, or both.

26. Clause 9 allows the Registrar to release anonymised information to any person on request, and to charge a fee and set conditions that have to be met.  Clause 10 provides for the release of identifiable personal information for the conduct of national public health programmes, while Clause 12 provides for the release of identifiable data for the purposes of public health research but only if the requisite patient consent has been obtained.  Clause 11 allows patients to authorise their doctors to retrieve their registry data if this is absolutely necessary for their proper treatment.

27. Clause 13 in Part V of the Bill provides for the appointment of investigation officers.  Clauses 14 and 15 clothe these officers with enforcement powers that will allow them to investigate offences committed under this Bill.

28. Part VI deals with a host of miscellaneous matters.  Clause 17(2) is noteworthy as it clarifies that a person who makes a notification to the Registry or who makes available to the Registry any document or information for the purposes of complying with the Bill will not incur liability for breach of confidence or of professional ethics.

IMPLEMENTATION PLAN

Reportable Diseases

29. To facilitate the smooth implementation of this Bill and to allow healthcare institutions to ease into this new reporting framework, only cancer will be listed as a reportable disease for now.  The other three national-level disease registries maintained by the NRD for stroke, heart and renal disease will be reviewed for possible inclusion over the next two years.  Listing of additional reportable diseases will depend on epidemiological and public health needs.

Feedback and Consultation

30. Extensive public consultations were held with doctors, healthcare administrators, ethics and regulatory bodies, and researchers.  There was general support for the Bill, and points of concerns have been addressed.

CONCLUSION

31. The National Registry of Diseases Bill, and the Registry that it will create, will play a vital role in our public health efforts.  It provides for the compilation of important information on non-communicable diseases that will guide policymaking on national healthcare and the formulation of public health programmes.  It will provide greater clarity on the type of health information which can be collected at national level and spells out the purpose for, and the form in which it may be put to use.

32. I ask all members of this House to support this Bill.

Mr.  Speaker, Sir, I beg to move.

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