Class IIa medical deviceCE 3022Hosted by STACKIT in GermanyMore on security

What you want to know about DocPad.

60 answers on the product, introduction, data protection and working together. If you cannot find your question, write to us.

PI Health

What does PI Health do?

PI Health develops software for the point of care. Our product is DocPad, an iPad application that doctors use to capture a patient's condition in structured form during the examination. This capture produces the final report, which is automatically sent back to the practice management system when the visit is completed. We are not a consultancy, but the manufacturer of a certified medical device.

What is DocPad in one sentence?

DocPad is the structured capture layer in front of the practice management system: same work in the consulting room, different result in the record. You capture findings using defined parameters instead of free text and see the patient's condition as a picture across twelve body systems. The practice management system stays where it is.

What about patient consent?

The patient signs their consent with a finger on the iPad. We are happy to explain in person what it covers in detail.

Who is DocPad for?

For doctors at all levels of care and for assisting professions. The intended purpose covers outpatient care, inpatient stays and inpatient emergency medicine, without restriction to any specialty. A facility with a connected practice management system or hospital information system, an iPad released for use and a stable network are required.

Why a separate application and not a module for an existing practice management system?

Because the problem lies before the record, not in it. A practice management system manages what is entered. If free text is entered, it manages free text. We start where the finding is made and make sure it is coded from the outset, according to SNOMED CT, ICD-10-GM and LOINC. This quality cannot be created afterwards.

What sets DocPad apart from dictation and transcription solutions?

Dictation solutions convert speech into text. The end result is free text again. DocPad produces structured, coded data that can be analysed, compared and reused.

Is DocPad a certified medical device?

Yes. Since May 2026, DocPad has been a Class IIa medical device under the MDR. The notified body is Scarlet NB B.V. in Amsterdam, identification number 3022. The certified version is base version 0.5.0.

Since when has DocPad existed?

Development began in October 2021. DocPad has been certified as a medical device since May 2026 and has been in pilot use since then.

Does DocPad come from medicine or from technology?

From both, and the medical side leads. The medical knowledge model, meaning diagnoses, symptoms, findings and how they are linked, is signed off by our Chief Medical Officer Dr. med. Michael Specht in exchange with colleagues, not by developers. That is why new medicine can enter the product without the application having to be rebuilt.

What DocPad does

What exactly does DocPad do during the examination?

You capture the finding using predefined parameters, sub-parameters, attributes and locations instead of free text. Filters hide what is not relevant at the moment, a search bar finds the right entry, and the severity can be set for each body system. Everything you capture is already coded in the background.

What is the Round Tree?

The Round Tree shows the patient's condition across twelve body systems at a glance. Vital signs, severity, symptoms and findings appear as deflections, and unremarkable systems stay green. Instead of reading paragraphs of free text, you see the whole person in one picture.

Does DocPad replace my practice management system?

No. DocPad sits in front of it. The master data comes from the practice management system, structured data capture takes place in DocPad, and the final report goes back. Your billing and administration workflow stays unchanged.

What is an episode, and what is a Snapshot?

An episode bundles one treatment case and can contain several Snapshots. A Snapshot is a single, signed observation, for example one contact with the patient. Only the person who created the Snapshot can edit it, and only within the configured time window. After that, it has to be signed again. This way it is always clear who documented what and when.

How does DocPad support the diagnostic process?

DocPad accompanies the diagnostic process. Symptoms and findings are captured in structured form and assigned to the twelve body systems. This lets you see connections across the whole history, including findings that are not related to today's visit. DocPad does not automatically create diagnoses. The diagnosis is and remains the doctor's decision. This support of the diagnostic process is the reason why DocPad is certified as a Class IIa medical device.

What does DocPad explicitly not do?

DocPad does not automatically create diagnoses. The diagnosis is and remains your decision, as does the therapy. It makes no claim to completeness of the medical content. The model is a reviewed subset. It is not the sole source of critical patient data, and your facility still needs contingency planning. And it does not explain anything to the patient.

Does DocPad work with artificial intelligence?

The certified version works with a medical knowledge model maintained by doctors and with fixed rules, not with a learning model.

Introduction

What do we need to get started?

A connected practice management system or hospital information system, one validated iPad per clinician and a stable, encrypted network in the facility. Plus the training, which is mandatory before clinical use.

Which devices are supported?

DocPad has been developed, tested and validated for the fifth-generation iPad Air and the iPad Air with M2 and M3, each 11 inches. On other devices the interface may look functional and still be incomplete, for example because of shifted layouts that hide safety-critical notices. Please use validated devices only.

How does the introduction work?

In three steps: technical connection to your system, setup of users and departments, training of clinicians.

Do I need training?

Yes, training is mandatory before clinical use. The reason is the principle of episode and Snapshot. If you do not know when a Snapshot is signed and when an episode is closed, you block your own workflow. A basic training session takes about 60 minutes.

Can we test with one doctor first?

Yes. We actually recommend starting small and only expanding once the workflow is established. The only important thing is that the connection to your practice management system is in place from the start.

Who sets up users and departments?

Your facility does, via the Local Admin. This is where user accounts, facilities and departments are managed. Your organisation keeps control over access rights.

We are an MVZ and would like to test DocPad. How does that start?

With a conversation of about thirty minutes, in which we understand your workflow and you see DocPad live. After that, we check the connection to your practice management system together. If both fit, training and a trial installation follow before DocPad goes live at your site.

Daily use and operation

Does this make data capture take longer?

The aim is that the history taking you do anyway becomes structured and reusable without taking longer. The report is generated from the data capture and does not need any reworking at the end.

Do I have to enter everything twice?

No. The master data comes from the practice management system, structured data capture takes place in DocPad, and the final report goes back automatically. Manual transfer is not intended.

Do I have to press a button for the report to arrive?

You confirm the completion of the episode. With this confirmation, the report is handed over. There is no separate export.

What happens if I forget to close the episode?

The report is not transferred, and the patient cannot be given a new episode. The open episode blocks the further workflow until it is closed. That is why closing episodes is on our weekly checklist.

Can I create a patient who is not in the practice management system?

No. The patient must be registered there. In addition, the patient must have statutory health insurance, their health insurance number must be available, and they must have consented to treatment with DocPad.

Can the patient or colleagues see my internal notes?

Communication notes do not leave DocPad and are not part of the report to the practice management system. They can be viewed by doctors who have access to this patient.

Can an assistant prepare the documentation and I countersign it?

Yes, this is provided for as a process. There is a lead physician and a supervisor. If an assistant signs, the episode automatically goes for countersignature and only closes after that. Open cases are sorted to the top for you.

What if the health insurance card has not been read for more than 90 days?

You can access the record for 24 hours by giving a reason. The connection to the practice management system is not affected.

Connecting to your system

How is DocPad connected to our system?

Via a generic connector based on HL7 FHIR, which we operate together with RED Medical. So we do not build a separate connection for each vendor. We connect once and reach many systems through it.

What does our IT have to do?

Grant access to the practice management system, check the Wi-Fi and run the iPads isolated within the network. The network must be encrypted with at least WPA2. Public or unencrypted networks are excluded. We take care of everything else together with your system vendor.

How does the report get back?

With your confirmation that the episode is complete. The report is generated from the structured data capture. There is no second round of writing and no manual export.

Does this also work in a hospital with a HIS?

Yes, the same connector also addresses hospital information systems. In a hospital, getting there usually takes longer because IT and data protection have their own review steps. We bring the documents needed for this.

Data protection and security

Where is patient data stored?

Centrally in the DocPad system, not on the iPad. DocPad is hosted in the STACKIT cloud in Germany. If the app is deleted from the device, the patient data is not affected.

Who can see the data?

Only authorised users of your own facility. Access rights are assigned in the facility's Local Admin. Internal communication notes stay in DocPad and are not part of the report to the practice management system.

Is patient data used to train models?

No. The facility's data is used for treatment and documentation.

What happens if an iPad is lost?

No patient data is stored on the device itself. Even so, change your own password immediately and ask the DocPad team to lock the user account. The devices are operated locked with a passcode and biometric identification.

Do we need a data processing agreement?

Yes. The agreement under Article 28 GDPR is concluded before going live and is already prepared.

Can we use the iPad for other things too?

No. Apart from DocPad and the iOS apps supplied with the device, no other applications should run on it. If the factory settings are kept, system-side assistance services such as voice input stay deactivated. Such services can be connected to external providers.

What are the requirements for the Wi-Fi?

Four rules. No public or unencrypted networks. Only your own facility's network. At least WPA2. And run the device isolated within the local network. An unstable connection can cause delays in transmission.

What do we do if we suspect a security incident?

If the device behaves unusually, does not respond or is noticeably slow, take it out of clinical use and report the incident to security@docpad.cloud. We will agree the next steps with you.

Regulation and liability

What does Class IIa mean for me as a user?

It means that DocPad has not only been declared by the manufacturer itself but has been assessed by an independent notified body: intended purpose, clinical evaluation, risk management, software life cycle, IT security and usability.

Who is liable for the documentation?

Responsibility for diagnosis, therapy and the accuracy of the documentation remains with the treating physician. As the manufacturer, we are responsible for ensuring that the product does what is stated in the intended purpose and that it meets the requirements of the MDR in doing so. The signature on the Snapshot records who documented what and when.

Does DocPad replace the doctor's assessment?

No, and it is not meant to. It supports the assessment by making the clinical picture more complete. The outputs are based exclusively on the data entered. Overreliance, especially with little experience or under time pressure, can lead to wrong decisions. This is also stated in our instructions for use.

What happens during an update?

Updates belong in off-hours, never during consultation hours. New iOS versions and device models are first tested on a spare device, and all devices are never updated at the same time before compatibility is confirmed. After each update, briefly check that everything works.

How often does the product change?

The medical knowledge model is versioned content, not program code. Content is never deleted but marked as outdated. Major product versions each go through a procedure with the notified body.

Collaboration

What forms of collaboration are there?

Four. Use as a user in a practice, MVZ or hospital. Taking part in the pilot with close support and joint measurement. Technical partnership, if you want to build your own medical modules on DocPad. And collaboration with payers and associations on care models.

We are a health insurer or payer. What would we gain?

Structured, coded treatment data from routine care instead of free text. This is the prerequisite for quality reports and health services research. For selective and care contracts, we are happy to talk about a joint model.

We are developing our own medical application. Can we build on DocPad?

Yes, this is explicitly intended. Certification, a medical data model and access to the point of care are in place. Your module can dock on as an integrated function, as a component or as a standalone medical device.

Do you work outside Germany?

The medical knowledge model is designed for international use, because SNOMED CT, LOINC and HL7 FHIR are international standards. Only ICD-10-GM and the connector to the local systems are specific to Germany.

Are you looking for investors?

We are in talks with investors who know the healthcare market. We provide documents after an initial conversation. Enquiries to info@pi-health.de.

Can I work with you?

There are no open positions right now, but speculative applications are welcome. Write to s.mueller@pi-health.de.

Support and contract

What happens if the internet goes down?

DocPad cannot be used offline, and we do not guarantee uninterrupted availability. That is why operation requires an independent procedure for accessing critical patient data during an outage, as well as a tested spare device. This is unpleasant to read, but settling it once calmly is better than discovering it under pressure.

Who do we contact if there are problems?

Contact technical support at support@docpad.cloud. Security incidents go to security@docpad.cloud, data protection matters to privacy@docpad.cloud.

How do we find out about new features?

Through the user information for each new version and through our mailing list. In the case of safety-relevant incidents, we notify all users by e-mail.

What if a diagnosis or finding is missing from the model?

Then let us know. The medical model is extended by doctors using an internal tool with a fixed approval process, and reviewed content is rolled out in versions.

The screen reflects in the treatment room. What can we do?

Adjust brightness and contrast to the ambient light, turn on automatic brightness and position the screen so that glare and shadows do not hide any information. If displays seem incomplete, stop using the device and report it to us.

How do we leave, and what happens to our data then?

When the contract ends, we provide your data to you in structured form and then delete it on your instruction. Because the final reports go back to your practice management system on an ongoing basis, your records remain complete even without us.