Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges.

Objectives: Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular attention is paid to software-based in vitro diagnostics (IVDs). With this point of view, a strong connection between DTx and IVDs is observed. Methods: We investigated the current regulatory scenarios and reimbursement approaches adopted for DTx and IVDs. The initial assumption was that countries apply different regulations for the access to the market and adopt different reimbursement systems for both DTx and IVDs. The analysis was limited to the US, European countries (Germany, France, and UK), and Australia due to maturity in digital health product adoption and regulatory processes, and recent regulations related to IVDs. The final aim was to provide a general comparative overview and identify those aspects that should be better addressed to support the adoption and commercialization of DTx and IVDs. Results: Many countries regulate DTx as medical devices or software integrated with a medical device, and some have a more specific pathway than others. Australia has more specific regulations classifying software used in IVD. Some EU countries are adopting similar processes to the Digital Health Applications (DiGA) under Germany's Digitale-Versorgung Gesetz (DVG) law, which deems DTx eligible for reimbursement during the fast access pathway. France is working on a fast-track system to make DTx available to patients and reimbursable by the public system. The US retains some coverage through private insurance, federal and state programs like Medicaid and Veterans Affairs, and out-of-pocket spending. The updated Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the EU includes a classification system specifying how software integrated with medical devices, and IVDs specifically must be regulated. Conclusion: The outlook for DTx and IVDs is changing as they are becoming more technologically advanced, and some countries are adapting their device classifications depending on specific features. Our analysis showed the complexity of the issue demonstrating how fragmented are regulatory systems for DTx and IVDs. Differences emerged in terms of definitions, terminology, requested evidence, payment approaches and the overall reimbursement landscape. The complexity is expected to have a direct impact on the commercialization of and access to DTx and IVDs. In this scenario, willingness to pay of different stakeholders is a key theme.

Parallel imports and innovation in an emerging economy: the case of Indian pharmaceuticals.

This paper studies the impact of the re-importation of imitated pharmaceuticals as a by-product of an open policy toward parallel import (PI) on process innovation. Foreign investment by a firm to exploit a new unregulated market with weak intellectual property rights can give rise to imitation. These products can potentially re-enter the original country when PI is allowed influencing research and development (R&D) incentives. In an emerging economy with technologically heterogeneous firms, trade costs shift PI-related market share losses from the more to the less R&D efficient firm, inducing the former to strategically increase R&D. PI accompanied by tariffs also induces higher R&D effort by the technologically inferior firm when it results in an expansion of its sales abroad. A tariff on PI is most likely to increase welfare when the technological gap between the two firms at home is sufficiently large.

Evaluation of the dose to pediatric patients undergoing micturating cystourethrography examination and optimization of the examination.

PURPOSE: The aim of our work was to estimate the dose to paediatric patients undergoing micturating cystourethrography (MCU), and to optimize those examination procedures that were found to be particularly significant from the point of view of the radiation dose. At the same time it was also decided to evaluate the absorbed dose to the parents, who frequently assist the child during MCU. MATERIALS AND METHODS: The study was carried out on 220 children undergoing micturatig cystourethrography, by measuring in vivo the dose equivalent entering and exiting from the patient with thermoluminescent dosimetry and the KAP (Kerma Area Product). From the latter, the imparted energy and the average absorbed dose to the patients were subsequently calculated. RESULTS: The average absorbed dose was 0.69+/-0.54 mGy, with a variation interval of 0.126-3.110 mGy. A remarkable dispersion of the absorbed dose values was observed, also for subjects of similar size. This indicates that radiation protection of paediatric patients still allows for wide margins of optimization. In fact it was possible to verify that the dose depends not only on the size of the child, but also on his/her degree of cooperation, and on the technical ability of the operator. The latter aspect was estimated by comparing the doses delivered by two different physicians; differences by a factor of 5 were observed. The application of additional filtration of 2 mm of Al (total 5 mm Al) concurred to a dose reduction without significant variations in image quality. The effective dose received by the parents present during the examination was 4+/-7 microSv. CONCLUSIONS: A specific feature of paediatric MCU is not only the amount of radiation dose, often not negligible, but also the remarkable variation of the dose values, even within the same age group. The specialist has an important role in the justification of the examination: the adoption of a specific protocol has allowed reduction of the number of children undergoing MCU. Optimization of the examination requires quality control on the equipment, as well as the adoption of good radiographic techniques and the provision of suitable environments for children. The present study has helped to focus the attention of practitioners on radiation protection and, consequently, to reduce the dose delivered to the children. The effective dose received by the parents showed that their presence can be justified provided that they are adequately protected.