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

Terms, briefly explained.

80 terms on medical devices, data protection, data standards, everyday practice and DocPad itself.

A

Final reportDocPad

Created from the structured data capture and sent automatically to the practice management system after you sign. There is no manual export.

Medical historyPractice and care

Taking the patient's medical history: current complaints, previous illnesses, medication, family.

Doctor's letterPractice and care

Written report to co-treating doctors, for example with a referral.

Medical documentation obligationPractice and care

Doctors must record examination, diagnosis and treatment completely in the patient record (Section 630f of the German Civil Code (BGB)).

ATCData standards

Classification for active substances and medicinal products.

Data processing (DPA)Data protection and security

Contract between the practice and a service provider that governs how the service provider processes patient data on behalf of the practice.

B

FindingPractice and care

The result of an examination, for example a physical examination or a lab test.

Notified bodyRegulatory

Independent, state-designated testing organisation. It assesses whether a medical device and the manufacturer's quality management meet the MDR.

Reason for visitDocPad

Comes at the start of every data capture and pre-filters the input fields. You only see what fits the case.

C

C5Data protection and security

Audit catalogue of the German Federal Office for Information Security (BSI) for secure cloud services.

CE markingRegulatory

The mark with which the manufacturer declares that its product meets all EU requirements. Without CE, no distribution in the EU.

D

DiagnosisPractice and care

The medical determination of a disease. The diagnosis is always made by the doctor.

Differential diagnosisPractice and care

The list of diseases that come into question for certain complaints and have to be distinguished from one another.

DiGA (digital health application)Regulatory

An app on prescription that patients use themselves and that health insurers reimburse. DocPad is not a DiGA, because it is used by doctors.

DocPadDocPad

Software for doctors that captures medical history and examination as structured data and accompanies the diagnostic process. Certified Class IIa medical device.

DocPad in detail
GDPR (General Data Protection Regulation)Data protection and security

The EU General Data Protection Regulation. Health data is considered particularly worthy of protection under it.

E

EHDS (European Health Data Space)Data standards

The planned European Health Data Space, intended to make health data usable across the EU.

One record per patientDocPad

All of a patient's information is in one place in structured form, across all visits.

ConsentData protection and security

The patient's explicit agreement to the processing of their data. It can be withdrawn at any time.

How withdrawal of consent works in DocPad
ePA (electronic patient record)Data protection and security

The record provided by the health insurer, which holds the insured person's findings and documents.

EpisodeDocPad

One patient visit, from start to finish. When the episode is closed, the report goes to the practice management system.

Episodes and signature
EUDAMEDRegulatory

European database on medical devices, in which manufacturers, products and certificates are registered.

F

MisdiagnosisPractice and care

A diagnosis that turns out to be wrong, incomplete or delayed.

G

Instructions for use (IFU)Regulatory

The guide supplied by the manufacturer that describes the purpose, operation and limits of the product.

Go to the instructions for use
UsabilityRegulatory

How safely and easily a product can be operated in real everyday use. Tested for medical devices according to IEC 62366.

CountersignatureDocPad

If a junior doctor signs, the episode automatically goes to the supervisor for countersignature and only closes after that.

DocPad for MVZs
Health dataData protection and security

All information about a person's physical or mental health. It may only be processed under strict conditions.

H

GP-centred care (HZV)Practice and care

A care model in which the GP practice is the first point of contact and coordinates further treatment.

ManufacturerRegulatory

Whoever places a medical device on the market under their own name and is legally responsible for it.

HL7 FHIRData standards

A modern international standard for exchanging health data between systems. FHIR describes the format, not the content.

Hosting by STACKITDocPad

DocPad runs in the STACKIT cloud (Schwarz Digits) in Germany. STACKIT holds a C5 attestation and is certified to ISO 27001.

Data and hosting

I

ICD-10-GMData standards

The German version of the International Classification of Diseases. It is used for billing and statistics.

IEC 62304Regulatory

Standard for the life cycle of medical device software, from planning and testing to maintenance.

Content versionDocPad

A reviewed, frozen state of the knowledge model. This is how new medicine gets into the product without redeveloping the app.

InteroperabilityData standards

The ability of different systems to exchange data in a way that both sides understand it correctly.

iPad appDocPad

The interface that doctors and medical assistants use to work with DocPad in the practice.

ISiK (Information Technology Systems in Hospitals)Data standards

German FHIR-based specifications that define how hospital systems exchange data.

ISO 13485Regulatory

International standard for quality management for medical devices.

ISO 14971Regulatory

Standard for risk management for medical devices. Risks are identified, assessed and reduced as far as possible.

ISO 27001Data protection and security

International standard for information security. Certified providers have had their security processes audited.

K

Key UserPractice and care

A medical assistant from your team who knows DocPad in more depth. She is the internal contact person and trains new colleagues.

How a pilot works
HIS (hospital information system)Practice and care

The hospital counterpart to the PMS.

Class IIaRegulatory

Medium risk class. A Class IIa product must be assessed by a notified body before it may carry the CE marking.

About DocPad's certification
Clinical decision support (CDS)Practice and care

Software that gives doctors information and prompts for medical decisions. The decision stays with the human.

Conformity assessmentRegulatory

The assessment procedure that ends with a clear answer on whether a product complies with the MDR.

L

Local AdminDocPad

The facility's administration area. This is where user accounts, facilities and departments are managed.

LOINCData standards

International standard for coding laboratory values and measurements.

M

MDR (Medical Device Regulation)Regulatory

EU Regulation 2017/745 on medical devices. Since May 2021 it has set out the requirements a medical device must meet before it may be placed on the market in the EU.

Medical Device Software (MDSW)Regulatory

Software that is itself a medical device because it serves a medical purpose. It is subject to the same obligations as a physical device.

Medical knowledge modelDocPad

The heart of DocPad. Diagnoses, symptoms, findings, attributes and locations, coded according to SNOMED CT and ICD-10. It is versioned content, not program code.

Medical deviceRegulatory

A product that, according to its manufacturer, serves a medical purpose, such as diagnosing or treating diseases. Software on its own can also be a medical device.

MFA (medical assistant)Practice and care

She organises the practice workflow and handles many steps of patient admission.

DocPad for your team
Modelling and release toolDocPad

An internal tool that doctors use to extend the knowledge model. Every new content version is reviewed, frozen and only then rolled out.

MVZ (medical care centre)Practice and care

A facility in which several doctors, often from different specialties, work together.

DocPad for MVZs

P

PI Health GmbHDocPad

Manufacturer and distributor of DocPad. Based in Bavaria, made in Germany, developed by doctors.

About us
PMS brokerDocPad

The connector through which DocPad talks to practice management systems. One FHIR-based connection instead of a separate link for each PMS. Hospital information systems can also be addressed.

Post-market surveillanceRegulatory

The manufacturer's obligation to keep monitoring its product after market launch and to evaluate feedback.

PseudonymisationData protection and security

Data is altered so that it can no longer be attributed to a person without additional information.

PMS (practice management system)Practice and care

The central software of a medical practice for appointments, patient master data, documentation and billing.

Working with your PMS

Q

Quality management system (QMS)Regulatory

The defined processes a manufacturer uses to make sure development, production and support run in a controlled way. For medical devices, the standard ISO 13485 applies.

R

RED MedicalDocPad

Partner of PI Health that runs the generic FHIR connector to the practice management systems.

Partners
Risk classRegulatory

Medical devices are divided into Classes I, IIa, IIb and III according to their risk. The higher the class, the stricter the assessment.

Round TreeDocPad

The patient's condition across twelve body systems at a glance. The further an arm extends, the more the system is affected. Unremarkable systems stay green.

View the Round Tree

S

Interface (API)Data standards

A defined connection through which two programs exchange data.

SnapshotDocPad

A single, signed observation within an episode, for example one contact with the patient. This way it is always clear who captured what and when.

SNOMED CTData standards

The world's most comprehensive clinical terminology. Every clinical term has a unique code there, whatever the language.

Structured dataData standards

Data in fixed, coded fields instead of free text. Only then can it be analysed, compared and shared.

Structured captureDocPad

Medical history and findings are recorded using predefined, coded selection fields instead of free text.

Summative evaluationRegulatory

Final usability test with real users. It shows that the product can be used safely.

SupportDocPad

Help with DocPad is available at support@docpad.cloud.

Help and incidents

T

Telematics infrastructure (TI)Data protection and security

The secure network of the German healthcare system that connects practices, hospitals, pharmacies and health insurers.

U

UDI (Unique Device Identification)Regulatory

A unique identifier that makes every medical device traceable.

Supported PMSDocPad

DocPad has contracts with and access to medatixx, garrioPRO, Abasoft and other systems.

V

History, not a snapshot in timeDocPad

DocPad shows not just today's visit but how a patient has developed over time.

EncryptionData protection and security

Data is transformed so that only authorised persons can read it, both in transit and at rest.

Z

TimelineDocPad

Shows a patient's entire documented history, separated into outpatient, emergency and inpatient.

Dashboard and timeline
Class IIa certificationDocPad

Since May 2026, DocPad has been certified as a Class IIa medical device under the MDR. The notified body is Scarlet NB B.V. with identification number 3022.

Security and regulatory affairs
Intended purposeRegulatory

The binding description of what a medical device is intended for. It determines what the manufacturer may say about its product.

Intended purpose of DocPadDocPad

DocPad is intended for supportive, cross-indication documentation and for accompanying the diagnostic process by the treating physician. The diagnosis is always made by the doctor.

Go to the intended purpose
Twelve body systemsDocPad

The knowledge model organises medicine into twelve body systems. Capture in DocPad is structured the same way, and this is how the Round Tree shows them.

SystemRound TreeDefinition
Endocrine and metabolic systemMETCovers hormonal regulation and metabolic processes. Includes temperature regulation, fever, weight, genetic disorders, and also subjective sensations of heat (e.g. hot flushes).
Psychiatric systemPSYCovers mental content and perceptions such as depression, anxiety and hallucinations. Fatigue, sleep disorders, dreams and lack of drive are documented here.
Neurological systemNEURelates to the central and peripheral nervous system. Also includes the back of the head and the hair-bearing scalp. Lethargy and abnormal sensations (paraesthesia) are recorded here.
EyeAUGEIncludes eye structure and function, including visual acuity and visual field.
ENT systemHNOCovers ear, nose and throat as well as the face (e.g. facial dysmorphism, genetic syndromes).
Respiratory systemPULIncluding lungs, airways and chest wall. E.g. shortness of breath, cough, chest deformities.
Cardiovascular systemCVIncludes heart, blood vessels and peripheral oedema (excluding lymphoedema, see HÄM).
Digestive systemGICovers the gastrointestinal tract. Pain in the right or left upper and lower abdomen is classified here. Also includes intra-abdominal organs except the kidneys.
Urogenital systemUGIncludes kidneys, urinary tract, genitals, mammary gland and the suprapubic region. Suprapubic and perineal pain belong here.
Musculoskeletal systemBEWBones, muscles, joints, tendons, bursae. In some cases the specific anatomical location must be stated.
Dermatological systemDERMSkin and skin appendages, including hair and nails. Has its own anatomical location structure. Itching as an abnormal skin sensation is also included here as a symptom (cf. paraesthesia under NEU).
Blood, lymphatic and immune systemHÄMCovers immune response, inflammatory reactions, liquid cancers (e.g. leukaemias, lymphomas), immunotherapies and the lymphatic system (incl. lymph nodes, lymphatic vessels).

Source: DocPad instructions for use.