Instructions for Use

Medicilio RPM

Remote Patient Monitoring software — Clinician Manual

Symbol	Particular	Value
Manufacturer	Manufacturer	Cantieri Digitali Medtech S.r.l., Corso di Porta Romana 6, 20122 Milano (IT), VAT/P.IVA IT11328810962
Caution	Consult the Instructions for Use	This document
UDI	UDI-DI	[UDI-DI placeholder to be assigned before placing on market]
MD	Device category	Medical Device: Class IIa software (MDSW)
REF	Trade name	Medicilio RPM
Version	Software version	1.0.0
CE	CE mark	[CE-NUMBER placeholder] · Notified Body: [NB-NUMBER placeholder]
Date	Date of issue	2026-09-07
eIFU	Electronic IFU	Available at https://ifu.medicilio.it per Regulation (EU) 2021/2226

EU MDR 2017/745 · Class IIa Medical Device Software (MDSW)
Software version 1.0.0 · Date of issue 2026-09-07
Cantieri Digitali Medtech S.r.l. · Corso di Porta Romana 6, 20122 Milano (IT)

1. Introduction

1.1 About the product

Medicilio RPM is a software medical device intended for the remote monitoring of patients enrolled in a clinician-prescribed care pathway. It collects measurements from compatible connected medical devices and from manual patient input, evaluates each measurement against clinician-set thresholds, raises alerts when thresholds are breached, and supports clinicians in producing AI-assisted telemonitoring reports that they must review and sign before any report is released to the patient.

Medicilio RPM is qualified as Medical Device Software (MDSW) per MDCG 2019-11 and is classified as Class IIa under EU Regulation 2017/745 (MDR).

1.2 About this manual

This document is the Instructions for Use (IFU) for Medicilio RPM. It combines the regulatory IFU content required by Annex I §23 of the MDR with the operational depth required by the intended users to operate the device safely.

1.3 Hardware, software and network specifications

Medicilio RPM is delivered as two end-user applications that connect to the manufacturer's cloud back end:

The "label" of a software medical device is the in-app device-identification screen, which carries the device identification per §23.2 and §23.4(a). In the clinician web application it is the account dropdown in the top bar, which states that Medicilio RPM is a medical device and shows the software version and the device UDI. The same dropdown carries a User Manual entry that opens the current electronic Instructions for Use.

2. Contact details

2.1 Manufacturer

Cantieri Digitali Medtech S.r.l. Corso di Porta Romana 6 20122 Milano (MI), Italy VAT / P.IVA IT11328810962

2.2 Technical and clinical support

2.3 Feedback

Feedback on these Instructions for Use, or on the device, may be sent to info@medicilio.it. Feedback is not a substitute for the serious-incident reporting procedure described in §18.

2.4 Request a paper copy

These Instructions for Use are delivered electronically as permitted by Regulation (EU) 2021/2226. A printed copy is available, at no charge, within 7 calendar days of a written request sent to the support email above.

The current electronic Instructions for Use can also be opened from inside the applications (see §1.3). Each link resolves to the edition matching the user type, in the language of the application.

3. Definition of symbols and precautions

The following symbols are used on the cover page and throughout this document, in accordance with ISO 15223-1:2021. Where a harmonised symbol does not apply, a description is provided in this section.

The IFU also uses four in-text callouts to draw attention to information of different criticality:

4. Warnings

The following warnings apply to all users of the device.

5. Intended use

5.1 Product name

Medicilio RPM : Remote Patient Monitoring software, software version 1.0.0.

5.2 Intended use / Intended purpose / Indications for use

Medicilio RPM is a medical device software platform intended for remote monitoring of adult patients by receiving, transmitting, storing, and presenting physiological parameter measurements from compatible connected devices and patient-reported data entered by the patient, to support healthcare professionals in clinical follow-up and chronic disease management.

Medicilio RPM includes an AI-assisted report generation function that produces draft summaries of patient data for review by a healthcare professional.

Medicilio RPM does not itself perform physiological measurements; physiological measurements are provided by the connected devices.

5.3 Intended user profile

Medicilio RPM addresses two target client populations: (1) healthcare provider organisations (hospitals, clinics, independent practices) that prescribe and operate the pathway, and (2) patients assigned to a pathway.

Per the Intended Use and Use Specification, users fall into three categories: Clinical Users (§5.3.1, §5.3.2), and Lay Users (patients).

Within each client, the device has the following intended users.

5.3.1 Head of Department, Department Doctor, Independent Practice Doctor (Clinical User)

5.3.2 Healthcare Professional (Clinical User)

5.4 Intended operational environment

Medicilio RPM is operated in two environments:

• The clinician environment: a clinical office or remote workstation with a managed computer, controlled physical access, and a stable network connection.
• The patient environment: the patient's home or any location in which the patient can use their provided tablet with mobile data or Wi-Fi connectivity.

The device is not intended to be used in operating theatres, intensive care units, or in any environment where life-supporting decisions must be made in real time.

5.5 Intended patient population

Adult patients (18 years of age and older) requiring remote monitoring as part of clinical follow-up or chronic disease management. Patients must be able to use the mobile application, or have a designated caregiver acting on their behalf, and must have been prescribed a remote-monitoring pathway by an authorised clinician.

5.6 Intended clinical benefits

Candidate clinical benefits:

• Earlier detection of out-of-range vital parameters in the home setting, supporting timely clinical intervention.
• Improved adherence to the prescribed care pathway through structured reminders and activity scheduling.
• Increased continuity of care between in-clinic visits via documented telemonitoring and AI-assisted reports reviewed by a clinician.

5.7 Performance characteristics

Medicilio RPM is not a measuring device in itself: it records, evaluates and presents measurements taken by compatible connected medical devices listed in §6, each carrying its own CE marking and its own accuracy specification. The performance characteristics of Medicilio RPM are:

• Threshold evaluation: each measurement is compared against the per-pathway thresholds; if a high, low, weight-variation or boolean threshold is breached, an alert with the corresponding level is recorded.
• Alert routing: red-level alerts create a schedule notification for Medicilio Customer Support and caregivers notifications via job queues.
• Report generation: telemonitoring reports are drafted by an AI component and require clinician review, editing and electronic signature before being released to the patient.

5.8 Contraindications

• Use in any clinical situation requiring real-time monitoring (e.g. ICU, perioperative care).
• Use as the sole monitoring modality for a patient whose clinical condition requires continuous in-person observation.
• Use in patients with a cardiac pacemaker or other active implantable cardiac device, when the prescribed pathway includes a bioimpedance-based body composition scale.

6. Compatible medical devices and accessories

Who can perform this action (associating devices to a pathway): Department Doctor, Independent Practice Doctor, Department Doctor Head, Medicilio Customer Support, Ops.

6.1 Compatible measurement devices

Medicilio RPM is used with a configured patient home kit. The devices included depend on the monitoring pathway prescribed to the patient.

Each device has its own Instructions for Use. The user must follow the device manufacturer's IFU for setup, positioning, cleaning, calibration, battery handling, warnings, contraindications, and maintenance.

6.1.1 Medical devices

Medicilio RPM connects to CE-marked medical devices, across the following categories:

• Pulse oximeters
• Blood-pressure monitors (with or without integrated ECG)
• ECG recorders
• Infrared thermometers
• Spirometers
• Body-composition / weight scales

Each device retains its own CE marking, accuracy specification, and manufacturer's Instructions for Use, which must be followed for setup, positioning, cleaning, calibration, battery handling, warnings, contraindications, and maintenance (see the IMPORTANT note below).

The current list of compatible devices is kept updated and is available to users upon request by contacting Medicilio support (see §2.2).

6.1.2 Non-medical wellness devices

Medicilio RPM may also ingest data from non-medical wellness devices in the following categories: smartwatches (step count, heart rate) and body-composition scales. These devices are not regulated as medical devices; their manufacturers explicitly declare this, and their accuracy claims (where present) are wellness-grade, not clinical-grade. The specific models currently in use are available upon request by contacting Medicilio support (see §2.2).

6.2 Patient tablet (MDM-locked): Lenovo Tab M11

The patient receives, as part of the home kit, a tablet on which the Medicilio patient application is preinstalled. The tablet is locked by a Mobile Device Management (MDM) tool so that only the Medicilio application can run on it; navigation outside the app, installation of other applications, and access to the operating system are not permitted.

6.3 Measurement types

Medicilio RPM supports the following measurement types:

• Blood pressure (systolic / diastolic)
• ECG (electrocardiogram trace + interpretation flags)
• Heart rate
• Oxygen saturation (SpO₂)
• Body temperature
• Body weight
• Step count
• Peak expiratory flow (PEF, in litres per minute; the other spirometry parameters a spirometer can produce are not ingested)

6.4 Associating devices and configuring the kit

Who can perform this action: Medicilio Customer Support, Ops.

Procedure — Configure the kit before shipment (Medicilio Customer Support)

1. In the clinician web app, open the pathway and select the Info tab. The tab presents the device list, the network configuration, the shipping information and the patient information as separate cards.

2. Click edit on the device card, pick the measurement and the device serial number from stock, and confirm. Each selected serial number is bound to the pathway as a measurement source.

3. Click edit on the network card, select the connectivity configuration type, enter the home gateway identifier, the tablet brand (Lenovo) and serial number, and the SIM details (number, PIN, PUK) than save.

The network card records which of two connectivity configurations the kit uses. In the Router configuration the SIM is in a Wi-Fi router, so measurements reach the platform while the tablet is switched off. In the Hotspot configuration the SIM is in the tablet, which serves the gateway, so connectivity depends on the tablet being on. The configuration type is visible to clinicians on the pathway's Info tab.

One gateway can serve more than one patient, provided every patient sharing it is registered at the same address. Attaching a gateway to a second pathway at a different address is rejected. Each patient sharing a gateway must have their own devices bound to their own pathway: a measurement is attributed by the device that produced it, not by the gateway that relayed it.

4. Click Edit in the shipping card, set the courier and the tracking number, then save.

5. Once devices, network and shipping are all set, transition the pathway to the status "kit to be shipped" . The patient receives the kit at the registered address and activates the pathway.

Procedure — Replace a faulty device (Medicilio Customer Support)

1. From the pathway's Info tab, open the Devices card.
2. Select the faulty device's row and click Replace
3. Pick the replacement serial number from stock and confirm.

6.5 Manual patient entry

When a connected device is unavailable or has failed, the patient may enter a measurement manually in the app. See §9.7 for how manual entries appear to the clinician, and the warning "Verify device suitability" in §4.

7. Logging in and logging out

Who can perform this action: Healthcare Professional, Department Doctor Head, Department Doctor, Independent Practice Doctor, Medicilio Customer Support, Ops.

7.1 Authentication method

Medicilio RPM uses passwordless authentication via one-time password (OTP) sent by email. There is no permanent password to remember.

7.2 Logging in

1. Open the Medicilio RPM web application at the URL provided in your onboarding email.
2. Enter your email address and submit. A 6-digit one-time password is sent to the same email.
3. Enter the OTP within its validity window.
4. The web app loads with the role that has been assigned to your account.

7.2.1 First-time login

On first login, clinicians and medical staff are required to complete a one-time registration process before accessing the application.

1. Review the Terms of Use and Privacy Policy (both available to consult in full). Accept the policies to proceed.

2. The registration form opens. The following fields must be completed:
   • Title, first name, last name
   • Tax identification number (Codice Fiscale)
   • Phone number
   • Specialisation
   • Hospital ID
   • Email, department, and role are pre-filled and cannot be edited.

3. Read and accept the Privacy Policy and the Terms and Conditions set by your organisation.
4. Save the form to complete registration. The application loads with your assigned role.

7.3 Logging out

Open the user menu and select Log out. The session is closed; subsequent navigation requires a new OTP.

7.4 Session management

Sessions expire automatically after a period of inactivity:

• 7 days for clinical and operational users on the web application.

Closing the browser tab or the mobile app does not, by itself, terminate the session, explicit logout is required to terminate the session on demand.

8. Patient onboarding and pathway activation

8.1 Roles in the onboarding flow

8.2 Pathway lifecycle

A pathway is created as a draft, prepared by the Medicilio Customer Support (payment, kit, network), shipped to the patient, then activated by the patient upon receipt. From there it remains active until it is paused (temporarily suspended) or moved to completed at the planned end, or canceled if interrupted early. The system shows the current status as a coloured badge on the pathway header and enforces invalid transitions on the server.

8.3 Creating and managing the patient record

Procedure — View the patient list

Who can perform this action: Department Doctor, Independent Practice Doctor, Department Doctor Head, Healthcare Professional, Medicilio Customer Support, Ops.

1. Open the Patients view from the main sidebar.
2. The patient list is displayed as a table with three columns: Patients and Actions.
3. Use the search field to filter the list; the table updates to show only patients matching the search criteria.
4. Click Visualizza on a patient row to open that patient's detail page.

Procedure — View a patient's care pathways

1. Open the Patient list and select a patient.

2. Select the Pathway tab. The list shows all pathways associated with this patient, each with start date, end date, duration, and status.

3. Click View on the pathway card to open its detail page (see §9).

Procedure — View a patient's details

1. Open Patient list and select a patient from the list.
2. The patient record opens on the Info patient tab, organised into three cards:
   • Patient Information: name, age, gender, address, RSA, phone, email.
   • Caregiver Contact: caregiver name, phone number, relationship to the patient.
   • Health Information: height, weight, pathologies, anamnesis.

Procedure — Update patient health information

1. Inside the Info Patient tab every card has an "Update" button, select the one in the patient health information card.
2. Update the relevant fields (height, weight at enrolment, pathologies and anamnesis).

3. Click Save.

Procedure — Update caregiver's contacts

1. Open the patient record and select caregiver's contacts.
2. Add, edit, or remove contacts as needed.
3. Click Save.
4. The alert service is updated immediately; subsequent red-level alerts will be routed to the new contact list.

Procedure — Create a patient record

Who can perform this action: Department Doctor, Independent Practice Doctor, Department Doctor Head, Healthcare Professional, Medicilio Customer Support, Ops.

1. Open the Patients view from the main sidebar.
2. Click New patient.

3. Enter the identification fields: first name, last name, tax code (Italian codice fiscale), date of birth, gender.

4. Enter the contact details: phone number, email, address.
5. Enter the medical information: weight, height, pathologies and anamnesis. More than one pathology can be selected. The anamnesis is optional.

6. Optionally enter the caregivers block (name, relationship, phone number), which can also be completed later from the patient record. These contacts are the emergency contacts used by the alert service (see §10).

7. Click Save. The patient record is created and is now available for pathway assignment.

8.4 Équipe (care team)

Who can create and edit named équipes: Department Doctor Head, Department Doctor, Independent Practice Doctor, Organization Admin, Medicilio Customer Support, Ops.

Who can add or remove members on a specific pathway: the Responsible Doctor, any member of that patient's équipe, the Department Doctor Head for any pathway in their department, Organization Admin, Medicilio Customer Support, Ops.

An équipe is a named, reusable group of healthcare professionals. A patient's care team is built from one or more équipes, from individually added professionals, or from any combination of the two. The patient is visible to every professional on that team.

Which patients a professional sees depends on their role.

• Department Doctor, Independent Practice Doctor and Healthcare Professional see a patient through an équipe, or through an individual assignment on that pathway.
• Department Doctor Head and Healthcare Professional see every patient in their department. Belonging to an équipe adds patients outside it.

An équipe determines which patients a professional sees. What a professional may do is governed by their platform role, as set out in the "Who can perform this action:" lines throughout this document.

For a Department Doctor Head the two rules differ. Every patient in the department is visible, and every pathway in the department opens in full. Clinical action on a pathway is reserved to the professionals who follow that patient.

A Department Doctor Head follows a patient as Responsible Doctor, through one of the patient's équipes, or through an individual assignment on that pathway. On those pathways they work without restriction.

Every other pathway in the department opens read-only. The Info, Details, Trends, History, Alert Threshold Protocol, Documents and Activity diary tabs are readable in full, and the controls that would change the pathway are not offered.

Read-only covers the whole care plan : alert resolution, threshold updates, patient and health information, network information, devices and shipping, pathway status, pause and cancellation, notes, document upload and report settings.

Two things fall outside that rule, in opposite directions.

• Composing the care team is available on every pathway in the department. The Équipe card, adding and removing professionals, and assigning an équipe are all available. This is the mechanism by which a Department Doctor Head covers a colleague.
• Telemonitoring reports are visible only for the patients the Department Doctor Head follows. The Reports section of any other pathway in the department is empty.

The Patient list shows a Department Doctor Head every patient in the department, and the Alert Threshold Protocol tab of every one of those pathways is readable. Departmental oversight of the thresholds in force is therefore available without joining an équipe.

Two things are reserved to the Responsible Doctor. Only they can sign that patient's telemonitoring report, and they cannot be removed from the pathway. Transferring clinical responsibility requires cancelling and recreating the pathway.

A professional added to an équipe gains access to the patient's complete clinical history, not only to data recorded after they joined.

Organization Admin, Medicilio Customer Support and Ops manage équipe membership without gaining clinical access to the patients concerned.

Once a professional is named on an appointment, they keep it even after being removed from the patient's équipe : the appointment stays assigned and fully manageable, video session included.

For a teleassistenza appointment, the Healthcare Professional offered is the pathway's équipe : its members and any professional added ad hoc to that pathway. Televisit, in-studio and at-home appointments are booked with the pathway's doctor only.

A Department Doctor sees the appointments assigned to them and the appointments of the patients they follow through an équipe. A Department Doctor Head sees, in addition, the appointments of their équipe patients outside the departments they head. A Healthcare Professional sees the appointments of the patients they follow through an équipe or an individual assignment.

An équipe may span departments. The platform derives and displays whether an équipe is single-department or multi-department from its members.

Procedure — Manage named équipes

1. If you are a Department Doctor, open Equipe directly from the main sidebar. Every other role with this permission (Department Doctor Head, Independent Practice Doctor, Organization Admin, Medicilio Customer Support, Ops) opens Admin from the main sidebar and selects the Équipe tab instead. Both open the same équipe list, showing each équipe's name, its members, the department or departments it spans, and the number of patients with an active pathway assigned to it. Closed pathways are excluded from that count.
2. Click New équipe, give it a name, and add at least two professionals.
3. To change an existing équipe, open it, add or remove members, and save.

Procedure — Compose a patient's care team from the pathway

1. Open the patient's pathway and locate the Équipe card on the Info tab.
2. Add an existing équipe as a whole, add individual professionals ad hoc, or create a new named équipe on the spot. An équipe created here is saved and becomes reusable from the Admin page.
3. Individual members of a named équipe can be picked for this patient without altering the équipe itself. The internal composition of a named équipe can only be changed from the Admin page.
4. A patient may be assigned more than one équipe at the same time. There is no limit on members per équipe, or on équipes per patient.
5. To remove a professional, use the remove action on their row. Removal revokes visibility of the patient only. It is never blocked by existing appointments, and it leaves those appointments assigned to the removed professional.

Procedure — Invite a professional who has no account yet

1. From the Admin page équipe editor, or from the pathway's Équipe card, enter the professional's email address.
2. The professional is added immediately and shown as pending, in both the Admin équipe view and the pathway. A pending member has no access to any patient data and receives no alerts: confirm that a member is active before treating them as part of the care team.
3. When that person completes registration, the association activates automatically and their access begins. No notification is sent to the person who invited them.

9. Managing care pathways

9.1 Creating a pathway

Who can perform this action: Department Doctor Head, Department Doctor, Independent Practice Doctor, Medicilio Customer Support, Ops.

Pathways may be created from a pathway template and thresholds template or fully customised. The pathway carries: pathology, duration in months, responsible doctor, list of vital parameters with measurement frequency, a network configuration for the home kit (all mandatory),and a list of associated devices, plus, where applicable, a list of drug intakes, a list of questionnaires, a list of exams (with modality).

Procedure — Create a pathway

The pathway-creation is a four-step process.

1. From the main sidebar, click Pathways. On the resulting page, click Assign pathway.

2. Search for and select the patient. Assign the responsible doctor for the pathway, and compose the patient's équipe: add an existing équipe, add individual professionals, or create a new équipe on the spot (see §8.4). The équipe can also be changed later, from the pathway's Info tab.
3. Select pathway template. Pick a pathway template from the list or create a new one, templates carry the pathology, duration, vital parameters (with frequencies), drug intakes, questionnaires, exams and the default device list.

For each prescribed vital parameter, set the measurement frequency, the recommended time slot, and whether the timing is fixed or flexible:

Time slots are Morning 05:00–12:00, Afternoon 12:00–18:00 and Evening 18:00–24:00, and are shown with their time range everywhere they appear, on both the clinician web application and the patient application. The fixed or flexible choice can also be changed later, when editing the pathway.

Peak expiratory flow, where prescribed, is measured once or twice daily; for a twice-daily frequency, set the morning and the evening measurement time. It cannot be entered manually by the patient, so a missed reading cannot be recovered after the fact. Monitoring of a parameter can be paused and reactivated later from the pathway's Details tab: while it is paused the activity disappears from the patient app, the patient is notified, and no alert is generated for that parameter. Readings already recorded remain in the history.

4. Configure alerts (thresholds). For each vital parameter of the chosen template, configure the yellow- and red-level thresholds. A threshold template can be applied to pre-fill the values, then edited.

5. Summary and submit. Review the full pathway summary (patient, doctor, template, thresholds, vital parameters). Click Submit to create the pathway or go back to make changes (if needed). The responsible doctor (and the patient) receive a confirmation email when a pathway is assigned to them.

After the pathway is submitted, the Medicilio Customer Support takes over the kit-preparation step (devices, network configuration, shipping) from the Info tab of the pathway (see §6.4). The pathway becomes visible to the patient on the tablet only after the kit is shipped and the patient activates the pathway (see §9.10).

9.2 Info tab

Who can perform this action: Healthcare Professional, Department Doctor Head, Department Doctor, Independent Practice Doctor.

The Info tab is the default view when opening a pathway. The header shows the patient's name, age and gender, the assigned doctor (with organization and specialisation), a phone-call shortcut, the date/time of the last measurement received, and the date/time of the last gateway connection (shown as "Data not available" if the gateway has never connected).

The tab is organised into the following cards:

• Patient Info: first name, last name, date of birth, tax code, personal address, RSA status (whether the patient is registered under a residential care facility), phone, email.
• Medical Info: height, weight, pathologies, anamnesis.
• Pathway Status: the current status
• Équipe: the Responsible Doctor and every professional who can see this patient, with pending members marked as such. See §8.4.

Procedure — Edit patient info or medical information

1. Open the pathway and select the Info tab.
2. Click Edit on the Patient Info or Medical Info card.
3. Update the fields and save. A confirmation message is shown once saved.

Procedure — Pause a pathway

1. On the Pathway Status card, click Pause.
2. Confirm in the modal dialog.

3. The pathway moves to paused; all future scheduled activities are removed from the patient's calendar and the subscription is suspended.

Procedure — Cancel a pathway

1. On the Pathway Status card, click Cancel.
2. Confirm the cancellation in the modal dialog.

3. The pathway's status changes to canceled; future activities and future appointments are removed; the gateway identifier is released; device instances are de-assigned; alert recipients and emergency contacts are removed.

Medicilio Customer Support and Ops can cancel a pathway from any status : To be paid, Kit to be shipped, Kit shipped or Active. The pathway moves straight to Cancelled, and none of the intermediate status emails is sent to the patient.

Side-effects summary:

• Paused: future activities are removed from the patient's schedule; the subscription is paused.
• Canceled: future activities and future appointments are removed; the gateway identifier is released; device instances are de-assigned; alert recipients and emergency contacts are removed.
• Completed: same de-assignment of device instances; subscription is cancelled; an end-of-pathway email is sent to the patient.

9.3 Details tab

Who can view this tab: Healthcare Professional, Department Doctor Head, Department Doctor, Independent Practice Doctor.

The Details tab shows the configuration of the care pathway, organised into cards:

Pathway Info: pathway name, duration, start/end date, pathology, goal (free text), assigned doctor and organization.

Parameters to Monitor (mandatory): the vital parameters prescribed in the pathway, each with its monitoring frequency. The list of parameters itself is fixed at pathway creation and cannot be edited afterwards, only the frequency of each already-listed parameter can be changed.

Medications (optional): prescribed drug intakes, each with name, dosage, frequency, and instructions.

Questionnaires (optional): prescribed questionnaires, each with frequency and indicative start date where relevant.

Recommended Exams (optional): recommended exams, each with frequency/modality.

Procedure — Edit pathway details

1. Open the pathway and select the Dettagli tab.
2. Click Edit on the relevant card.
3. Update the fields and save.

9.4 Trends tab

Who can view this tab: Healthcare Professional, Department Doctor Head, Department Doctor, Independent Practice Doctor.

Procedure — View pathway trends

1. Open the pathway and select the Trends tab.
2. Vital-parameter trends are shown as line charts, one per parameter; switch between parameters with the chart toolbar.

3. Select a date range using the selector at the top of the tab (this range applies to all charts on the page, including the compliance chart below). Ranges longer than three months are aggregated weekly rather than daily so that long pathways stay legible; the aggregation is applied automatically and is reflected on the chart axis.

Patient compliance chart

Medicilio RPM calculates a compliance score for each pathway, measuring how consistently the patient completes prescribed activities (measurements, drug intakes, questionnaires).

In the Pathways list:

A column labelled "Compliance" shows the overall compliance percentage for each pathway, as a coloured pill:

• 🟢 Green ≥80% (good adherence)
• 🟡 Yellow 60–79% (moderate adherence : monitor closely)
• 🔴 Red <60% (low adherence : intervention likely needed)

An arrow next to the pill shows the 7-day trend (improving / stable / declining). Click the column header to sort by compliance, highest or lowest first.

At the bottom of the Trends tab, a compliance chart shows how consistently the patient is following the prescribed care plan, with four independently toggleable lines:

• Overall: all prescribed activities combined
• Vitals/Device: device measurements only
• Medications: drug intake
• Questionnaires: questionnaire completion

The Y-axis is fixed between 0% and 100%. Hover over any date to see a tooltip with the values of the currently visible lines. If the patient has not yet completed any activities, a placeholder message is shown instead of an empty chart.

9.5 Appointments tab

Who can perform this action: Healthcare Professional, Department Doctor Head, Department Doctor, Independent Practice Doctor.

The Appuntamenti tab, inside a patient's pathway, shows that patient's appointments only (televisit, teleassistenza, in-studio, and at-home visits). From here you can also schedule a new appointment for this patient directly, without going through the global Appointments page, the patient is pre-selected, so the booking flow starts from selecting the service.

For the full appointment scheduling, joining, updating, and cancellation procedures, see §11. The same procedures apply whether you start from this tab or from the global Appuntamenti page.

9.6 Documents tab

Who can perform this action: Healthcare Professional, Department Doctor Head, Department Doctor, Independent Practice Doctor.

Unlike Appuntamenti, there is no separate global Documents page, the Documents tab inside a patient's pathway is the only place to access this patient's documents. It contains four sub-tabs: Reports, signed teleassistenza reports, Questionnaire Responses, and Shared Documents.

For telemonitoring reports see §12. For signed teleassistenza reports see §11.5, "Write and sign a teleassistenza report".

Questionnaire Responses

The Questionnaire Responses sub-tab lists completed questionnaires, with columns: Name, Description, Type, Questions, Date, and Action. Only answered questionnaires appear, past unanswered and future scheduled questionnaires are not shown. Use the search (by name) or filters (type, date) to narrow the list. Click View to open a questionnaire's responses as a PDF. If no questionnaires have been answered yet, an empty-state message is shown.

Shared Documents

The Shared Documents sub-tab lists contain all the files shared for this pathway: uploaded by clinical staff, by the patient or shared via chat. Each row shows: Name, Owner, Origin (Shared by Patient / Shared by Physician / Chat), Upload Date, and Patient Access status. Documents can be searched by name or owner, and filtered by origin, date, and patient-access status.

Document constraints

Procedure — Upload a document

1. Open the patient pathway and select the Documents tab, then Shared Documents.
2. Click Upload document. Select up to 5 files by drag-and-drop or file picker (PDF, JPEG, PNG only, max 20 MB each; over the limit or unsupported format triggers an immediate error).

3. Before saving, the file name can be edited. It's possible to enable the option "Allow patient access" to make the document visible to the patient in their app. If the option is not enabled, the document remains accessible only to authorised clinicians and staff with permission to view that patient's records.
4. Click Save. Documents appear immediately in the table; if one file in a batch fails, the others still upload, with an error shown only for the failed one.

Procedure — View a document

1. In Shared Documents, click a document row to preview it in the embedded viewer

Procedure — Edit document

Who can perform this action: Healthcare Professional, Department Doctor Head, Department Doctor, Independent Practice Doctor, Medicilio Customer Support, Ops.

1. Open the patient pathway and select the Documents tab → Shared Documents.
2. Edit the editable fields: name and patient access flag (whether the patient can see the document on the tablet).

3. Click Save. The content of the file itself cannot be modified; replace the file by uploading a new version if needed.

9.7 History Tab

Procedure — View pathway measurements

Who can perform this action: Healthcare Professional, Department Doctor Head, Department Doctor, Independent Practice Doctor, Medicilio Customer Support, Ops.

1. Open the pathway and select the History tab.
2. Within the History tab, select the Measurements sub-tab. The table lists one row per date, most recent first, with one column per vital parameter prescribed in the pathway (heart rate, SpO₂, blood pressure, ECG, weight, temperature, step count). If more than one measurement was taken for a parameter on that date, only the latest is shown, with a "Show the other X" link to expand the rest.

3. If a measurement on a given date triggered an alert, the Action column shows a Show Alert button.
4. Click Show alert to open the Alert sub-tab, automatically filtered to that date.

Procedure — View and resolve alerts

1. From the Alert sub-tab (reached via Show alert, or selected directly), the table shows: Date, measurement type, alert value, status (To be solved / Solved), resolution reason, and an action column.
2. For an unresolved alert, click Solve to resolve it (see §10.4 for the full resolution procedure).
3. For an already-resolved alert, click Modify to change the resolution (see §10.5).
4. Multiple alerts can be selected via checkbox and resolved together using Solve(N) at the top right.
5. Remove the date filter (Remove filter) to see all alerts for the pathway, not just the selected date.

The plausibility limits below are the outer boundary of what is physiologically possible, not a statement of clinical normality. They are applied platform-wide, independently of the per-pathway alert thresholds in §9.8.

Where drug intakes are prescribed, the Measurements table also carries a medication-adherence column. Each prescribed intake resolves to one of four states, shown identically in the dashboard, in the patient history and in the care-plan history:

9.8 Alert Threshold Protocol tab

Who can update per-pathway thresholds: Department Doctor Head, Department Doctor, Independent Practice Doctor.

Thresholds are stored per pathway in the alert service, not per template. Each parameter can carry up to two threshold levels, yellow and red, each with one of four threshold types: high, low, weight variation percentage (computed over 1-day, 3-day and 7-day windows), and boolean (presence/absence, e.g. AFib flag on ECG).

Procedure — Edit thresholds on an active pathway

1. Open the pathway and select the Alert threshold protocol tab.

2. Click on Modify to open the edit pop-up. The pop-up shows the thresholds for the vital parameters already configured during pathway creation.

3. For each level (yellow, red), enter the threshold value or values for the appropriate threshold type. The four threshold types are: high (alert if the new value is ≥ the threshold), low (alert if the new value is ≤ the threshold), weight variation percentage (alert if the maximum percentage variation across the 1-day, 3-day and 7-day windows exceeds the threshold), and boolean (alert if the parameter flag is true : e.g. AFib on ECG).
4. Click Save. The new thresholds are applied to the next incoming measurement.

Each parameter is presented as a card carrying the parameter name, an information icon giving the recommended clinical range and an explanation of how that parameter's thresholds work, a colour-coded scale bar, and the editable threshold fields. Each field shows its comparator (≤ or ≥) on the left and its unit on the right, and the standard adult normal range appears between the fields as non-editable reference text.

The scale bar follows the direction in which the parameter can breach: blood pressure and heart rate are bidirectional, oxygen saturation and peak expiratory flow breach on the low side, body temperature and weight variation on the high side. The bar is informational: it does not affect how alerts are evaluated.

The ECG card is titled Atrial fibrillation. It carries a single red-level toggle, labelled "Present" when enabled, with no threshold fields and no yellow level.

Entering a value outside the recommended clinical range for a parameter highlights the field and shows a warning naming the range that was exceeded. The warning does not block saving.

Saving is blocked in one case only: when the yellow and red levels of a parameter are ordered inconsistently, for example a red maximum lower than the yellow maximum, because the resulting alert logic would be incoherent. An inline validation message is shown on the field until the ordering is corrected.

Peak expiratory flow is not evaluated against a fixed value but against the patient's own recent readings. An alert is raised on a progressive drop across two or more consecutive measurements within the last seven days, or on a reading markedly below the seven-day rolling median. A manoeuvre with a forced expiratory time below three seconds is technically invalid: no value is produced and the patient is asked to repeat the measurement.

9.9 Activity diary tab

Who can manage pathway notes: Healthcare Professional, Department Doctor Head, Department Doctor, Independent Practice Doctor, Medicilio Customer Support, Ops.

The Activity Diary tab shows both manually added notes and the history of resolved alerts (with resolution reason and status) in a single chronological view, see §10.5 for the alert-resolution history detail.

Procedure — Add a note to a pathway

1. Open the pathway and select the Activity diary tab.
2. Click Create note.
3. Select a category from the available options. The list includes an Alert category, for notes recording the clinical reasoning behind an alert and its handling. Notes in this category are visually identifiable in the diary and can be filtered like any other category.

4. Write or dictate the description. Optionally, attach a file. Click Create note.

The note is timestamped with the author and is visible to all clinical-workflow roles assigned to the pathway.

Procedure — Edit or delete a note

From the Activity diary tab, click the three dots next to the note. Choose Edit note to amend the content, or Delete to remove the note.

9.10 Kit shipping and pathway activation

After a pathway is submitted, the Medicilio Customer Support and Ops team handle kit preparation on the pathway's Info tab: binding the measurement devices, configuring the home gateway and tablet, and arranging shipping. Clinicians have read-only visibility into this information (see §6.4) but do not perform these steps themselves.

The pathway status progresses automatically through this process: once payment is confirmed, it moves to Kit to be shipped; once the kit is physically shipped and configured, Medicilio Customer Support/Ops advance it to Kit shipped.

Procedure — Activate the pathway

The pathway can be activated in two ways:

• Manually: open the pathway, change the status from Kit shipped to Active, and click Save.
• Automatically: when the patient logs into the patient app for the first time using the assigned tablet, the pathway status is set to Active automatically : no manual intervention is required.

In both cases, once the status is Active the care plan monitoring begins and the patient's data starts being collected.

Who can perform this action: Patient (the patient activates upon kit receipt). The action may also be performed on behalf of the patient by Department Doctor, Department Doctor Head, Independent Practice Doctor, Medicilio Customer Support, Ops, Organization Admin.

1. The patient receives the home kit at the address on the patient anagraphics.
2. The patient opens the Medicilio app and the pathway is automatically moved to Active state.

9.11 Pathway, threshold and questionnaire templates

Who can manage pathway templates and threshold templates: Department Doctor Head, Independent Practice Doctor (for own practice), Medicilio Customer Support, Ops.

Procedure — Create a threshold template

1. From the main sidebar, Admin, then open the tab Templates and go to Thresholds subtab.

2. Click New thresholds' template, give it a name, and select the vital parameters covered.
3. For each parameter set the yellow and red threshold values per threshold type (see §9.8).

4. Click Save.

Procedure — Modify a threshold template

1. From the main sidebar, Admin, then open the tab Templates and go to Thresholds subtab, click View template on the template to edit.

2. Update the yellow and/or red threshold values as needed.

3. Click Save.

Procedure — Delete a threshold template

1. From the main sidebar, Admin, then open the tab Templates and go to Thresholds subtab
2. Click on the three dots near the View template and click on Delete template.

3. Confirm in the modal.

Procedure — Create or update a pathway template

1. From the sidebar, Admin then open the tab Templates → Care protocol.
2. Click New protocol.

3. Configure the pathology, default duration, vital parameters, drug intakes, questionnaires, exams and device list (see §9.1 and §9.3).

4. Click Save.

10. Alerts and clinical alarms

This section explains alert meaning, alert lifecycle, and the user responses required by role.

10.1 Alert levels

Two alert levels are defined.

10.2 Alert lifecycle (red-level)

In the clinician interface every red-level alert is shown as either pending (open, awaiting clinical action) or resolved (closed). Internal escalation states (re-measurement requested, escalation to emergency contacts) happen automatically in the background per §10.7 and are not surfaced as separate user states.

10.3 Who can act on alerts

10.4 Required user response

Procedure — Resolve a pending alert

1. From the Dashboard, click the Alert tab. The default filter shows pending alerts across the alert-recipient's pathways. Multiple alerts can be selected via checkbox and resolved together in a single action, without opening each one individually : see the tip at the end of this procedure.

2. Click an alert row to open the alert detail panel. The detail shows the measurement that triggered the alert, the breached threshold(s), the pathway, the patient identification, and the recent history of the affected vital parameter.

3. Review the context. If a contact with the patient is needed, use the registered phone number or the in-app chat.
4. Click Resolve to open the resolution form. Select a Resolution reason from the dropdown : one of "Device error", "Resolved by doctor", "Called urgent care"(the patient or caregiver contacted emergency services : not the clinician), "Patient error", "Not the patient", or "Other".

5. Optionally add a free-text note explaining the clinical decision. To record fuller clinical reasoning, use the secondary "Add note to diary" action on this page: it opens the patient's Activity diary without resolving the alert and without discarding what you have already entered in the resolution form (see §9.9).
6. Optionally send a chat message to the patient as part of the resolution (the Send a message to the patient option appears when chat is enabled for the patient's pathway and the user is authorised to message in that channel).
7. Click Confirm. The alert status moves to resolved; any pending Medicilio Customer Support or emergency-contact notifications are cancelled; the resolution reason and the note are recorded against the alert.

Procedure — View past alerts

1. Open the patient's care plan and navigate to the Activity Diary.
2. Apply the Resolved alerts filter to display only closed alerts.
3. The list shows, for each resolved alert:
   • Name of the clinician who resolved it
   • Date and time of resolution
   • Resolution reason selected
   • Follow-up action taken (if any)
4. To edit a resolved alert, click the ⋮ (three-dot) menu on the corresponding row. This reopens the resolution form pre-filled with the previously saved resolution reason and actions taken : the only two fields that can be modified. Update the values and click Save, or Cancel to discard the changes and keep the previous version.

Procedure — View past alerts

5. Open the patient's care plan and navigate to the Activity Diary.
6. Apply the Resolved alerts filter to display only closed alerts.
7. The list shows, for each resolved alert:
   • Name of the clinician who resolved it
   • Date and time of resolution
   • Resolution reason selected
   • Follow-up action taken (if any)
8. To edit a resolved alert, click the ⋮ (three-dot) menu on the corresponding row. This reopens the resolution form pre-filled with the previously saved resolution reason and actions taken : the only two fields that can be modified. Update the values and click Save, or Cancel to discard the changes and keep the previous version.

Procedure — Manage Caregivers contacts for a pathway

The emergency contacts used by the alert service are those recorded in the patient record (see §8.3). The alert recipient binding is created automatically when a pathway transitions to active, and removed when the pathway is cancelled or completed. To inspect or update the binding:

1. Open the Patient list and click Edit on the Caregiver Contact card.
2. A pop-up window opens with the following editable fields:
   • First name, last name
   • Relationship
   • Phone number
3. Save the form. The updated details will be reflected in all the alert details.

10.6 Notification delays

When a red-level alert is triggered, the Medicilio Customer Support and the emergency contact are notified automatically. Notification delays are platform-wide constants and apply uniformly to every red-level alert across all organisations and pathways.

11. Appointments and video consultations

Who can create, update or cancel appointments: Healthcare Professional, Department Doctor Head, Department Doctor, Independent Practice Doctor, Medicilio Customer Support, Ops, Tech (per permissions list). Who can perform at-home appointment dispatch: Medicilio Customer Support, Ops.

11.1 Appointment statuses

11.2 Appointment durations and types

Durations: 30, 45 or 60 minutes.

Two appointment types require a video session:

• televisit : a remote consultation between the clinician and the patient.
• teleassistance : a remote support session, typically operated by a Healthcare Professional.

11.3 Scheduling an appointment

1. Open Appuntamenti from the main sidebar. The page shows three tabs: Scheduled, To be scheduled, and History.
2. Click New appointment. A form opens with the following fields.

3. Select the patient and the service.
4. Select the delivery method : the available options depend on the service selected in the previous step: televisit, teleassistance, in-studio visit, or at-home visit.
5. For televisit, teleassistance, and in-studio visits: select the healthcare professional who will conduct the appointment : the list of assignable professionals updates based on the service and delivery method selected, showing name and specialisation. For teleassistenza, this list is the patient's équipe (§8.4). Then pick the duration (30 / 45 / 60 minutes) and a time slot; the slot picker filters by the selected professional's availability and the chosen duration. For at-home visits: the professional, duration, and time slot are not selected at booking.

6. Add any optional notes for the patient or the clinician (text or voice dictation).
7. Click Save. The appointment is created in scheduled status and appears in the Scheduled tab. Both the patient (and caregiver, where applicable) and the assigned healthcare professional receive a confirmation notification.

A patient's appointments (televisit, teleassistance, at-home, and in-studio) are also listed, in the Appointments tab of their pathway : useful when reviewing a specific patient's schedule without going through the global Appuntamenti page.

11.4 Joining a video session

Video sessions are conducted through the integrated telemedicine module. No clinical data is transmitted to the video provider. Televisit and teleassistance sessions follow the same underlying video technology, but differ in who can join: only the assigned Department Doctor can join a televisit, while either the assigned Department Doctor or Healthcare Professional can join a teleassistance.

Procedure — Clinician joins a televisit or teleassistenza

1. Open Appointments from the sidebar (or the Appointments tab in the patient's pathway). The Open button for an appointment is disabled until the day of the appointment; it is never active before the scheduled day.

2. On the day of the appointment, click Open. The appointment screen displays:

• Date, time, and visit type,
• Patient and caregiver details (phone number, email, and chat access),
• Info & Documents panel: medical information, care plan details, uploaded documents, and reports,
• Quick actions: view the patient's related appointments, manage or delete the appointment. Click Partecipate (top right) to proceed to the pre-session screen. This option is enabled only for the healthcare professional assigned to the session, starting 15 minutes before the scheduled time.

3. Grant the browser permission to use the camera and microphone (this is requested only on the first session per browser). On the pre-session screen, configure your devices:

• Camera input
• Microphone input
• Default audio output

A live camera preview is shown. Click Connect to enter the session.

4. Wait for the patient to join. The patient sees a corresponding Join button on the tablet at the scheduled time. The video session opens. The screen shows the patient's camera feed with your own feed below. Available controls during the session:

• Enable / disable your camera
• Enable / disable your microphone
• Share your screen
• Open the in-session chat (for messages and documents)
• Exit (red button) to end the call
• Share – share documents with the clinician during the session.

5. Clicking Exit opens a confirmation prompt. Select End televisit to end the session and return to the Appointments list, or dismiss to remain in the call.

If you close the session after the patient has joined, the appointment is marked completed. If the patient never joined, it is marked not conducted, and the appointment must be rescheduled. If either participant loses connection, they can rejoin within the same waiting-room flow as long as the appointment is still within its scheduled window; if the professional does not return within 10 minutes, or both participants remain disconnected for more than 10 minutes, the session ends automatically.

11.5 Updating, cancelling and signing an appointment

Procedure — Update an appointment

Who can perform this action: Healthcare Professional, Department Doctor Head, Department Doctor, Independent Practice Doctor, Medicilio Customer Support, Ops.

1. Open the appointment from the appointment list or the patient record and click the three-dot menu (⋮) on the right side of the appointment row.
2. Click Manage. The appointment details screen opens with all fields pre-filled and editable.

3. Change the date/time, the duration, the assigned clinician, or the notes. The appointment cannot be moved to a slot already taken.
4. Click Save. Both the patient and the assigned professional receive an email notification.

Procedure — Cancel an appointment

1. Delete the appointment either:

• directly from the Appointments list, by opening the three-dot menu next to the appointment row and clicking Elimina; or
• clicking Open to enter in the appointment detail page, then selecting Delete from the Quick actions section.

2. A confirmation modal appears. Select a cancellation reason from the dropdown (e.g. Professional Not Available, Patient Not Available, Care Plan Change/Suspension, Exam Not Necessary), or choose Other to enter a free-text reason manually or by dictation.

3. Click "Delete Appointment". The appointment is cancelled and moves to the Past appointments section, where it remains visible with the status Cancelled and the reason provided.
4. The patient receives an email notification of the cancellation.

Procedure — Write and sign a teleassistenza report

Who can perform this action: the Department Doctor or Healthcare Professional assigned to the completed teleassistenza (report writing is available only for teleassistenza, not for televisit : see §11.4)

1. Open the completed teleassistenza appointment, or go to Appointments→ History and find the appointment. Click Write Report. This action is available only once the appointment status is Completed and both the patient and the professional were present during the session.

2. Step 1 : Write: enter the report content manually in the text editor, or use voice dictation as an alternative. If you try to leave the page with unsaved content, a confirmation modal warns that changes will be lost.

3. Step 2 : Attach documents (optional): upload supporting files (PDF or image). These are linked only to the report, not stored in the patient's general document archive. You can go back to Step 1 without losing what you wrote.

4. Step 3 : Preview & sign: review the final report preview. Click Sign to start the electronic signature flow.

5. Once signed, the report becomes read-only. It is available in two places: the patient's pathway under Reports, and in Appointments → History, where the action changes from "Write Report" to Show Report (opens the signed PDF in a new tab). The signed report is also visible to the patient under the Documents section in the patient menu on the tablet.

11.6 In-studio and at-home visits

Procedure — Schedule an in-studio visit

1. In Appointments, click New appointment. Select the patient and the service.
2. Select in-studio visit as the delivery method.
3. Select the assigned healthcare professional, pick a duration and time slot, and confirm.
4. The Update status action (available once the visit's day arrives) is used to mark the visit as completed or not.

Procedure — Schedule an at-home appointment

1. In Appointments, click New appointment. Select the patient, the service, and At-home appointment as the delivery method.
2. No specific professional, duration, or time slot is selected at booking.
3. The patient and the dispatched clinician receive notifications; the address shown in the patient record is used.

Procedure — Cancel an in-studio visit/at-home appointment

1. Open the appointment.
2. Click Cancel. Provide a reason.
3. The appointment is closed; the patient and the clinician (for the in-studio visit) are notified.

12. Telemonitoring reports

12.1 Report frequencies

Telemonitoring reports can be configured at frequencies: weekly, biweekly, monthly, quarterly, final, or custom.

12.2 Three-state report lifecycle

Each report goes through three stages:

Once signed, the report records the signature timestamp and tracks whether the patient has opened it. The report is created through a three-step process: configure settings → review and edit the AI draft → review the final PDF and sign.

Step 1: configure settings and generate

1. Open the patient record and select the Reports tab. Click New report.

2. Choose the patient and the frequency (weekly, biweekly, monthly, quarterly, final, custom) and if you set the custom one confirm the period (start and end dates). This screen also lets you preview / adjust the list of sections that will be drafted and the vital parameters included. (see §12.4, 'Configure telemonitoring report settings', for how to change the default frequency at organization or pathway level).

3. Click Generate content. The report enters generating status; the AI component drafts each section in turn. The system advances automatically to step 2 when generation is complete.

Step 2: review and edit the AI-drafted content

The report creation screen shows the report as a list of editable sections (one card per section). Only sections relevant to the patient's pathway are included : for example, if the patient has no prescribed medications, the Medication section does not appear. Categories that are not part of the care plan are omitted rather than described as missing data. Where drug intakes or questionnaires are prescribed, the "Terapia e Aderenza" section carries the patient's compliance chart for the report period (see §9.4). Where peak expiratory flow is prescribed, a dedicated section carries its trend chart.

1. For each section, review the AI text and edit as needed. A disclaimer under the report period states that the content is AI-generated from the patient's clinical data and that the clinician is responsible for verifying its correctness before validation.
2. Only the Doctor (Department Doctor Head, Department Doctor, Independent Practice Doctor) can edit the section content and proceed to sign the report. A user without signing permission cannot enter the signing flow or edit the report text: the action is hidden or disabled from the outset. Other roles authorised to generate a report can view the draft.

3. Click See preview to proceed to the PDF preview step.

Step 3: review the final PDF and sign

1. The report creation screen shows the final PDF preview rendered from the edited section contents.
2. Review the document end-to-end. If a change is needed, go back to step 2.

3. Click Sign to apply the electronic signature. The report status moves to sent; the patient sees the report on the tablet from this point on.

All reports for a patient, signed and unsigned, are listed together in the pathway's Reports tab (see §12.4, "Download a report"). The list shows each report's name, creation date, period, status, and owner (the clinician who created/signed it). Reports in Sent status can be downloaded; reports in To review status can be opened for review and signature with the Review action, which opens the section editor directly at step 2 rather than restarting the generation flow.

12.3 Who can perform each action

Who can generate a telemonitoring report: Department Doctor Head, Department Doctor, Independent Practice Doctor, Medicilio Customer Support, Ops.

Who can review and edit the AI draft of the Pathway Report: Department Doctor Head, Department Doctor, Independent Practice Doctor.

Who can sign a telemonitoring report: Department Doctor Head, Department Doctor, Independent Practice Doctor.

Who can submit feedback on a generated report: Department Doctor Head, Department Doctor, Independent Practice Doctor.

For a Department Doctor Head every report action applies to the patients they follow, per §8.4. The Reports section of any other pathway in the department is empty.

12.4 Managing the report list (download, history, feedback, delete)

Procedure — Download a report

1. Open the patient pathway and select the Reports inside the Documents tab.
2. The list shows all reports with status badges (to review / sent).

3. Click the download icon on a sent report to obtain the signed PDF.

Procedure — Provide feedback on a generated report section

While reviewing a report (see §12.2), the clinician can mark individual sections of the AI draft as good or in need of improvement.

1. Open the report in "to review" status.
2. For each section, click the thumbs-up or thumbs-down icon next to the section heading.

The feedback is stored against the report version and is used by Medicilio to monitor and improve AI quality.

Procedure — Delete a report

Who can perform this action: Healthcare Professional, Department Doctor Head, Department Doctor, Independent Practice Doctor, Medicilio Customer Support, Ops.

1. Open the Reports list.
2. Only reports in "To review" status (reports not yet signed) can be deleted. Click the action menu next to the report and choose Delete. Confirm in the modal.

3. The deleted report is no longer visible in the list.

Procedure — Configure telemonitoring report settings

Who can update the telemonitoring report settings: Department Doctor Head, Department Doctor, Independent Practice Doctor, Medicilio Customer Support, Medicilio Sales Team, Ops.

1. From the patient pathway in Reports tab inside the Documents, open Settings.
2. Configure the report frequency (weekly, biweekly, monthly, every 3 months, or final).
3. Select which report sections to include or exclude (e.g. vital parameters, questionnaires, therapy and adherence, clinical contacts, summary, alert information). Excluded sections are listed in the settings summary after saving.
4. Configure any applicable preferences.

5. Click Save. The settings apply to subsequent generated reports for this specific patient; previously generated reports are not modified. When a clinician generates a new telemonitoring report for a patient, the AI component drafts the report content based on the settings currently saved for that patient's pathway.

12.5 Appointment reports

Reports produced after a televisit or teleassistance appointment are stored separately as Appointment Report, signed electronically, and are visible to the patient only after signature.

12.6 Organization analytics

Who can perform this action: Organization Admin.

An Analytics entry appears in the main navigation for Organization Admins, and is the page shown on login. It reports the organisation's activity in aggregate across every department and doctor. No other role can reach the page, and it contains no individual patient data.

The page opens on the last 30 days. Other presets and a custom date range are available, and the selected period drives every widget on the page at once. It reports:

• headline figures for total patients, active pathways, average pathway duration, and doctors enabled on the platform;
• active patients over time, and active patients by department;
• registered patients against patients actually taken into care;
• pathways by status, and the duration distribution of completed pathways;
• clinical alerts generated, resolved and still open, each attributed to the period in which the alert was generated rather than resolved;
• adherence over time across the organisation's patients;
• doctor coverage, and a per-doctor table of patients, active pathways, average duration and average patient adherence, with search, department filter and column sorting.

Each figure is shown against the equivalent immediately preceding period. Where the organisation has no history covering that baseline, the comparison is suppressed rather than presented as growth.

13 In-app chat

Two chat channels exist in the patient app.

Procedure — Read and reply to a chat message

1. Open the patient record and select the Chat tab. Unread messages are shown in bold with the channel badge.
2. Open the relevant channel and read the latest messages.

3. Type the reply and click Send. The patient receives an in-app notification on the tablet.

14. IT security and data protection

14.1 Hosting and data residency

Medicilio RPM is hosted on Google Cloud Platform in the EU region (Belgium, Frankfurt and Milan). All clinical data and personal data are stored in the EU. Databases and their backups are held in the regions named above. Object storage, which holds archived application logs, uses Google Cloud EU multi-region storage and may therefore hold data in any European Union member state.

14.2 Personal data and GDPR

Personal data is processed in accordance with Regulation (EU) 2016/679 (GDPR) and Italian Legislative Decree 196/2003 as amended. The Data Controller is the healthcare provider organisation that prescribes the pathway; Cantieri Digitali Medtech S.r.l. acts as Data Processor.

14.3 Transport and at-rest protections

• All client-server traffic uses HTTPS / TLS.
• Database storage uses Google Cloud-managed encryption at rest.
• Documents are stored in Google Cloud Storage; download URLs are signed and valid for one hour.

Medicilio's information-security controls follow the principles of confidentiality, integrity and availability appropriate to a Class IIa MDSW under MDR §23.4(ab) and MDCG 2019-16. This Instructions for Use does not cite specific information-security management standards; the underlying organisational controls are documented in Medicilio's internal Quality Management System.

15. Cybersecurity for users

15.1 Account

• Each user has a personal account tied to a single email address.
• Authentication is passwordless : a one-time password is sent to the registered email at every login.
• One-time passwords are single-use and expire shortly after they are generated. Sharing an OTP with another person grants that person access to the account.
• Sessions expire after a period of inactivity (see §7.4).

15.2 What to do if your account is compromised

If you suspect that an unauthorised person has access to your Medicilio account or to the email inbox associated with it:

1. Stop using the device for any clinical action.
2. Notify Medicilio support at the email and phone numbers in §2.2, providing the email address associated with the account and a brief description of the suspected compromise.
3. Medicilio support revokes the affected email from the Kinde identity provider back office, which terminates the user's ability to authenticate. Any active session is invalidated at the next token refresh, and no further one-time password can be issued for that email until the account is re-provisioned.
4. The user must be re-provisioned by an authorised role before regaining access (see §7 : provisioning).
5. The data controller documents the suspected compromise in line with its incident-response procedure (GDPR Article 33 / 34 where applicable).

16. Maintenance and software updates

16.1 Software updates

Medicilio RPM is delivered as cloud software (back end) and as two client applications (web and mobile). The release cadence is approximately one release every three months; security and hotfix releases may be issued more often. User-notification mechanism for updates is TBD

16.2 Data backup

Patient and pathway data are backed up by the manufacturer as part of the cloud back-end operation. Users do not need to perform local backups.

16.3 Account recovery

See §15.2.

17. Troubleshooting

The table below covers the most common user-facing failure modes.

18. Reporting of serious incidents

Any serious incident that occurs in relation to Medicilio RPM must be reported to:

• The manufacturer: Cantieri Digitali Medtech S.r.l., at the vigilance email info@medicilio.it
• The Italian competent authority: Ministero della Salute, Direzione Generale dei dispositivi medici e del servizio farmaceutico, Ufficio 5 Dispositivovigilanza. Reports may be submitted through the Banca dati dei dispositivi medici (vigilance section) operated by the Ministero della Salute.

A "serious incident" is defined in Article 2(65) of MDR 2017/745 as an incident that, directly or indirectly, led, might have led or might lead to: the death of a patient, user or other person; the serious deterioration of a person's state of health; or a serious public-health threat.

19. End-of-use, account deletion and data retention

19.1 Ending pathway use

When a pathway reaches its planned end, it is marked as Completed. If it needs to be ended early, it is marked as Cancelled. In both cases, any future scheduled activities are removed and the associated devices are released from the patient's record.

19.2 Patient and account deletion

Who can delete a patient record: Department Doctor Head, Independent Practice Doctor, Medicilio Customer Support, Ops.

When a patient record is deleted, the following sequence is applied:

1. Personally identifying information (PII) : name, surname, tax code, date of birth, address, contact details, emergency contacts, is exported to a sealed audit-only store maintained by Medicilio under documented data-protection controls.
2. The operational patient record is then removed from the application; PII is no longer accessible through the Medicilio RPM user interface to any role.
3. Clinical and billing data that must be retained for the periods set out in §19.3 are kept in their respective retention stores in scrubbed form, i.e. without PII linkage. so that data retention obligations can be met without continued processing of the patient's identity.

19.3 Data retention

Clinical data linked to a pathway are retained for 10 years from the end of the pathway, in accordance with the applicable Italian SSN rules on healthcare records and with the GDPR principle of storage limitation. At the expiry of the retention period, retained clinical data are deleted or further anonymised so that they can no longer be attributed to an identified or identifiable patient.

20. Glossary

21. Manual versions