OBJECTIVE: Artificial intelligence (AI) holds remarkable potential to improve care delivery in dermatology. End users (health professionals and general public) of AI-based Software as Medical Devices (SaMD) require relevant labelling information to ensure that these devices can be used appropriately. Currently, there are no clear minimum labelling requirements for dermatology AI-based SaMDs.
METHODS: Common labelling recommendations for AI-based SaMD identified in a recent literature review were evaluated by an Australian expert panel in digital health and dermatology via a modified Delphi consensus process. A nine-point Likert scale was used to indicate importance of 10 items, and voting was conducted to determine the specific characteristics to include for some items. Consensus was achieved when more than 75% of the experts agreed that inclusion of information was necessary.
RESULTS: There was robust consensus supporting inclusion of all proposed items as minimum labelling requirements; indication for use, intended user, training and test data sets, algorithm design, image processing techniques, clinical validation, performance metrics, limitations, updates and adverse events. Nearly all suggested characteristics of the labelling items received endorsement, except for some characteristics related to performance metrics. Moreover, there was consensus that uniform labelling criteria should apply across all AI categories and risk classes set out by the Therapeutic Goods Administration.
CONCLUSIONS: This study provides critical evidence for setting labelling standards by the Therapeutic Goods Administration to safeguard patients, health professionals, consumers, industry, and regulatory bodies from AI-based dermatology SaMDs that do not currently provide adequate information about how they were developed and tested.

Proposed global definitions of whole grain as an ingredient and whole grain food are presented by the authors on behalf of the Whole Grain Initiative. Whole grains are an important pillar of healthy and sustainable diets. Internationally accepted credible definitions of whole grains as food ingredients and whole-grain foods are necessary to ensure that all global stakeholders have shared standards, and that consumers find them clear, credible, and useful. Based on widely accepted, existing definitions and new developments, the Definitions Working Group of the global Whole Grain Initiative, with experts from academia, government agencies and industry, developed definitions for global application. The key statements of the definition documents are as follows: \"Whole grains shall consist of the intact, ground, cracked, flaked or otherwise processed kernel after the removal of inedible parts such as the hull and husk; all anatomical components, including the endosperm, germ, and bran must be present in the same relative proportions as in the intact kernel\" and \"A whole-grain food shall contain at least 50% whole-grain ingredients based on dry weight. Foods containing 25-50% whole-grain ingredients based on dry weight, may make a front-of-pack claim on the presence of whole grain but cannot be designated \'whole grain\' in the product name\". The definition documents have been ratified by the leading international scientific associations in this area. We urge that these consensus Whole Grain Initiative definitions be adopted as the basis for definitions used by national regulatory authorities and for health promotion organisations worldwide to use in nutrition education and food labelling.

Dietary fibre is a generic term describing non-absorbed plant carbohydrates and small amounts of associated non-carbohydrate components. The main contributors of fibre to the diet are the cell walls of plant tissues, which are supramolecular polymer networks containing variable proportions of cellulose, hemicelluloses, pectic substances, and non-carbohydrate components, such as lignin. Other contributors of fibre are the intracellular storage oligosaccharides, such as fructans. A distinction needs to be made between intrinsic sources of dietary fibre and purified forms of fibre, given that the three-dimensional matrix of the plant cell wall confers benefits beyond fibre isolates. Movement through the digestive tract modifies the cell wall structure and may affect the interactions with the colonic microbes (e.g., small intestinally non-absorbed carbohydrates are broken down by bacteria to short-chain fatty acids, absorbed by colonocytes). These aspects, combined with the fibre associated components (e.g., micronutrients, polyphenols, phytosterols, and phytoestrogens), may contribute to the health outcomes seen with the consumption of dietary fibre. Therefore, where possible, processing should minimise the degradation of the plant cell wall structures to preserve some of its benefits. Food labelling should include dietary fibre values and distinguish between intrinsic and added fibre. Labelling may also help achieve the recommended intake of 14 g/1000 kcal/day.