The Patient Handbook serves as a comprehensive guide for patients using the device under the MDR certification process. It provides essential information, instructions, and guidance to patients on how to effectively and safely use the device to manage their health and well-being.

UpHill® Route is a clinical pathway software medical device with the purpose of aiding clinical decision-making and/or automating pre-approved clinical and/or non-clinical tasks, based on locally validated clinical pathways, to be used by healthcare professionals and by adult patients, during prevention, diagnosis, treatment and/or follow-up of non-critical medical conditions.

UpHill® Route is intended to be used during prevention, diagnosis, treatment and/or follow-up phases of any non-critical medical condition. This EXCLUDES any situation or conditions where accurate and/or timely diagnosis or treatment action is vital to avoid death, long-term disability, or other serious deterioration of health of an individual patient or to mitigate impact to public health. The type of disease or condition MUST NOT be a life-threatening state of health, nor require major therapeutic interventions. Targeted patients MUST NOT be fragile with respect to the disease or condition and must be EXCLUDED IF do not have access to a mobile phone or internet browser; present cognitive impairment that prevents the provision of medical history in the absence of a caregiver.

Intended population: adult human patients during stages of prevention, diagnosis, treatment, and/or follow-up of non-critical conditions, as defined in the MDR.

UpHill® Route is a clinical management software, supported by all operative systems versions of the device (a computer or tablet). It relies on a network connection for access, ensuring a stable and easily accessible internet address for users.

UpHill Route is designed and developed to comply with the General Data Protection Regulation (GDPR) and other relevant EU data protection regulations. Data processing activities adhere to the principles of lawfulness, fairness, transparency, purpose limitation, accuracy, storage limitation, integrity, and confidentiality. UpHill’s Data Protection Officer can be reached at dpo@uphillhealth.com.

UpHill employs comprehensive security measures to protect user and patient data from unauthorized access, disclosure, alteration, or destruction. Also, UpHill maintains a comprehensive information security policy that outlines security practices, employee responsibilities, and incident response procedures to ensure a proactive and robust security posture. UpHill complies with the best Information Security standards through ISO 27001 certification (for more information visit: https://uphillhealth.com/security-compliance).

Regarding patient data collection, the device collects and processes patient data strictly for specified and legitimate purposes. The device provides mechanisms for patients to exercise their rights, including the right to access, erase, or restrict the processing of their personal data. UpHill’s Terms of Use, Terms and Conditions, Privacy Policy and Cookies Policy are available at https://www.uphillhealth.com/terms-policies.

Patients are informed by email of a contact to use in need of technical support. Also, UpHill provides customer service, through a chat provided in UpHill website at https://support.uphillhealth.com/en/, which is available from 9am-18pm (Lisbon time), although it is possible to send a message at any time.

The revision history is presented in order to track changes made to this document.

Since UpHill Route is a Software as Medical Device, the device label is presented in the following image (Figure 1).

UpHill® Route is an interoperable clinical pathway-based and patient-specific decision support system software with automation of orders and patient communication, intended to be used by and assist healthcare professionals (HCP or users) in making informed clinical decisions for diagnosis, prevention, monitoring, treatment, or alleviation of non-critical medical conditions in adult patients (excluding critical conditions as defined by the International Medical Device Regulators Forum) by facilitating clinical and non-clinical tasks. UpHill® Route enables the user to (i) track and provide a record of a patient in a clinical pathway; (ii) support users in clinical decision-making; (iii) asynchronously collect and interpret patient-reported data; (iv) generate alerts of changes in clinical status of the patient; (v) issue patient-directed recommendations or information; (vi) automate pre-defined clinical or non-clinical tasks; and (vii) manage patient groups on clinical pathways. 

Regarding communications, UpHill® Route supports patient-physician communication, through a virtual assistant – Hilly -, allowing patients to report symptoms and contact their clinical team without the need to travel to the health institution.

When a communication is sent to the patient, the patient will be contacted, with the defined recurrence and frequency of contacts, by the available channels. Depending on the contacts provided by the patient, the patient can be contacted by SMS (Figure 2), email (Figure 3) or both. In both the email and SMS, there is a link to access the webpage. Additionally, in the SMS, in some cases, the patient can ask to be contacted by Hilly using programmed phone calls.

If patients decide to go to the webpage (available on desktop and mobile platforms), they access an initial page, where the patient must consent to the treatment of the personal data, by clicking on the checkbox (Figure 4, Figure 5).

Note that files can be attached to the webpage to be downloadable by the patient. After accepting the storage and processing of data, the page(s) in which they must provide all required information are presented, as shown in Figure 6.

Note that a communication can include multiple points of contact, but each point of contact can only be answered once. In case the communication was already answered but the user clicks on the web forms again, a new screen (Figure 7) explaining the answers have been already recorded is displayed to the user

Also, a communication has a valid period for the patient to answer. In case the user tries to answer a communication after the valid period, or after receiving a new communication, the user is prompted with the message displayed in Figure 8.

In turn, when a communication is canceled and the user tries to access the webform, the user is presented with the following screen (Figure 9).

As explained before, the patient can also answer the communication by phone call. In that case, the patient should answer the SMS received with the defined word (in the example given, “CALL”). Then, the patient will be contacted by a virtual assistant who will ask questions to be patient and give instructions on how to answer. The patient can answer by voice or typing on the cell phone keyboard.

In case the patient does not answer the communication (by webform or call), there is the possibility of being contacted by call in the following hours.