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Analysis Of Regulations For Approval Of Digital Therapeutics – Healthcare


China’s digital therapeutics (DTx) business has vaulted into
the limelight as a major new investment target of the healthcare
sector, with a number of domestic companies joining the global
Digital Therapeutics Alliance (DTA).

Digital therapeutics are changing the healthcare delivery system
with evidence-based technologies that improve patient outcomes
– and how companies position and successfully commercialise
their products after regulatory approval has become one of the key
issues to their development. This article summarises the
major existing domestic regulatory policies and introduces digital
therapeutics by analysing its definition, classification and
registration approval procedure.

WHAT IS DIGITAL THERAPEUTICS?

As defined on the DTA’s official website, digital
therapeutics is driven by high-quality software programs that
provide patients with evidence-based therapeutic interventions to
prevent, manage and treat diseases. Digital therapeutics can be
used alone or in combination with medication, or in conjunction
with other therapies to improve patient care and health status.

By function, digital therapeutics can be divided into three
categories – prevention, management and treatment. Among
domestic companies with the label “digital healthcare”,
respectively falling under the categories of prevention, management
and treatment, 66Nao provides online electronic brain health cloud
services; ClouDr provides monitoring and management services for
diabetic patients; and the Recovery Plus app assists clinicians in
cardiopulmonary rehabilitation training for patients.

REGULATORY POLICY

At present, domestic regulatory policy for digital therapeutics
is still in its infancy, and there are no clear regulatory rules.
Considering that digital healthcare products are mostly in the form
of standalone software, or software containing a medical device, in
practice it is immediately necessary to confirm whether they are
categorised as medical devices.

If such a product is defined as a medical device – based
on intended use of the product combined with its processing
objects, core functions and other factors – the more
applicable concepts under the current guidelines are “mobile
medical devices” and “artificial intelligence (AI)
medical software”.

Specifically, mobile medical devices refer to devices and/or
software that use non-invasive mobile computing terminals to
achieve one or more medical purposes. AI medical software refers to
standalone software based on medical device data and AI technology
to achieve its medical purposes, with core functions including
medical device data processing, measurement, model calculation and
analysis.

According to the Classification Catalogue for Medical Devices,
classification of digital therapeutics products includes treatment
planning software, image processing software, data processing
software, decision support software, in vitro diagnosis software,
and other products such as rehabilitation training software. The
risk level can be comprehensively determined based on product
description and intended use, and the regulatory provisions on
class II/III medical devices apply. If such a product is not a
medical device, the regulatory requirements are relatively simple.
It is not required to comply with the relevant regulations on
medical devices for R&D, testing, clinical trials, registration
and production.

EVALUATION AND APPROVAL

In the example of the Recovery Plus app (among the first batch
of digital therapeutics products approved by China’s authority
of drug supervision), by assisting clinicians in guiding patients
in cardiopulmonary rehabilitation training, it is categorised under
above-mentioned rehabilitation training software, and is thus
subject to regulatory provisions on class II medical devices.

CLINICAL EVALUATION

For registration of class II/III medical devices, clinical
evaluation is required in advance – unless the product is
covered by the Catalogue of Medical Devices Exempted from Clinical
Evaluation, which came into effect on 1 October 2021.

After a preliminary search, the rehabilitation training software
to which the Recovery Plus app belongs was not included, which
means this type of medical device should still be evaluated
clinically. In addition, whether a product is required to go
through clinical evaluation may be affected by its type of
algorithm and application scenario, as well as the communication
with competent authorities.

SIMILAR REGISTRATION

The registration process of digital therapeutics products is
similar to that of ordinary medical devices; from sample testing,
clinical evaluation, submission of application, technical review,
administrative examination and approval to eventually obtaining a
Registration Certificate for Medical Device.

In particular, digital therapeutics products should follow
technical review guidelines for medical device software in the
registration process. These mainly include: Guidelines for
Technical Review of Medical Device Software Registration, the
general guidelines for medical device software proposing
requirements for software updates and versions; Guidelines for
Technical Review of Mobile Medical Device Registration, focusing on
risks arising from adoption of mobile computing technology in
medical devices and control measures; Guidelines for Technical
Review of Medical Device Cybersecurity Registration, setting out
technical review requirements for medical device cybersecurity; Key
Points for Reviewing Medical Device Software for In-depth
Learning-Assisted Decision-making, applicable to registration
application of medical device software for in-depth
learning-assisted decision-making; and Guidelines for the
Classification and Definition of Artificial Intelligence Medical
Software Products, affirming that attribution to class II/III
medical device regulation should be determined according to the
maturity level of the algorithm in medical application, and whether
it aids decision-making.

The following points should also be noted for digital
therapeutics products:

In terms of research data, if the software uses mobile
terminals, its cybersecurity capacity, display limitation, ambient
light influence and battery capacity should be studied.

Digital therapeutics products may be used in combination with
other medical devices, drugs and non-medical devices to achieve the
same intended purpose, while research data proving the safety and
effectiveness of such combined use should be provided.

As digital therapeutics products are evidence-based,
non-clinical data such as evidence-based medical literature related
to the product is also required to be submitted.

With big data and algorithm support, the digital therapeutics
industry is moving full speed ahead. The authors believe regulators
will soon make comprehensive improvements to their digital
therapeutics oversight, and provide guidance to the flourishing
business, in order to safeguard the lives and health of more
patients.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.



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