{"id":3505,"date":"2025-05-06T10:05:47","date_gmt":"2025-05-06T08:05:47","guid":{"rendered":"https:\/\/nubisoft.io\/blog\/?p=3505"},"modified":"2025-06-30T12:36:55","modified_gmt":"2025-06-30T10:36:55","slug":"speech-to-text-vs-mdr-guidelines-for-software-providers","status":"publish","type":"post","link":"https:\/\/nubisoft.io\/blog\/speech-to-text-vs-mdr-guidelines-for-software-providers\/","title":{"rendered":"Speech to Text vs. MDR: Guidelines for Software Providers"},"content":{"rendered":"<div class=\"lazyblock-text-23rSGl wp-block-lazyblock-text\">\n  <div style=\"--size-margin-text-block: 0px;\" class=\"lazyblocks-text-wrapper wp-block-lazyblock-text\">\n    <div class=\"lazyblocks-text-columns-wrapper\">\n              <div class=\"lazyblocks-text-column\n                  lazyblocks-text-column-border\n                \" style=\"--size-padding-text-block: 20px;\">\n          <h1>Introduction<\/h1>\n<p><span style=\"font-weight: 400;\">Speech recognition tools are one of the most exciting new technologies in healthcare. The principle behind this type of application is simple: it turns speech into text. As a result, doctors no longer have to type information \u2013 they can simply dictate their notes, and the generated text appears automatically in the system. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Studies show that these types of tools actually save time.<\/span><\/p>\n<p><a href=\"https:\/\/www.nuance.com\/en-gb\/healthcare\/success\/clinical-speech-recognition-in-the-emergency-department.html\"><span style=\"font-weight: 400;\">Doctors using medical scribes complete documentation 35-40% faster than with traditional methods<\/span><\/a><span style=\"font-weight: 400;\">. It&#8217;s no wonder that <\/span><a href=\"https:\/\/phti.org\/ai-adoption-early-applications-impacts\/\"><span style=\"font-weight: 400;\">more than 60 companies are now developing these types of solutions<\/span><\/a><span style=\"font-weight: 400;\">, and that major EHR vendors are adding these capabilities to their medical systems.<\/span><\/p>        <\/div>\n      \n      \n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"lazyblock-inner-fb9FE wp-block-lazyblock-inner\">\n<div style=\"--inner-block-max-width:720px;\" class=\"lazyblock-inner-block-section wp-block-lazyblock-inner\">\n    \n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1248\" height=\"618\" src=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/05\/Reducing-doctors-time.png\" alt=\"This image compares doctors' documentation time with and without a transcription system. It shows that &quot;With no transcription system,&quot; documentation takes &quot;Up to 75 minutes per patient,&quot; while &quot;With a transcription system,&quot; it reduces to &quot;18-33 minutes per patient,&quot; resulting in &quot;&gt;15 hours saved weekly per doctor.&quot;\" class=\"wp-image-3600\" srcset=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/05\/Reducing-doctors-time.png 1248w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/05\/Reducing-doctors-time-300x149.png 300w\" sizes=\"auto, (max-width: 1248px) 100vw, 1248px\" \/><figcaption class=\"wp-element-caption\">Source: https:\/\/cejsh.icm.edu.pl\/cejsh\/element\/bwmeta1.element.ojs-doi-10_33119_EEIM_2020_58_4\/c\/2543-2328.pdf<\/figcaption><\/figure>\n\n\n<\/div>\n<\/div>\n\n<div class=\"lazyblock-text-1us67I wp-block-lazyblock-text\">\n  <div style=\"--size-margin-text-block: 0px;\" class=\"lazyblocks-text-wrapper wp-block-lazyblock-text\">\n    <div class=\"lazyblocks-text-columns-wrapper\">\n              <div class=\"lazyblocks-text-column\n                \" style=\"--size-padding-text-block: 0px;\">\n          <p><span style=\"font-weight: 400;\">Healthcare software must follow many rules, and the European Union has a complete set of requirements that vendors must follow when developing medical technology solutions. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Speech recognition tools face a double challenge: not only do they handle sensitive patient data from interviews, but they also incorporate artificial intelligence to improve speech recognition. This combination means that developers must navigate multiple regulatory frameworks when creating these solutions.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In the following article, we will try to present the legal situation of speech recognition tools from the perspective of the Medical Device Regulation. We will answer the question of whether, and if so in what situations, this type of software should apply for the famous CE mark.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The answer depends on many factors. We invite you to read on!<\/span><\/p>\n<p><strong>Table of contents:<\/strong><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><a href=\"#Functionalities-of-medical-scribes\">Functionalities of medical scribes<\/a>.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"#What-is-a-medical-device-and-what-is-not\">What is a medical device and what is not?<\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"#When-a-medical-scribe-is-not-MDR\">When a medical scribe is not MDR?<\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"#When-a-medical-scribe-is-MDR\"><span style=\"font-weight: 400;\">When is a medical scribe covered by MDR?<\/span><\/a><\/li>\n<li aria-level=\"1\"><a href=\"#summary\">Summary<\/a><\/li>\n<\/ul>\n<p><b><i>Disclaimer: We are not a law firm. Our article only serves to help you understand the current legal situation. For comprehensive understanding, we refer you to the original texts of the regulations we discuss here. If you need professional advice, we recommend contacting a law firm specializing in these issues.<\/i><\/b><\/p>\n<p><b><i>Disclaimer 2: This article is current as of its publication date. It will be updated when possible.<\/i><\/b><\/p>        <\/div>\n      \n      \n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"lazyblock-text-2ooOUw wp-block-lazyblock-text\" id=\"Functionalities-of-medical-scribes\">\n  <div style=\"--size-margin-text-block: 70px;\" class=\"lazyblocks-text-wrapper wp-block-lazyblock-text\" id=\"Functionalities-of-medical-scribes\">\n    <div class=\"lazyblocks-text-columns-wrapper\">\n              <div class=\"lazyblocks-text-column\n                          lazyblocks-text-big-font-quote\n        \" style=\"--size-padding-text-block: 32px;\">\n          <h1><b>Functionalities of medical scribes<\/b><\/h1>\n<p><span style=\"font-weight: 400;\">We need to be clear about which tools we&#8217;re discussing. The market offers many different options with varying features. For this analysis, we can identify 4 levels of speech-to-text tools for doctors: ranging from basic transcription apps to complete clinical assistants.<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><b>Level 0 &#8211; Basic medical transcription<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Conversion of speech to plain text<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">No medical structuring or formatting<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Used mainly for dictating notes, not necessarily patient conversations<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Example: standard text dictation tools that differ from basic scribes by correctly recognizing specific medical terms like &#8220;ophthalmoplasty&#8221; or abbreviations like &#8220;CRP,&#8221; &#8220;X-ray.&#8221;<br \/><br \/><\/span><\/li>\n<\/ul>\n<h2><b>Level 1 &#8211; Transcription with medical structuring<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Converts speech to text<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The tool can structure text into a ready medical note; highlighting basic documentation elements (e.g., history, examination)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sometimes these tools have speaker recognition features<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">They have interview summarization options<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Example: a tool listens to a doctor-patient conversation, transcribes everything in real-time, and then organizes the recorded text into a form ready to be added to electronic medical records.<br \/><br \/><\/span><\/li>\n<\/ul>\n<h2><b>Level 2 &#8211; Environmental listening + interpretation<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The application listens to, for example, a doctor-patient conversation, then presents a ready medical note<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>It extracts key information from the conversation, rejects side threads, presenting only information relevant from a treatment perspective<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>The tool creates, for example, consultation notes according to a selected template<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Example: a tool listens to a doctor-patient conversation, then creates a new note containing only relevant information, in a form ready to be added to electronic medical records.<br \/><br \/><\/span><\/li>\n<\/ul>\n<h2><b>Level 3 &#8211; Advanced clinical assistant<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Has all functions from level 2<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Tools typically integrated with EHR systems, having access to patient medical records<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Based on transcription, they suggest appropriate ICD codes and procedures<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Offer support in the diagnostic-therapeutic process, e.g., suggesting differential diagnoses, offering further diagnostic proposals, or therapeutic recommendations<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identification of potential risks and contraindications<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Example: A doctor conducts a consultation with a patient with chest pain. The assistant not only creates a structured interview note but also suggests possible diagnoses, reminds about key tests, warns about potential drug interactions based on the patient&#8217;s history, and proposes appropriate ICD codes for the diagnosis.<\/span><\/li>\n<\/ul>        <\/div>\n      \n      \n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"lazyblock-inner-1cUgu2 wp-block-lazyblock-inner\">\n<div style=\"--inner-block-max-width:720px;\" class=\"lazyblock-inner-block-section wp-block-lazyblock-inner\">\n    \n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1248\" height=\"618\" src=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/05\/Medical-scribe-advancement-levels.png\" alt=\" This image presents &quot;Medical scribe advancement levels&quot; as a series of increasing bars. Level 0 is labeled &quot;basic transcription,&quot; Level 1 adds &quot;+ medical structuring,&quot; Level 2 includes &quot;+ environmental listening &amp; interpretation,&quot; and Level 3 culminates in &quot;+ advanced clinical assistant,&quot; indicating a progression of skills.\" class=\"wp-image-3601\" srcset=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/05\/Medical-scribe-advancement-levels.png 1248w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/05\/Medical-scribe-advancement-levels-300x149.png 300w\" sizes=\"auto, (max-width: 1248px) 100vw, 1248px\" \/><figcaption class=\"wp-element-caption\">Medical scribe advancement levels<\/figcaption><\/figure>\n\n\n<\/div>\n<\/div>\n\n<div class=\"lazyblock-text-ZyCGtl wp-block-lazyblock-text\">\n  <div style=\"--size-margin-text-block: 70px;\" class=\"lazyblocks-text-wrapper wp-block-lazyblock-text\">\n    <div class=\"lazyblocks-text-columns-wrapper\">\n              <div class=\"lazyblocks-text-column\n                          lazyblocks-text-big-font-quote\n        \" style=\"--size-padding-text-block: 32px;\">\n          <p><span style=\"font-weight: 400;\">It&#8217;s easy to see that the higher the tool level, the more complex the solution. The most advanced applications offer much more than simple transcription, becoming a true clinical assistant.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">However, it should be added that the above categories are illustrative. The purpose of this classification was to highlight the most significant differences between these types of software and indicate the direction of these tools&#8217; development.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">This is reflected in the legal reality. <\/span><\/p>\n<blockquote>\n<p><span style=\"font-weight: 400;\">In other words: <strong>the more the tool interferes with the doctor&#8217;s competence, the more legal obligations arise from it.<\/strong><\/span><\/p>\n<\/blockquote>        <\/div>\n      \n      \n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"lazyblock-text-1ioSPk wp-block-lazyblock-text\" id=\"What-is-a-medical-device-and-what-is-not\">\n  <div style=\"--size-margin-text-block: 0px;\" class=\"lazyblocks-text-wrapper wp-block-lazyblock-text\" id=\"What-is-a-medical-device-and-what-is-not\">\n    <div class=\"lazyblocks-text-columns-wrapper\">\n              <div class=\"lazyblocks-text-column\n                \" style=\"--size-padding-text-block: 32px;\">\n          <h1><b>What is a medical device and what is not?<\/b><\/h1>\n<p><span style=\"font-weight: 400;\">To determine whether any software should be classified as a medical device, check these three key documents with specific guidance and examples:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\"><span style=\"font-weight: 400;\">Regulation MDR 2017\/745<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2020-09\/md_mdcg_2019_11_guidance_qualification_classification_software_en_0.pdf\"><span style=\"font-weight: 400;\">Document MDCG 2019-11<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/17921\"><span style=\"font-weight: 400;\">Document MEDDEV 2.1\/6<\/span><\/a><\/li>\n<\/ul>        <\/div>\n      \n      \n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"lazyblock-inner-G8CwC wp-block-lazyblock-inner\">\n<div class=\"lazyblock-inner-block-section wp-block-lazyblock-inner\">\n    \n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1248\" height=\"618\" src=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/05\/key-MDR-documents.png\" alt=\"This image displays a list titled &quot;Key MDR Documents.&quot; It outlines three important documents: &quot;MDCG 2019-11 Guidelines for classifying standalone software as medical devices,&quot; &quot;MEDDEV 2.1\/6 Guidance on software qualification under MDR and IVDR,&quot; and &quot;MDR 2017\/745 Comprehensive regulation for medical devices in the EU.\" class=\"wp-image-3630\" srcset=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/05\/key-MDR-documents.png 1248w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/05\/key-MDR-documents-300x149.png 300w\" sizes=\"auto, (max-width: 1248px) 100vw, 1248px\" \/><figcaption class=\"wp-element-caption\">Key MDR documents<\/figcaption><\/figure>\n\n\n<\/div>\n<\/div>\n\n<div class=\"lazyblock-text-6zNhC wp-block-lazyblock-text\" id=\"What-is-a-medical-device-and-what-is-not\">\n  <div style=\"--size-margin-text-block: 0px;\" class=\"lazyblocks-text-wrapper wp-block-lazyblock-text\" id=\"What-is-a-medical-device-and-what-is-not\">\n    <div class=\"lazyblocks-text-columns-wrapper\">\n              <div class=\"lazyblocks-text-column\n                \" style=\"--size-padding-text-block: 0px;\">\n          <p>The most important document is the MDR 2017\/745 \u2013 it establishes the legal framework that manufacturers must comply with, including requirements for software qualification, classification, and certification.\u00a0<\/p>\n<p><span style=\"font-weight: 400;\">The other two, MDCG 2019-11 and MEDDEV 2.1\/6, are regulatory guidelines that help manufacturers determine whether their software qualifies as a medical device and how to classify it.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ok, so what is a medical device?<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Firstly, it should be noted that the fact that an application is used in health care does not automatically mean that it is a medical device. This is stated in recital (19) in the preamble of the MDR regulation:\u00a0<\/span><\/p>\n<blockquote>\n<p><em><span style=\"font-weight: 400;\">It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, <strong>while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device<\/strong>.\u00a0<\/span><\/em><\/p>\n<\/blockquote>\n<p><span style=\"font-weight: 400;\">OK, so medical scribe can be designed to be used by doctors and still not be recognized as a medical device. So, where is the line that defines what is a medical device and what is not?<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The answer to this question can be found in Article 2 of the MDR. In this passage it appears that it is the so-called \u201cpurpose&#8221; that determines whether something is a medical device or not:<\/span><\/p>\n<blockquote>\n<p><em><span style=\"font-weight: 400;\">[&#8230;] &#8216;medical device&#8217; means any instrument, apparatus, appliance, <\/span><b>software<\/b><span style=\"font-weight: 400;\">, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific <\/span><b>medical purposes<\/b><span style=\"font-weight: 400;\">:<br \/><\/span><\/em><em>&#8211; diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,<br \/><\/em><em>&#8211; diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability [&#8230;]<\/em><\/p>\n<\/blockquote>\n<p><span style=\"font-weight: 400;\"><strong>The intended use is the official description of the designed functions of the device or software.<\/strong> This description is prepared by the manufacturer and is the most important part of the technical documentation of the product. In the certification process, this documentation and all descriptions are verified by the notifying body.\u00a0 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">So if a product serves a medical purpose \u2013 such as diagnosis or monitoring \u2013 this information must be included in the description, resulting in classification as a medical device. This description is also crucial because it helps determine the device&#8217;s classification (I, IIa, IIb, or III), which affects the complexity of the certification process.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In the case of medical scribes, the classification is not easy. Take a patient interview transcript \u2013 is it just a record, or could it actually provide diagnostic insight? It&#8217;s a difficult line to draw.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Moreover, the levels of tools described above make it clear that medical scribes differ from one another, and it is actually the specific functionalities that determine classification as a medical device.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">It depends on the characteristics of the tool and the reasons for its creation. This brings the discussion back to the different levels of tools mentioned earlier.<\/span><\/p>        <\/div>\n      \n      \n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"lazyblock-text-ZQLG2c wp-block-lazyblock-text\" id=\"When-a-medical-scribe-is-not-MDR\">\n  <div style=\"--size-margin-text-block: 20px;\" class=\"lazyblocks-text-wrapper wp-block-lazyblock-text\" id=\"When-a-medical-scribe-is-not-MDR\">\n    <div class=\"lazyblocks-text-columns-wrapper\">\n              <div class=\"lazyblocks-text-column\n                          lazyblocks-text-big-font-quote\n        \" style=\"--size-padding-text-block: 32px;\">\n          <h1><span style=\"font-weight: 400;\">When a medical scribe is not MDR?<\/span><\/h1>\n<p><span style=\"font-weight: 400;\">To properly determine when a medical scribe falls outside MDR classification, it&#8217;s essential to analyze its specific functionalities (which effectively define the &#8216;intended use&#8217; of the application) alongside the detailed guidelines established in the MDCG 2019-11 and MEDDEV 2.1\/6.\u00a0<\/span><\/p>\n<p>The MEDDEV 2.1\/6 guidelines are a particularly useful document. They contain a chapter on how to classify software. There is also a handy chart there:<\/p>        <\/div>\n      \n      \n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"lazyblock-inner-2l4dEK wp-block-lazyblock-inner\">\n<div class=\"lazyblock-inner-block-section wp-block-lazyblock-inner\">\n    \n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"646\" height=\"860\" src=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/04\/meddev-2.1.6-Figure-1.png\" alt=\"\" class=\"wp-image-3594\" srcset=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/04\/meddev-2.1.6-Figure-1.png 646w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/04\/meddev-2.1.6-Figure-1-225x300.png 225w\" sizes=\"auto, (max-width: 646px) 100vw, 646px\" \/><figcaption class=\"wp-element-caption\">Source: <a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/17921\/attachments\/1\/translations\/en\/renditions\/native\">https:\/\/ec.europa.eu\/docsroom\/documents\/17921\/attachments\/1\/translations\/en\/renditions\/native<\/a><\/figcaption><\/figure>\n\n\n<\/div>\n<\/div>\n\n<div class=\"lazyblock-text-175hRV wp-block-lazyblock-text\">\n  <div style=\"--size-margin-text-block: 21px;\" class=\"lazyblocks-text-wrapper wp-block-lazyblock-text\">\n    <div class=\"lazyblocks-text-columns-wrapper\">\n              <div class=\"lazyblocks-text-column\n                \" style=\"--size-padding-text-block: 0px;\">\n          <p>For transcription tools in particular, special attention must be paid to the rules governing the processing and modification of data.<\/p>\n<p><span style=\"font-weight: 400;\">In decision step 3, there is a question: <\/span><i><span style=\"font-weight: 400;\">Is the software performing an action on data different from storage, archival, communication or simple search?<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">If not, it does not have to be classified as a medical device. <\/span><span style=\"font-weight: 400;\">The answer to this question depends on the functionality available in the tool.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">So, going back to our classification of tool development levels: when software is classified as fitting into level 0 and 1 (basic transcription and <\/span><i><span style=\"font-weight: 400;\">lossless<\/span><\/i><span style=\"font-weight: 400;\"> structuring) probably <\/span><b>does not qualify<\/b><span style=\"font-weight: 400;\"> as a medical device. This is because it only performs the functions of recording, storing, and displaying information, without modifying their content.<\/span><\/p>\n<blockquote>\n<p><span style=\"font-weight: 400;\">MEDDEV 2.1\/6: <\/span><i><span style=\"font-weight: 400;\">if the software does not perform an action on data, or performs an action limited to storage, archival, communication, \u2018simple search\u2019 or lossless compression (i.e. using a compression procedure that allows the exact reconstruction of the original data) <\/span><\/i><b><i>it is not a medical device.<\/i><\/b><\/p>\n<\/blockquote>\n<p>Pure transcription can be considered a form of communication or archiving without generating new medical information. It simply converts speech to text, which is a technical process with no decision-making element in a medical context.<\/p>\n<p><span style=\"font-weight: 400;\">The same applies to lossless data structuring \u2013 this functionality typically involves organizing textual information in the sense of assigning it to previously defined categories, e.g., symptoms or recommendations. Structuring understood in this way can be interpreted as an action on medical data, although this data is not modified in any way, so it can be argued that the intended purpose of the software is just organization, and not \u201cmedical\u201d.<\/span><\/p>\n<blockquote>\n<p><strong>In summary: if a speech-to-text application offers just transcription of recordings and initial structuring consisting of text organization (not its modification or removal of fragments), then it probably should not be classified as a medical device.<\/strong><\/p>\n<\/blockquote>        <\/div>\n      \n      \n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"lazyblock-inner-Z1fnsha wp-block-lazyblock-inner\">\n<div class=\"lazyblock-inner-block-section wp-block-lazyblock-inner\">\n    \n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1248\" height=\"618\" src=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/05\/structuring-information-vs.-support-in-diagnosis-1.png\" alt=\"This image contains the text &quot;structuring information without modification&quot; above an inequality sign (\u2260), which is above the text &quot;support in diagnosis.&quot; This visually communicates that organizing information without changing it is not the same as providing assistance in the diagnostic process\" class=\"wp-image-3616\" srcset=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/05\/structuring-information-vs.-support-in-diagnosis-1.png 1248w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2025\/05\/structuring-information-vs.-support-in-diagnosis-1-300x149.png 300w\" sizes=\"auto, (max-width: 1248px) 100vw, 1248px\" \/><\/figure>\n\n\n<\/div>\n<\/div>\n\n<div class=\"lazyblock-text-1NygxI wp-block-lazyblock-text\" id=\"When-a-medical-scribe-is-MDR\">\n  <div style=\"--size-margin-text-block: 70px;\" class=\"lazyblocks-text-wrapper wp-block-lazyblock-text\" id=\"When-a-medical-scribe-is-MDR\">\n    <div class=\"lazyblocks-text-columns-wrapper\">\n              <div class=\"lazyblocks-text-column\n                \" style=\"--size-padding-text-block: 32px;\">\n          <h1><b>When a medical scribe is MDR?<\/b><\/h1>\n<p><span style=\"font-weight: 400;\">The situation changes when the structuring offered by the tool goes beyond simple organization and offers, for example, selecting the most important information from a patient interview, or a concise summary of the most important information (summarization). <\/span><\/p>\n<p><span style=\"font-weight: 400;\">These types of tools <\/span><b>may<\/b><span style=\"font-weight: 400;\"> qualify as medical software.<\/span><\/p>\n<p><strong>Arguments for this can be found in the <a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/17921\/attachments\/1\/translations\/en\/renditions\/native\">MEDDEV 2.1.6<\/a> document:<br \/><br \/><\/strong><\/p>\n<p><span style=\"font-weight: 400;\"><strong>On page 11, in the &#8220;Decision step 3&#8221; section:<\/strong> <\/span><\/p>\n<blockquote>\n<p><span style=\"font-weight: 400;\"><em>Software which is intended to create or modify medical information might be qualified as a medical device. If such alterations are made to facilitate the perceptual and\/or interpretative tasks performed by the healthcare professionals when reviewing medical information, (e.g. when searching the image for findings that support a clinical hypothesis as to the diagnosis or evolution of therapy) the software <\/em><\/span><em><b>could be a medical device.<\/b><\/em><\/p>\n<\/blockquote>\n<p>This fragment indicates that software creating or modifying medical information to facilitate perceptual and interpretative tasks performed by doctors may qualify as a medical device.<br \/><br \/><b><\/b><\/p>\n<p><span style=\"font-weight: 400;\"><strong>On page 11, in the section explaining types of data modifications:<\/strong> <\/span><\/p>\n<blockquote>\n<p><span style=\"font-weight: 400;\"><em>Alterations may include reconstruction, lossy compression, filtering, pattern recognition, modelling, interpolation, transformation, classification (e.g. scoring of tumors against specific criteria), segmentation, registration (e.g. mapping a data set to a model or atlas or to another data set), calculations, quantification, qualification (e.g. comparison of data against references), rendering, visualization, interpretation, etc.<br \/><\/em><\/span><\/p>\n<\/blockquote>\n<p><span style=\"font-weight: 400;\">Summarizing patient data and selecting the most important information involves interpretation, classification, and transformation of data \u2013 processes mentioned in this fragment.<br \/><br \/><\/span><\/p>\n<p><span style=\"font-weight: 400;\"><strong>On page 20, in example b) regarding Decision Support Software:<\/strong> <\/span><\/p>\n<blockquote>\n<p><span style=\"font-weight: 400;\"><em>In general, they are computer based tools which combine medical knowledge databases and algorithms with patient specific data. They are intended to provide healthcare professionals and\/or users with recommendations for diagnosis, prognosis, monitoring and treatment of individual patients<\/em>.<br \/><\/span><\/p>\n<\/blockquote>\n<p><span style=\"font-weight: 400;\">Software that summarizes patient data works similarly to decision support systems, as it analyzes patient data and provides doctors with information in an organized way, which supports their clinical decisions.<br \/><br \/><\/span><\/p>\n<p><span style=\"font-weight: 400;\"><strong>On page 7, in the definition of &#8220;Expert function software&#8221;:<\/strong> <\/span><\/p>\n<blockquote>\n<p><span style=\"font-weight: 400;\"><em>For the purpose of this document, the &#8216;expert function software&#8217; means software which is able to analyse existing information to generate new specific information according to the intended use of the software.<br \/><\/em><\/span><\/p>\n<\/blockquote>\n<p><span style=\"font-weight: 400;\">Summarizing patient data and selecting the most important information is a form of analyzing existing information to generate new information, which corresponds to the definition of software with an expert function.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In summary, a medical scribe that summarizes patient data or collected interview and selects the most important information may be classified as a medical device because:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It performs actions on data beyond simple storage<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It modifies or creates new medical information<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It supports doctors&#8217; decision-making processes<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It may have a direct impact on the diagnosis, treatment, or monitoring of a patient<\/span><\/li>\n<\/ul>\n<p><strong>Such features characterize level 2 and 3 tools according to our classification.<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">For Level 3 tools, the situation is clear \u2013 these are clinical AI assistants. Such applications have functionalities that directly meet the definition of medical devices and clinical decision support systems.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For example, based on patient data from the EHR, it can suggest differential diagnoses or suggest treatment plans\/recommendations.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Therefore, it is clear that the intended purpose of the tool in this case is to provide information to assist in the diagnosis, treatment, monitoring, mitigation, prediction, or prognosis of a disease.<\/span><\/p>\n<p><strong>In such a situation, there is a high probability that certification would be required.<\/strong><\/p>        <\/div>\n      \n      \n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"lazyblock-text-1qOaPH wp-block-lazyblock-text\" id=\"summary\">\n  <div style=\"--size-margin-text-block: 70px;\" class=\"lazyblocks-text-wrapper wp-block-lazyblock-text\" id=\"summary\">\n    <div class=\"lazyblocks-text-columns-wrapper\">\n              <div class=\"lazyblocks-text-column\n                  lazyblocks-text-column-border\n                \" style=\"--size-padding-text-block: 38px;\">\n          <h1><b>Summary<\/b><\/h1>\n<p><span style=\"font-weight: 400;\">So, that&#8217;s it.\u00a0<\/span><span style=\"font-weight: 400;\">Software using LLM to summarize clinical information will likely be classified as a medical device because it performs part of the work reserved for certified medical specialists, has a medical purpose, and involves risks to patients.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Key for legal classification is the degree to which the system interferes with the doctor&#8217;s decision-making process.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Manufacturers of advanced systems must meet a number of regulatory requirements, including CE certification, implementation of a quality management system, and ensuring human oversight.<\/span><\/p>\n<blockquote>\n<p><span style=\"font-weight: 400;\">However, it should be emphasized that the information presented in this article constitutes only our interpretation of the regulations. Currently, there is no clear position of regulatory authorities on this type of solution.<\/span><\/p>\n<\/blockquote>\n<p><span style=\"font-weight: 400;\">Nevertheless, more and more medical software providers in Europe are implementing speech-to-text solutions in their systems for doctors. If you are planning to add AI functionality to your healthcare software, ask us about our modules for software vendors, we have already done some work \ud83d\ude09<\/span><\/p>        <\/div>\n      \n      \n    <\/div>\n  <\/div>\n<\/div>\n\n<div class=\"lazyblock-contact-form-1MrrJl wp-block-lazyblock-contact-form\">\n\n    <div class=\"lazyblock-contact-form-contact-section wp-block-lazyblock-contact-form\">\n        <div class=\"lazyblock-contact-form-contact-section-inner\">\n\n                            <dialog id=\"ns-pop-up-dialog\" class=\"lazyblock-contact-form-dialog\">\n                                <div class=\"lazyblock-contact-form-contact-wrapper\">\n\n                    <div class=\"lazyblock-contact-form-contact-title-wrapper\">\n                        <h2 class=\"lazyblock-contact-form-contact-title\">\n                            Who are we?                        <\/h2>\n                        <p class=\"lazyblock-contact-form-contact-description\">\n                            At NubiSoft we work with healthcare software vendors, primarily across Europe. We develop new features, integration modules and AI components specifically for medical digital products. \nIf you&#8217;re thinking about adding new features to your medical software, there may be potential for working together. \n                        <\/p>\n\n                    <\/div>\n                    <script type=\"text\/javascript\" src=\" https:\/\/m.nubisoft.io\/form\/generate.js?id=3\"><\/script>\n                                            <button class=\"lazyblock-contact-form-close-button\">\n                        <\/button>\n                                    <\/div>\n                \n                <\/dialog>\n                <button class=\"lazyblock-contact-form-button\" id=\"ns-pickup-button\">\n                    Contact us                <\/button>\n\n            \n        <\/div>\n    <\/div>\n\n<\/div>\n\n<div class=\"lazyblock-posts-23lHxi wp-block-lazyblock-posts\">\n\n\n<div style=\"--size-margin-posts-block: 70px;\" class=\"lazyblocks-posts-wrapper wp-block-lazyblock-posts\">\n                                <h3 class=\"lazyblocks-posts-header\">People who read this article also read:<\/h3>                     \n\n        <div class=\"lazyblocks-posts-container\">\n\n                            <div class=\"lazyblocks-posts-single-wrapper\">\n                                        <a class=\"lazyblocks-posts-image-wrapper\" style=\"--post-thumbail-url: url('https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/12\/Healthcare-System-Modernization_title-150x150.png');\" href=\"https:\/\/nubisoft.io\/blog\/healthcare-system-modernization-two-proven-strategies\/\">\n\n\n                                                    <img loading=\"lazy\" decoding=\"async\" width=\"580\" height=\"287\" src=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/12\/Healthcare-System-Modernization_title-1024x507.png\" class=\"lazyblocks-posts-image wp-post-image\" alt=\"A title slide with NubiSoft logo introducing &quot;Two Strategies for: Healthcare System Modernization&quot; against a dark background with subtle circular elements.\" srcset=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/12\/Healthcare-System-Modernization_title-1024x507.png 1024w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/12\/Healthcare-System-Modernization_title-300x149.png 300w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/12\/Healthcare-System-Modernization_title-768x380.png 768w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/12\/Healthcare-System-Modernization_title-1200x594.png 1200w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/12\/Healthcare-System-Modernization_title.png 1248w\" sizes=\"auto, (max-width: 580px) 100vw, 580px\" \/>                                            <\/a>\n\n                    <div class=\"lazyblocks-posts-info-wrapper\">\n                                                    <div class=\"lazyblocks-posts-category-wrapper\">\n                                <a href=\"https:\/\/nubisoft.io\/blog\/category\/healthcare\/\" rel=\"category tag\">Healthcare<\/a> <a href=\"https:\/\/nubisoft.io\/blog\/category\/infrastructure\/\" rel=\"category tag\">Infrastructure<\/a> <a href=\"https:\/\/nubisoft.io\/blog\/category\/software-development\/\" rel=\"category tag\">Software Development<\/a> <a href=\"https:\/\/nubisoft.io\/blog\/category\/system-architecture\/\" rel=\"category tag\">System Architecture<\/a>                            <\/div>\n                        \n                        <span class=\"lazyblocks-posts-read-time\">1 min read<\/span>                    <\/div>\n\n\n                    <div class=\"lazyblocks-posts-title-wrapper\">\n                        <h2 class=\"lazyblocks-posts-title\"><a href=\"https:\/\/nubisoft.io\/blog\/healthcare-system-modernization-two-proven-strategies\/\">Healthcare System Modernization: Two Proven Strategies<\/a><\/h2>\n                        <a class=\"lazyblocks-posts-read-more\" href=\"https:\/\/nubisoft.io\/blog\/healthcare-system-modernization-two-proven-strategies\/\">Read more<\/a>\n                    <\/div>\n                <\/div>\n                            <div class=\"lazyblocks-posts-single-wrapper\">\n                                        <a class=\"lazyblocks-posts-image-wrapper\" style=\"--post-thumbail-url: url('https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/11\/1-150x150.png');\" href=\"https:\/\/nubisoft.io\/blog\/design-for-doctors-legal-and-usability-issues-in-medical-software\/\">\n\n\n                                                    <img loading=\"lazy\" decoding=\"async\" width=\"580\" height=\"287\" src=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/11\/1-1024x507.png\" class=\"lazyblocks-posts-image wp-post-image\" alt=\"A dark background presentation slide showing NubiSoft company logo with a cloud icon in turquoise green. The main heading reads &quot;Designing for doctors&quot; with a subtitle about legal and usability issues in medical software.\" srcset=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/11\/1-1024x507.png 1024w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/11\/1-300x149.png 300w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/11\/1-768x380.png 768w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/11\/1-1200x594.png 1200w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/11\/1.png 1248w\" sizes=\"auto, (max-width: 580px) 100vw, 580px\" \/>                                            <\/a>\n\n                    <div class=\"lazyblocks-posts-info-wrapper\">\n                                                    <div class=\"lazyblocks-posts-category-wrapper\">\n                                <a href=\"https:\/\/nubisoft.io\/blog\/category\/design\/\" rel=\"category tag\">Design<\/a> <a href=\"https:\/\/nubisoft.io\/blog\/category\/healthcare\/\" rel=\"category tag\">Healthcare<\/a>                            <\/div>\n                        \n                        <span class=\"lazyblocks-posts-read-time\">0 min read<\/span>                    <\/div>\n\n\n                    <div class=\"lazyblocks-posts-title-wrapper\">\n                        <h2 class=\"lazyblocks-posts-title\"><a href=\"https:\/\/nubisoft.io\/blog\/design-for-doctors-legal-and-usability-issues-in-medical-software\/\">Design for Doctors: Legal and Usability Issues in Medical Software<\/a><\/h2>\n                        <a class=\"lazyblocks-posts-read-more\" href=\"https:\/\/nubisoft.io\/blog\/design-for-doctors-legal-and-usability-issues-in-medical-software\/\">Read more<\/a>\n                    <\/div>\n                <\/div>\n                            <div class=\"lazyblocks-posts-single-wrapper\">\n                                        <a class=\"lazyblocks-posts-image-wrapper\" style=\"--post-thumbail-url: url('https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/02\/Blog-template-150x150.png');\" href=\"https:\/\/nubisoft.io\/blog\/nubisofts-role-in-advancing-health-e-services\/\">\n\n\n                                                    <img loading=\"lazy\" decoding=\"async\" width=\"580\" height=\"287\" src=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/02\/Blog-template-1024x507.png\" class=\"lazyblocks-posts-image wp-post-image\" alt=\"\" srcset=\"https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/02\/Blog-template-1024x507.png 1024w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/02\/Blog-template-300x149.png 300w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/02\/Blog-template-768x380.png 768w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/02\/Blog-template-1200x594.png 1200w, https:\/\/nubisoft.io\/blog\/wp-content\/uploads\/2024\/02\/Blog-template.png 1248w\" sizes=\"auto, (max-width: 580px) 100vw, 580px\" \/>                                            <\/a>\n\n                    <div class=\"lazyblocks-posts-info-wrapper\">\n                                                    <div class=\"lazyblocks-posts-category-wrapper\">\n                                <a href=\"https:\/\/nubisoft.io\/blog\/category\/case-study\/\" rel=\"category tag\">Case study<\/a> <a href=\"https:\/\/nubisoft.io\/blog\/category\/healthcare\/\" rel=\"category tag\">Healthcare<\/a>                            <\/div>\n                        \n                        <span class=\"lazyblocks-posts-read-time\">1 min read<\/span>                    <\/div>\n\n\n                    <div class=\"lazyblocks-posts-title-wrapper\">\n                        <h2 class=\"lazyblocks-posts-title\"><a href=\"https:\/\/nubisoft.io\/blog\/nubisofts-role-in-advancing-health-e-services\/\">NubiSoft\u2019s Role in Advancing Health E-Services<\/a><\/h2>\n                        <a class=\"lazyblocks-posts-read-more\" href=\"https:\/\/nubisoft.io\/blog\/nubisofts-role-in-advancing-health-e-services\/\">Read more<\/a>\n                    <\/div>\n                <\/div>\n                    <\/div>\n    <\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Speech recognition tools, also known as &#8216;medical scribes&#8217;, are becoming increasingly popular in doctors&#8217; offices. In this article we try to answer the question: should speech recognition tools be CE marked, and if so, why?<\/p>\n","protected":false},"author":13,"featured_media":3562,"comment_status":"open","ping_status":"open","sticky":false,"template":"post-2024.php","format":"standard","meta":{"_case_study_excerpt":"","footnotes":""},"categories":[221,5,3,45],"tags":[488,512,530,532],"class_list":["post-3505","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-healthcare","category-infrastructure","category-software-development","category-system-architecture","tag-ai","tag-healthcare-en","tag-mdr","tag-speech-to-text"],"_links":{"self":[{"href":"https:\/\/nubisoft.io\/blog\/wp-json\/wp\/v2\/posts\/3505","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nubisoft.io\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nubisoft.io\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nubisoft.io\/blog\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/nubisoft.io\/blog\/wp-json\/wp\/v2\/comments?post=3505"}],"version-history":[{"count":40,"href":"https:\/\/nubisoft.io\/blog\/wp-json\/wp\/v2\/posts\/3505\/revisions"}],"predecessor-version":[{"id":3904,"href":"https:\/\/nubisoft.io\/blog\/wp-json\/wp\/v2\/posts\/3505\/revisions\/3904"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nubisoft.io\/blog\/wp-json\/wp\/v2\/media\/3562"}],"wp:attachment":[{"href":"https:\/\/nubisoft.io\/blog\/wp-json\/wp\/v2\/media?parent=3505"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nubisoft.io\/blog\/wp-json\/wp\/v2\/categories?post=3505"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nubisoft.io\/blog\/wp-json\/wp\/v2\/tags?post=3505"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}