Consultations

Gather feedback and answer questions from impacted stakeholders about:

1. Proposed formalization of a voluntary process for health businesses and
2. Proposed expansion and enhancement of an existing process for high-risk health technology.

Phase 1 (current):

• Seek health business feedback on the draft legislation authorizing the Council to license health service providers and regulate the importation and registration of high-risk health technology

Phase 2 (pending approval of draft legislation):

• Invite health businesses to submit applications to create a baseline register of health businesses
• Seek health business feedback on the existing process and proposed enhancements to the form and process

Phase 3 (pending completion of Phase 2):

• Draft standards of operation in collaboration with subject matter experts
• Seek health business feedback on draft standards for their type of business (based on information submitted by health businesses during Phase 2)

This legislation is part of a multi-phased approach to ensuring health services provided to the public are safe and of high quality. This will be achieved through a requirement for health service providers to be licensed and for permission to be sought to import and/or operate high risk health technology. This first phase involves the establishment of a centralized database on the type and number of businesses, services and high-risk health technology currently in Bermuda.

Previous attempts have been made to collect this information through a voluntary registration process but we have had minimal responses in 5+ years thus legislation is necessary to make it happen.

Fines and imprisonment are standard penalties for offences related to noncompliance with legislation. However, based on feedback received, imprisonment has been removed as a penalty. This removal does not dismiss the risk to the public of persons intentionally operating services or technologies that are not in compliance.

It should be noted that given the risk associated with operating a business without a license or operating high-risk health technology without appropriate permission to do so, the proposed fines (on conviction) have been increased.

The fines have been drafted based on what exists in similar legislation and based on the risk non-compliance.

Standards of Operation and Codes of Practice will be drafted in collaboration with the applicable statutory bodies and health business groups to ensure they are practical without compromising safety and quality. This will be addressed during subsequent consultation periods.

The following are applicable to businesses and equipment:

• Contractor to conduct desk audits
• On site inspector to support contractor
• Contractor to conduct on-site inspections
• The Health Council also has health professionals on staff (i.e., inclusive of Physicians, Nurses, Allied Health professionals), in addition the Health Council Board includes health professionals and health business owners.

This consultation is a continuation of those sessions, yes. In October and November, we consulted on the concept of licensing. This consultation is the next phase of that as we are now sharing the proposed draft contents of the regulations which will make the previously discussed concepts real and enforceable.

Applications will be reviewed in accordance with a documented procedure; the draft of which will be provided to the impacted stakeholders for feedback during subsequent consultation periods. The proposed regulations provide for an aggrieved applicant to request a Judicial Review through the Supreme Court to review the Health Council’s decision-making process.

Small businesses will have equal opportunity to give feedback on the development of standards and enhancement of the application process for subsequent licensing periods to ensure expectations are realistic without compromising safety and quality.

Based on feedback so far, the application process (to be used to collect baseline information) is quick and easy to use but if health businesses need assistance with that, the Health Council team is happy to help. It should be noted that more complex businesses that offer multiple types of services and use multiple types of equipment, whether large or small, will be asked to provide additional information.

Health businesses and health professionals (ie those who own or are employed by health businesses) are the primary stakeholder groups that will be impacted by the legislation if passed, thus feedback is being sought to ensure an understanding of the impact to health business and equal opportunity to share opinions about the proposed changes.

Health businesses and health professionals have been asked to review and provide feedback on:

• A slide deck with high level information regarding the proposed amendments, and
• A Googlesheet which provides additional context to the slide deck, details of the anticipated consultation phases and FAQs about the proposed regulations

Initially health service providers will be asked to complete an online application (see C2 on the HSP tab and C2 on the HRHT tab). The information submitted will be used to create a starting database of businesses and equipment.

Businesses that already have an active license or registration certificate will not be asked to complete the application(s) again during this initial phase.

Fee categories will be based on health service provider or equipment type and for health service provider fees, within each category, fees may vary based on the complexity of the business model.

For example, a practice with 1 piece of equipment and 500 patients may have a lower fee than a practice with 10 pieces of equipment and 10,000 patients.

The health service provider is the health business. Licensure, as per the proposed regulations, is based on the type of business regardless of the owner. Individuals employed by a health business to provide health services are health professionals.

The presentation is based on the draft legislation. Currently the proposed regulations are to “license health service providers” and to “register high risk health technology”.

Ideally HNAs (or other similar standardized process for considering comparative information across jurisdictions) would be used to determine need for all interventions.

However, the final decision maker is not the same across all health interventions which means the application of this ideal is not automatic. As a reminder, this legislation is only applicable to health service providers (businesses) and high-risk health technology (equipment).

Voluntary processes rely on stakeholder willingness to provide information rather than an enforceable requirement to provide it. By legislating what is currently voluntary (HSPs) or limited (HRHT), we are able to require the submission of information needed to assess safety and quality of services/care.

The following additional resources will be used to support the proposed functions:

• Contractor to conduct desk audits
• On site inspector to support contractor
• Contractor to conduct on-site inspections
• The Health Council also has health professionals on staff (i.e., inclusive of Physicians, Nurses, Allied Health Professionals), in addition the Health Council Board includes health professionals and health business owners.

Where the legislation provides for enforcement of compliance (ex. inclusion of penalties), it has been effective (ex. monitoring employer compliance with the HIA).

This will be confirmed during later phases of consultation.