SmartPDT-P

The SmartPDT®-P app is the patient interface of SmartPDT®, siHealth’s digital solution for the daylight Photodynamic Therapy (dPDT) of Actinic Keratosis (AK).

SmartPDT® is a CE marked software medical device class I, compliant to the European Medical Device Regulation 2017/745 and fully compliant to data protection regulations (e.g. GDPR). It’s based on the siHealth’s patented technology for the sensor-less monitoring of solar radiation, anywhere and anytime (https://www.happysun.co.uk).

SmartPDT® enables the use of daylight Photodynamic Therapy (dPDT), the natural alternative method to conventional laser or lamp photodynamic therapy, in a safe and reliable way from remote.

The SmartPDT®-P app can be used only by patients that received access credentials generated on the SmartPDT®-D web-portal by their healthcare providers. More information for activating a SmartPDT® account can be found at https://www.smartpdt.com or by contacting us at [email protected].

Main features of SmartPDT®-P

- Sensorless solar radiation monitoring: SmartPDT®-P uses the HappySun® technology (https://www.happysun.co.uk), siHealth’s innovative satellite-based solar radiation dosimeter, to continually measure the solar radiation dose incident on the patient’s skin, anywhere and anytime

- Personalised sun protection: solar radiation monitoring, combined with patient’s phototype and sunscreen applied, allows SmartPDT® to assure a skin erythema-free (sunburn-free), safe and effective dPDT therapy session to any patient

- Remote patient monitoring during dPDT: the app enables dermatologists and clinicians to monitor their patients' progress remotely, proactively adjust actinic keratosis treatment plans, supervise the protocol adherence by the patient during and after the therapy session and stay connected between visits

- Patient support: SmartPDT®-P gently guides patients on when and how to prepare their treatment session, using notifications and alerts to when the patient needs to start and finish their treatment, ensuring that both treatment and aftercare protocol procedures are followed

- Scientifically and clinically validated: SmartPDT® uses satellite imagery and computer algorithms to determine in real-time the exposure to PpIX-effective visible and ultraviolet solar radiation, ensuring accurate and precise readings; the accuracy of siHealth’s technology has been scientifically demonstrated by dedicated studies performed in the UK in collaboration with the University of Dundee, NHS Tayside and the UK Health Security Agency (formerly Public Health England).

Medical device

SmartPDT® is a software medical device class I, compliant to the European Medical Device Regulation 2017/745 and developed in accordance with the IEC 62304:2006 standard (“Medical device software - Software life cycle processes”).

SmartPDT®-P app

Medical device name: SmartPDT®

Model: SmartPDT®-P iOS App

Version/Reference: 1.0

Date of release: 28th October 2020

Unique Device Identification (UDI): (01)05060861070012(8012)1.0

Risk Class: Class I

Manufacturer and maintainer:

siHealth Ltd.

Building R104, RAL, Harwell Campus, Didcot, Oxfordshire, OX11 0QX, United Kingdom

Website: www.siHealth.co.uk

Email: [email protected]

Phone number: +44 (0) 1865 589309

EU Authorised Representative, Importer and Distributor in the European Union (EU):

siHealth Photonics S.r.l.

Via Lampredi 45, Livorno, 57121, Italy

Website: www.siHealthPhotonics.it

Email: [email protected]

Phone: +39 0586 097801

Data Protection & GDPR compliance

SmartPDT® is fully compliant to the General Data Protection Regulation (GDPR – EU Regulation 2016/679) and to applicable data protection laws. All information collected on users within this product is subject to dedicated Terms of Use, Privacy Policy and consent forms.

siHealth Ltd is officially registered in the Data Protection Register of the United Kingdom’s Information Commissioner's Office (ICO) with registration number ZA834797.