In September 2022, these access and policy-relevant news pieces caught our attention from the (digital) diagnostics perspective. Check them out:
1. Health policy — Europe advocates organized screening for lung, prostate and stomach cancers
In new recommendations, the European Commission advocates expanded and better quality screening. In addition to screening for three additional cancers, it proposes in particular to extend breast cancer screening to more women.
2. FDA finalizes guidance on how clinical decision support software is regulated
The Food and Drug Administration has published final guidance on determining whether clinical decision support software is considered a medical device. The final text diverges significantly from the draft released in 2019
3. Biomarker Test Access for Precision Oncology Varies Widely in Europe, ESMO Survey Finds
A survey of 53 European countries has captured the variable access cancer patients have to molecular tests that are increasingly necessary for personalized therapy.
4. Hospital reform: Lauterbach wants every fourth inpatient treatment to be outpatient (Germany)
Hospitals should be allowed to carry out all suitable treatments as day treatment from January. Federal Health Minister Karl Lauterbach (SPD) is planning this after the hospital commission has drawn up a corresponding recommendation. Remuneration is to be regulated by adjusting the diagnosis-related flat-rate system (DRG).
5. Illumina opens first manufacturing facility in China to supply gene sequencing products (China)
Illumina has opened its first manufacturing facility in China, enabling it to make gene sequencing instruments and consumables for the local market. The facility in Shanghai initially will produce 16 sequencing reagents for clinical use.
6. Innovation - Progress report on the transitional reimbursement mechanism for medical devices (France)
Since February 23, 2021, the transitional reimbursement mechanism (PECT) makes it possible to make eligible for reimbursement, for one year, medical devices that meet a need that is not or poorly covered in the context of serious or rare diseases, or in compensation for a disability. Since its launch, HAS has given a positive opinion to four of the eight files submitted to it and others are being assessed. Update on a mechanism that allows rapid access to innovations for patients in a therapeutic impasse.
7. National coronary artery disease care guideline updated (Germany)
The new version 6.0 of the national health care guideline (NVL) for chronic coronary heart disease (CHD) has been published. A working group from 18 specialist societies and organizations has revised the chapter on revascularization for the new edition.
8. The much-needed harmonisation between the AI Act and MDR/IVDR
This new proposal has raised many concerns such as if medical devices using AI shall also be notified to other bodies and the liability regime applicable to medical device manufacturers.
9. Calls for new health technology and life sciences strategy in Ireland
BioPharmaChem Ireland and Irish Medtech Association, the Ibec groups that represent the sectors, has launched a joint Budget 2023 submission advocating for the Government to develop a national health technology and life sciences strategy with appropriate resources to manage its implementation.
10. Forget oximeters, smartphone cameras detect 79% of cases of low blood oxygen in small study
An unmodified smartphone camera has detected 79% of cases of abnormally low blood oxygen levels in a six-subject study. The research, details of which were published in the journal npj Digital Medicine, expands on earlier smartphone-based oximetry projects by studying blood-oxygen saturation levels of as low as 70%.