Region Skåne’s new digital tools were not registered with the Medical Products Agency

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On 28 May this year, Region Skåne hastily purchased the digital tool Platform24. Two weeks later, the IT system, intended to strengthen care during the pandemic, began to be used via Primary Care Skåne online.

With the help of the tool, the Scanian patients can via the health centre’s website or 1177.se digitally contact or chat with a nurse or doctor for assessment, prescription or appointment.

Started supervision

When SVT Nyheter Skåne contacted the Medical Products Agency about Platform24 on 8 July, they had just been told that Platform24 was not registered with the Medical Products Agency.

The authority therefore started an inspection of the manufacturer and on 9 July, the Medical Products Agency confirmed that Platform24 Healthcare AB had submitted a registration.

Just “a name change”

According to the company, the IT tool was registered as early as 2017 but under a different name.

“The registration of the product Platform24 (former name Healy) took place several years ago and has been in companies within the Doktor24 Group throughout the product’s life,” writes Sara Dannborg, communications manager at Platform24, in an email to SVT.

Believe in the explanation

The Medical Products Agency emphasizes that it is important with correct registration and that registration or change must be made in connection with a name change or change of ownership.

Since the company finally registered Platform24, the Medical Products Agency has now discontinued the supervision without imposing any sanctions. However, the authority cannot confirm whether it is one and the same product.

“The Medical Products Agency can not comment on this with certainty as neither Healy nor Platform24 has been examined in detail,” writes Ewa-Lena Hartman, group manager in medical technology at the Medical Products Agency, in an email to SVT.

No problems for Region Skåne

How could Region Skåne buy a medical device that was not registered with the Medical Products Agency?

– We have examined the product from Region Skåne’s perspective and see no patient safety risks. This is unproblematic for us, says Niklas Gustafsson, operations manager for digitization IT and MT within Region Skåne, to SVT.

According to the company’s website, a number of Swedish regions in addition to Skåne have purchased the system, including Norrbotten, Västerbotten, Jämtland / Härjedalen, Sörmland, Västmanland and Gävleborg.



Source link
https://www.svt.se/nyheter/lokalt/skane/region-skane-nya-digitala-verktyg-saknade-godkannande-av-lakemedelsverket

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