Evolving regulatory perspectives on digital health technologies for medicinal product development.

Digital health technology tools (DHTTs) present real opportunities for accelerating innovation, improving patient care, reducing clinical trial duration and minimising risk in medicines development. This review is comprised of four case studies of DHTTs used throughout the lifecycle of medicinal products, starting from their development. These cases illustrate how the regulatory requirements of DHTTs used in medicines development are based on two European regulatory frameworks (medical device and the medicinal product regulations) and highlight the need for increased collaboration between various stakeholders, including regulators (medicines regulators and device bodies), pharmaceutical sponsors, manufacturers of devices and software, and academia. As illustrated in the examples, the complexity of the interactions is further increased by unique challenges related to DHTTs. These case studies are the main examples of DHTTs with a regulatory assessment thus far, providing an insight into the applicable current regulatory approach; they were selected by a group of authors, including regulatory specialists from pharmaceutical sponsors, technology experts, academic researchers and employees of the European Medicines Agency. For each case study, the challenges faced by sponsors and proposed potential solutions are discussed, and the benefit of a structured interaction among the different stakeholders is also highlighted.

Successful Diagnosis of a Longstanding Giant Amoebic Liver Abscess Using Contrast-Enhanced Ultrasonography (CEUS): A Case Report in a Western Country.

BACKGROUND E. histolytica liver abscess results from extra-intestinal diffusion of amebiasis, which is responsible for up 100 000 deaths per annum, placing it second only to malaria in mortality. Currently, the criterion standard for the diagnosis of liver abscesses is ultrasound, but CEUS (contrast-enhanced ultrasound) is emerging as a more accurate method for liver study, and it could be more accurate than ultrasound and non-invasive compared to CT. CASE REPORT A white man (59 years old) with a 2-day history of dyspnea, acute abdominal pain in right upper quadrant, and raised inflammatory markers was admitted to a second-level Emergency Department in Rome (Italy). He reported several trips to tropical areas many years before, during which he ingested non-potable water and became infected with Entamoeba histolytica. This was treated medically with success. After administration of antibiotics (meropenem and metronidazole), a liver CEUS (contrast-enhanced ultrasonography) with administration of SonoVue (sulphur hexafluoride microbubbles) confirmed a giant liver abscess (15×16 cm). One day later, CT-guided drainage was performed without complications and the patient was discharged on the 25th post-procedure day, with improved blood results. CONCLUSIONS Acute abdominal pain can be caused by a variety of diseases, but a diagnosis of parasitic abscess should not be overlooked in non-endemic Western countries. CEUS is a new, promising, and more accurate technique that can be utilized to recognize liver abnormalities, including abscesses; however, retrospective population-wide studies are necessary to define the differential diagnoses.