1. INTRODUCTION
1.1. Purpose of the document
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.
1.2. Intended Purpose
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.
1.3. Intended Medical Indication
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.
1.4. Intended Users and Context
Intended users: healthcare professionals and adult patients.
Intended population: adult human patients during stages of prevention, diagnosis, treatment and/or follow-up of non-critical conditions, as defined in the MDR.
Intended context/environment:
Stress Levels: the device is not intended to be used in high stress situations, such as emergency or critical situations, as its use under those conditions has not been tested; furthermore, such environments are prone to use errors and misuse.
Personal Protective Equipment (PPE): it is not expected that users are wearing any kind of PPE during the use of the device nor the device has been tested in such conditions; however, the device is not expected to misbehave if gloves are being used by the users while using it.
Light Levels: the device is expected to be used in standard light conditions that allow normal working conditions of healthcare professions; for adult patients, no specific light conditions other than does needed to use a personal computer, laptop, or mobile phone have been studied or are recommended.
Noise Levels: the device should be used only in environments that allow a normal conversation in a standard tone.
Facilities: the device is intended to be used in healthcare facilities, home care, or other setting where virtual care provision is deemed safe by the intended user if corresponding to regulations and device requirements, namely in terms of privacy, patient safety, computer and internet availability.
1.5. Product specifications
Medical device name: UpHill® Route
Model: Route
Version: 3.0
Type of medical device: Proprietary standalone Software
UDI: 5600139989009
Basic UDI-DI: 56001399890DSSWS
EMDN Code: V92: Medical device software
1.6. Warnings and cautions
The device should be used only in non-critical conditions.
The device must be used with or above its minimum requirements.
The device should only be used in patients with medical conditions that are compatible with the clinical pathways that are available and if patients meet eligibility criteria.
The clinical decision support features of the device should only be used to inform decision and should always be subject to the clinical judgement of an HCP.
Although the device enables regular updates of clinical pathways, users must always verify if the clinical content is up to date before using the device.
Improper configuration or calibration of the device may result in incorrect or inappropriate recommendations or guidance.
The recommendations or guidance provided by the device are based on the data that is inputted into the device, using interoperability and inputs from the HCP. Incomplete or unreliable data may result in incorrect or inappropriate recommendations or guidance.
Automation features of the device are limited in scope and may not be applicable to certain clinical situations.
Before activation of patient communication features, users must review the recommendation and grant its appropriateness to the specific patient.
Pre-established communication channels will be used to reach the HCP in the event of notifications/alerts being triggered. However, the user must ensure regular checking of the device interface to avoid possible communication channel disruption effects.
In certain situations, the use of the device may pose a risk to the patient's safety, such as if the device fails to recognize a critical condition or if it provides inappropriate recommendations or guidance. As such, the HCP should not become overly reliant on the automation or clinical decision support features of the device and should use their clinical judgment and expertise.
In case of a serious incident related to UpHill Route, the situation should be reported to UpHill (email: support@uphillhealth.com; for address refer to section 1.11 of this document), and the competent authority of the Member State, depending in which country the reportable incident occurred. The contacts of the responsible authorities contacts can be accessed at https://ec.europa.eu/health/medical-devices-sector/new-regulations/contacts_en.
1.7. System requirements
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.
1.8. Data Privacy and Security
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.
1.9. Troubleshooting
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 the 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.
1.10. Document Revision History
The revision history is presented in order to track changes made to this document.
Version | Revision dates | Summary of changes |
1 | May 2023 | - |
2 | Oct 2023 | The Patient Handbook was included in an annex document |
3 | Dec 2023 | Warning and cautions were included |
1.11. Label
Since UpHill Route is a Software as Medical Device, the device label is presented in the following image (Figure 1).
Figure 1. Device label.
2. INSTRUCTIONS
2.1. General description of UpHill Route
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.
Patients can be included and followed in clinical journeys with Hilly communications, which has the following advantages for the patients:
Regular and continuous points of contact with the health teams, giving the patient more autonomy and security.
Greater disease control, due to more frequent monitoring by the health team, which is reflected in a lower risk of complications and hospitalizations and, consequently, a better quality of life.
Anticipation of care and potentially better outcomes, that is early identification of alarm signs and timely intervention by the medical team.
Reduction in trips to the hospital or other health facility and consequent reduction in costs associated with these trips.
Reduction of waiting times between moments of care.
Greater access to the health team.
2.2. Patient Communication
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 3), email (Figure 2) 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.
Figure 2. Email received of a Hilly communication.
Figure 3. SMS received by a Hilly communication.
If patients decide to go to the webpage (available on desktop and mobile platforms), they access an initial page, where the patient must consent the treatment of the personal data, by clicking on the checkbox (Figure 5, Figure 4).
Figure 4. Initial page of a webform (mobile version).
Figure 5. Initial page of a webform (computer version).
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.
Figure 6. Example of a data input in the patient webpage.
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.
Figure 7. Message when a communication has already been answered and the user accesses the webform.
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.
Figure 8. Message when a communication is inactive, and the user accesses the webform.
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).
Figure 9. Message when a communication is cancelled, and the patient accesses the webform.
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.
2.3. FAQs
In this section some frequently asked questions from patients and corresponding answers are presented.
What do I do if I cannot answer the call?
If you can't answer, don't worry, at any time you can always call back or click on the form link to continue. If information is not received within 4 hours, you will be contacted again via phone call and/or email. This can be repeated up to a maximum of 3x/day.
How much time do I have to reply?
After being contacted, you must reply as soon as possible and within a maximum period of 14 days. If you don't, don't worry: wait for the next contact and answer the questions in the way that is most convenient for you.
Can I change the way I reply halfway through?
You can always interrupt the phone call and go to the online form if you wish, and vice versa. If we do not have access to your mobile phone number, this operation will not be possible, only the online form will be available.
What if I make a mistake when answering the communication?
Contact us by the means indicated in the email or via customer support whenever necessary. Don't worry though, mistakes are completely normal.
What do I do if the call drops midway through?
If for some reason the call is dropped or interrupted, you will receive an SMS informing you that the call was not successfully completed. To do so, you must call the number or click on the link in the form to continue. If you provided your home number and not your mobile number, you will not receive any SMS.
END OF DOCUMENT