Boutique Diagnostics

Digital Health Market Access Consulting Firm

Digital Health Solutions

June 2022: What’s new in the world of diagnostics? – (Digital) diagnostics access / policy news around the globe

In June 2022, we have identified the following access and policy-relevant news that caught our attention from the (digital) diagnostics perspective. Check them out:

1.       Nordic region to share unified digital health standards

A digital health and evaluation criteria program has been launched across Sweden, Denmark, Norway, Finland, and Iceland, with an aim to unify digital health standards.

2.       Government publishes final data strategy for healthcare (UK)

The strategy focuses on seven principles to harness the data-driven power and innovation seen during the pandemic to drive transformation.

3.       AOK Federal Association / AOK welcomes planned regulations on care apps (DE)

The AOK Federal Association has welcomed the planned regulations on digital care applications (DiPAs), the costs of which are to be reimbursed by the long-term care insurance funds in the future.

4.       Cervical carcinoma: The sole HPV test has proven effective in screening in England

The move from cytology to HPV screening, which detects infection with the oncogenic variants of the human papillomavirus (HPV) earlier, has proved its worth in England.

5.       Early and compassionate access: the two new Cnil standards expected in September (FR)

The National Commission for Computing and Liberties (Cnil) has postponed the final adoption of two new standards relating to early access or compassionate access procedures until September, in particular, because of "two to three points that remain to be clarified”.

6.       NHS Scotland patients to benefit from fast-track innovation scheme (UK)

NHS Scotland has launched a new initiative designed to speed up the development, assessment, and roll-out of proven technological innovations to healthcare staff.

7.       A quick regulatory guide to telehealth services in Japan

This article highlights some regulatory issues that non-physician service providers need to be aware of.

8.       NICE endorses Magtrace diagnostic to detect breast cancer spread (UK)

Women with breast cancer in England and Wales will soon be able to access a new diagnostic based on an injectable magnetic marker liquid called Magtrace that will identify if the disease has spread around the body.

9.       Hospitals make new proposals to reform outpatient emergency care (DE)

The German Hospital Society (DKG) has presented positions on the reform of outpatient emergency care. The DKG proposes setting up an integrated emergency center (INZ) at all hospital locations that meet the requirements of the Federal Joint Committee (G-BA) for the inpatient emergency classification system, which includes both a portal practice and an emergency outpatient department at a common counter.

10.   Compensation for HPV test will be increased from July (DE)

HPV testing for the early detection of cervical cancer will be remunerated at a higher rate from July 1st, as decided by the evaluation committee (BewA).

11.   Moovcare joins Lifen Platform (FR)

The Moovcare remote monitoring solution integrates with Lifen Platform to allow better patient benefit and more responsive interventions by medical teams. Moovcare, the first digital therapy to be officially reimbursed by the health authorities in France