In October 2022, we have identified the following access and policy-relevant news that caught our attention from the (digital) diagnostics perspective. Check them out:
1. EU Medical Devices Regulation is to be improved - EU
The EU Commission will present proposals for adjustments to the MDR this year. German CDU politician, Liese, highlighted that such an adjustment package should contain more than a "mere extension of the deadline" and includes, for example, an expansion of the capacities of the certification bodies.
2. Consortium Aims to Standardize IHC Biomarker Tests for Precision Medicine, Starting With HER2 - US
The Consortium for Analytic Standardization (CASI) has unveiled its plan, funded by a $2 million grant from the National Cancer Institute, to standardize immunohistochemistry tests, particularly for biomarkers tied to US FDA approved precision oncology products.
3. Opportunities and challenges of integrated care systems - UK
At present, the inherent tension between meeting national targets and addressing local needs, the challenging financial savings targets, the longstanding workforce issues and wider pressures on the system, particularly social care, mean that there is a high risk that ICSs will find it challenging to fulfil the high hopes many stakeholders have for them.
4. Primary care pressures facing integrated care systems - UK
This report identifies 16 of 42 regions where primary and secondary care services are under high levels of pressure going into this winter. The research finds widespread variation in access to services including a nearly four-fold variation in the proportion of patients waiting three weeks or more for a GP appointment.
5. GKV in the stress test: Health insurance companies fear competition from tech companies - Germany
With the emergence of a digital health ecosystem, new prevention offers and individualized therapies, the statutory health insurance is facing significant changes. A PwC study examines the challenges facing statutory health insurance companies up to the year 2030.
6. New fee schedule position for gynecological cytology from January - Germany
Resident gynecologists will in future be able to bill for curative immune-cytological examinations of the cervix.
7. Health insurance contributions are likely to increase significantly - Germany
The contributions are now to be raised by 0.3 percentage pointsThe aim of the new regulations is to financially stabilize statutory health insurance (GKV). The deficit of the GKV is estimated at around 17 billion euros for 2023.
8. ANSM recommendations on the cybersecurity of medical devices - France
Recommendations on the cybersecurity of medical devices (MD) integrating software during their life cycle were published by the National Agency for the Safety of Medicines and Health Products (ANSM).
9. Consultation of the new version of the digital health doctrine (ANS) - France
Published as part of the digital health roadmap, the technical doctrine aims to provide a technical framework where digital services for the exchange and sharing of health data will have to fit "in target and in trajectory".