Select committee recommends SaMD – SiMD distinction in Therapeutic Products Bill

NEWS - eHealthNews.nz editor Rebecca McBeth

Parliament’s Health Committee has recommended an amendment to the Therapeutic Products Bill to distinguish between software as a medical device (SaMD) and software in a medical device (SiMD).

The Bill creates a new regulatory regime for SaMD with software covered by the scheme becoming subject to a new regulator and market authorisation regime. This means they would need authorisation before their product can be imported, supplied in, or exported from New Zealand, as well as a robust surveillance and response system for their products.

eHealthNews reported that digital health suppliers were concerned that the new Bill will capture a broad a range of unintended health technologies, stifling investment and innovation in the sector.

The select committee report recommends clarifying that SiMD is not intended to be captured under these provisions.

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It provides an example of SaMD as computer-aided detection software that performs image processing to help detect breast cancer, whereas SiMD “poses no more risk of harm to patients that any other applications that are used to facilitate remote interactions”.

“SiMD does not treat, prevent, or alleviate medical conditions, injuries, and diseases; nor does it sustain life, or investigate physiological processes. Instead, it facilitates communications between a patient and doctor,” the report says.

The committee understands that secondary legislation will be developed to specify detailed regulations and rules for SaMD and these would be based on international best practice for regulating the different phases of software development.

It also recommends the inclusion of a rule-making power to enable the Regulator to determine criteria and thresholds for when a therapeutic product would be regulated as SaMD.

A Ministry of Health departmental report on the Bill says, “medical software is a rapidly evolving area and embedding a flexible and comprehensive regulatory regime for cutting-edging medical technologies for New Zealand has been the key focus of the development of this Bill.

“The Bill does not intend to regulate software only with mechanical functions (eg, used to drive or control motors and pumps of an infusion pump to pump medication out) as a standalone medical device or used for administrative purposes (eg, data transmission from hardware devices or workflow management),” it says.

Also, software that facilitates the provision of patient care for non-therapeutic purposes, including those for productivity, communication, finance, and education, would not be considered SaMD.

Aisling Weir, special counsel, Buddle Findlay, says while the Select Committee did not alter the definition of SaMD, the recommended amendments should “go some way to alleviate industry’s fears”.

“The effect of the Bill on innovation will depend greatly on the rules and regulations that will ultimately sit under the Bill and give it practical application,” she says.

“My hope would be that these clearly state what software is excluded from the ambit of SaMD, and that those rules and regulations are informed by clear delineations around risk.”

Weir says that if the Bill is passed, the new Regulator should produce user-friendly, practical guidance to help developers and software companies to navigate the new laws.

Ryl Jensen, chief executive of the Digital Health Association, says she is thrilled with the recommendations, which are in line with the industry body’s submission.

“This sets us on a firm path to achieving our goals around having sensible laws guiding SaMD,” she says.

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