DSSA Regulatory Requirements

Regulatory Change Notification Period Guidelines

The Dental Software Suppliers Association (DSSA) works closely with several regulatory bodies, including all UK NHS regional authorities, to agree and manage the implementation of mandatory, and occasionally non-mandatory, change plans.

Close alignment between the regulatory body and the DSSA members is required to ensure that dental providers (customers of the membership) both continue to meet legislative requirements and also ensure that they transition across any change boundary with minimal disruption.

Clearly, this type of change typically has a “hard go-live date” as both members and the regulatory body’s infrastructure teams often must prepare systems in advance to affect the change at a very specific instant in time.

Its therefore essential that sufficient notice of such changes is recognised, and time built into schedules to both clarify specifications, schedule development/deployment activities and provide sufficient time and resources to test implementation prior to “Go Live “.

The DSSA membership ranges from small privately-owned firms to large corporate-backed companies.  As such the range of technologies, platforms, resources and capabilities can vary significantly across the membership. The DSSA recognises that any change therefore represents a set of unique challenges for each supplier, yet as a supplier community, we must come together to ensure that all suppliers have a fair opportunity to deliver any change in a manner that does not unduly harm a members business operation whilst also meeting the regulator’s need to implement the change in a timely manner.

The DSSA, therefore, promotes the following guidelines to help regulators and members alike approach such change plans from a common set of expectations of what should be considered as reasonable notice periods for different types of change.

The length of notification period required is largely driven by certain key factors:

Size of change

Complexity of change

The novelty of change (i.e., use of new technology or use of a new operating model)

Criticality of the change and the level of pre-deployment testing required to meet the required quality expectations etc.

These factors have been considered in the basic three level change model described below.

In addition to this, it must be recognised that the DSSA is potentially dealing with change from several regulatory change agents who do not necessarily coordinate their activities to prevent spikes in demand for system change.

The DSSA therefore requests that whenever possible as much advance notice of pending change is providing (even if full details are not yet available) so that warnings can be given about overlapping change plans and allow negotiation to smooth the risk of over whelming members with too much concurrent change.

Minor Change

Requires a minimum of 4 weeks notice, ideally 8 weeks is preferred where possible.

A minor change is normally both small in scope and low in complexity.

It would normally involve the introduction of no or very little in the way of new functionality.

Most likely restricted to product configuration changes such as the implementation of a new fee schedule or minor point fixes to make functional adjustments.

Unlikely to involve use of new technologies of development of significant new capabilities

Testing requirements are likely to be minimal.

Requests for more than 2 minor change requests a year from the same regulatory body may be considered excessive.

Significant Change

Requires a minimum of 12 weeks notice, ideally 6 months is preferred where possible.

A significant change is likely to be moderate size and/or of moderate complexity.

It will normally also be restricted to largely one single focus of change activity and functional area.

It will require mature and detailed data / functional specifications and business rules supplied before commitment to development activity can be considered.

May involve small elements of new technology / new operating models etc.

Testing requirements are likely to be significant so timely access to testing frameworks and test plans are likely to be essential.

Requests for more than 1 significant change requests a year from the same regulatory body may be considered excessive.

Major Change

Requires a minimum of 6 months notice period, although in reality since the potential size and scope of change is unlimited it’s probably best to assume in most cases changes of this nature are subject to detailed review and negotiation of timelines, including consideration of options such as phased delivery models to descope delivery risk etc.

A major change is likely to be large in both size and/or complexity.

It may consist of a set of functional module changes (the boundaries of which may form the logical breakpoints for a phase delivery approach).

It will require mature and detailed data / functional specifications and business rules supplied before commitment to development activity can be considered. Experience has shown that several rounds of specification review and refinement should be allowed for in the timelines.

Extra time should be factored in if novel technology or operating practices are being introduced.

Testing requirements are likely to be significant so timely access to testing frameworks and test plans are likely to be essential. As will significant contingency to allow for multiple test and fix development cycles.

Requests for more than 1 significant change requests in any 2-year period, from the same regulatory body may be considered excessive.