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The existing regulating process for awarding the CE marking for algorithm based programs doesn't provide adequate protection to the general public. SYSTEMATIC EVALUATION REGISTRATION PROSPERO CRD42016033595. Published by the BMJ Publishing Group Restricted. For permission to use (where not currently provided under a licence) please visit http//group.bmj.com/group/rights-licensing/permissions.BACKGROUND Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder with unknown etiology. E