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It must connect regulated clinical functionality with patient and clinician experiences, healthcare data, security controls, interoperability, validation, and a plan for ongoing change.",{"type":27,"tag":28,"props":76,"children":77},{},[78],{"type":32,"value":79},"That means SaMD development, compliance, cybersecurity, UX, integrations, and software modernization cannot be treated as separate projects.",{"type":27,"tag":28,"props":81,"children":82},{},[83],{"type":32,"value":84},"They are parts of the same product strategy.",{"type":27,"tag":64,"props":86,"children":88},{"id":87},"key-takeaways",[89],{"type":32,"value":90},"Key takeaways",{"type":27,"tag":92,"props":93,"children":94},"ul",{},[95,101,106,111,116,121],{"type":27,"tag":96,"props":97,"children":98},"li",{},[99],{"type":32,"value":100},"SaMD may be the clinical core of a product, but it often operates inside a larger digital health platform.",{"type":27,"tag":96,"props":102,"children":103},{},[104],{"type":32,"value":105},"Intended use should shape product boundaries, risk analysis, architecture, validation, and regulatory planning from the beginning.",{"type":27,"tag":96,"props":107,"children":108},{},[109],{"type":32,"value":110},"Compliance is usually faster when traceability and validation are built into development rather than reconstructed afterward.",{"type":27,"tag":96,"props":112,"children":113},{},[114],{"type":32,"value":115},"Fast Heathcare Interoperability Resources (FHIR) and other interoperability standards help systems exchange data, but they do not guarantee that the information will be complete, understandable, or clinically useful.",{"type":27,"tag":96,"props":117,"children":118},{},[119],{"type":32,"value":120},"AI can accelerate bounded development and modernization tasks, but experienced people still need to define correct behavior and validate the result.",{"type":27,"tag":96,"props":122,"children":123},{},[124],{"type":32,"value":125},"Existing medical software does not always need a complete rewrite. A phased modernization may preserve critical functionality while reducing technical and operational risk.",{"type":27,"tag":64,"props":127,"children":129},{"id":128},"what-is-the-difference-between-samd-and-a-digital-health-platform",[130],{"type":32,"value":131},"What is the difference between SaMD and a digital health platform?",{"type":27,"tag":28,"props":133,"children":134},{},[135,137,146],{"type":32,"value":136},"Software as a Medical Device, or SaMD, is software that performs a medical function independently of a traditional physical medical device. Examples may include software used for diagnosis, monitoring, treatment recommendations, or patient support. (",{"type":27,"tag":138,"props":139,"children":143},"a",{"href":140,"rel":141},"https://artandlogic.com/newsletters/from-samd-to-digital-health-platforms-the-next-frontier-in-care/",[142],"nofollow",[144],{"type":32,"value":145},"Art+Logic",{"type":32,"value":147},")",{"type":27,"tag":28,"props":149,"children":150},{},[151],{"type":32,"value":152},"A digital health platform is the broader system around that function.",{"type":27,"tag":28,"props":154,"children":155},{},[156],{"type":32,"value":157},"It may include:",{"type":27,"tag":92,"props":159,"children":160},{},[161,166,171,176,181,186,191,196,201,206],{"type":27,"tag":96,"props":162,"children":163},{},[164],{"type":32,"value":165},"A patient-facing mobile application",{"type":27,"tag":96,"props":167,"children":168},{},[169],{"type":32,"value":170},"A clinician dashboard",{"type":27,"tag":96,"props":172,"children":173},{},[174],{"type":32,"value":175},"A regulated diagnostic or therapeutic function",{"type":27,"tag":96,"props":177,"children":178},{},[179],{"type":32,"value":180},"Connected-device integrations",{"type":27,"tag":96,"props":182,"children":183},{},[184],{"type":32,"value":185},"Healthcare data exchange",{"type":27,"tag":96,"props":187,"children":188},{},[189],{"type":32,"value":190},"Identity and access management",{"type":27,"tag":96,"props":192,"children":193},{},[194],{"type":32,"value":195},"Analytics and reporting",{"type":27,"tag":96,"props":197,"children":198},{},[199],{"type":32,"value":200},"Notifications and engagement tools",{"type":27,"tag":96,"props":202,"children":203},{},[204],{"type":32,"value":205},"Licensing and account administration",{"type":27,"tag":96,"props":207,"children":208},{},[209],{"type":32,"value":210},"Cloud infrastructure and operational systems",{"type":27,"tag":28,"props":212,"children":213},{},[214],{"type":32,"value":215},"SaMD describes the medical function and its regulatory significance.",{"type":27,"tag":28,"props":217,"children":218},{},[219],{"type":32,"value":220},"The platform describes how that function connects to the rest of the product, the organization, and the care environment.",{"type":27,"tag":28,"props":222,"children":223},{},[224,226,231],{"type":32,"value":225},"That distinction is becoming more important as healthcare software moves beyond standalone tools. Digital health platforms increasingly aggregate information from multiple sources, coordinate care across users, support longitudinal insights, and connect clinician workflows with patient applications and backend analytics. (",{"type":27,"tag":138,"props":227,"children":229},{"href":140,"rel":228},[142],[230],{"type":32,"value":145},{"type":32,"value":147},{"type":27,"tag":28,"props":233,"children":234},{},[235],{"type":32,"value":236},"Each connection creates value.",{"type":27,"tag":28,"props":238,"children":239},{},[240],{"type":32,"value":241},"It also creates responsibility.",{"type":27,"tag":28,"props":243,"children":244},{},[245],{"type":32,"value":246},"A new integration may eliminate duplicate data entry.",{"type":27,"tag":28,"props":248,"children":249},{},[250],{"type":32,"value":251},"It may also create another security boundary.",{"type":27,"tag":28,"props":253,"children":254},{},[255],{"type":32,"value":256},"A patient application may make care easier to access.",{"type":27,"tag":28,"props":258,"children":259},{},[260],{"type":32,"value":261},"It may also introduce questions about identity, consent, accessibility, connectivity, and data ownership.",{"type":27,"tag":28,"props":263,"children":264},{},[265],{"type":32,"value":266},"An analytics feature may help clinicians identify a meaningful pattern.",{"type":27,"tag":28,"props":268,"children":269},{},[270],{"type":32,"value":271},"It may also change how the product influences a clinical decision.",{"type":27,"tag":28,"props":273,"children":274},{},[275],{"type":32,"value":276},"The hard part isn’t adding more features, it’s understanding how those features change the behavior and risk of the whole system.",{"type":27,"tag":64,"props":278,"children":280},{"id":279},"why-should-intended-use-come-before-architecture",[281],{"type":32,"value":282},"Why should intended use come before architecture?",{"type":27,"tag":28,"props":284,"children":285},{},[286],{"type":32,"value":287},"Intended use defines what the software is supposed to do, who it is designed for, and how its output will affect care.",{"type":27,"tag":28,"props":289,"children":290},{},[291,293,299],{"type":32,"value":292},"Those answers influence risk classification, regulatory strategy, product requirements, architecture, testing, validation, and the evidence needed to support performance claims. Art+Logic’s SaMD guidance recommends defining intended use early rather than treating compliance as something to address after development. (",{"type":27,"tag":138,"props":294,"children":297},{"href":295,"rel":296},"https://artandlogic.com/newsletters/how-to-build-secure-compliant-samd-software-without-slowing-down-innovation/",[142],[298],{"type":32,"value":145},{"type":32,"value":147},{"type":27,"tag":28,"props":301,"children":302},{},[303],{"type":32,"value":304},"This sounds straightforward.",{"type":27,"tag":28,"props":306,"children":307},{},[308],{"type":32,"value":309},"It often isn’t.",{"type":27,"tag":28,"props":311,"children":312},{},[313],{"type":32,"value":314},"Suppose a feature displays information that a clinician will consider. Does it simply organize existing data, or does it recommend a course of treatment?",{"type":27,"tag":28,"props":316,"children":317},{},[318],{"type":32,"value":319},"Does an algorithm help prioritize cases, or does it determine which patients receive an intervention?",{"type":27,"tag":28,"props":321,"children":322},{},[323],{"type":32,"value":324},"Is a reminder a general engagement feature, or is it part of a therapeutic protocol?",{"type":27,"tag":28,"props":326,"children":327},{},[328],{"type":32,"value":329},"The answers can affect what belongs inside the regulated product boundary and how the feature should be evaluated.",{"type":27,"tag":28,"props":331,"children":332},{},[333],{"type":32,"value":334},"A useful early question is not merely:",{"type":27,"tag":28,"props":336,"children":337},{},[338],{"type":27,"tag":339,"props":340,"children":341},"strong",{},[342],{"type":32,"value":343},"What should the application do?",{"type":27,"tag":28,"props":345,"children":346},{},[347],{"type":32,"value":348},"It is:",{"type":27,"tag":28,"props":350,"children":351},{},[352],{"type":27,"tag":339,"props":353,"children":354},{},[355],{"type":32,"value":356},"What decision will someone make because of what the application does?",{"type":27,"tag":28,"props":358,"children":359},{},[360],{"type":32,"value":361},"That question brings engineering, product, clinical, security, quality, and regulatory stakeholders into the same conversation.",{"type":27,"tag":28,"props":363,"children":364},{},[365],{"type":32,"value":366},"It also gives developers something more useful than a feature list.",{"type":27,"tag":28,"props":368,"children":369},{},[370],{"type":32,"value":371},"It tells them what must not fail.",{"type":27,"tag":64,"props":373,"children":375},{"id":374},"how-can-compliance-support-faster-product-development",[376],{"type":32,"value":377},"How can compliance support faster product development?",{"type":27,"tag":28,"props":379,"children":380},{},[381],{"type":32,"value":382},"Compliance supports speed when it creates a clear, traceable relationship between intended use, requirements, risks, implementation, testing, and evidence.",{"type":27,"tag":28,"props":384,"children":385},{},[386],{"type":32,"value":387},"It slows teams down when those relationships have to be reconstructed near the end of a project.",{"type":27,"tag":28,"props":389,"children":390},{},[391],{"type":32,"value":392},"A team may reach what appears to be the final stage of development and discover that it cannot show:",{"type":27,"tag":92,"props":394,"children":395},{},[396,401,406,411,416,421],{"type":27,"tag":96,"props":397,"children":398},{},[399],{"type":32,"value":400},"Why a requirement exists",{"type":27,"tag":96,"props":402,"children":403},{},[404],{"type":32,"value":405},"Which identified risk it addresses",{"type":27,"tag":96,"props":407,"children":408},{},[409],{"type":32,"value":410},"How the requirement affected the design",{"type":27,"tag":96,"props":412,"children":413},{},[414],{"type":32,"value":415},"Where it was implemented",{"type":27,"tag":96,"props":417,"children":418},{},[419],{"type":32,"value":420},"How the behavior was tested",{"type":27,"tag":96,"props":422,"children":423},{},[424],{"type":32,"value":425},"Whether a later change altered the risk",{"type":27,"tag":28,"props":427,"children":428},{},[429],{"type":32,"value":430},"Then the documentation has to be rebuilt.",{"type":27,"tag":28,"props":432,"children":433},{},[434],{"type":32,"value":435},"Testing may need to be repeated.",{"type":27,"tag":28,"props":437,"children":438},{},[439],{"type":32,"value":440},"Architecture may have to change.",{"type":27,"tag":28,"props":442,"children":443},{},[444],{"type":32,"value":445},"A nearly complete feature may need to be reconsidered because no one clearly defined what it was supposed to prove.",{"type":27,"tag":28,"props":447,"children":448},{},[449],{"type":32,"value":450},"A better approach is to make traceability and validation normal outputs of development.",{"type":27,"tag":28,"props":452,"children":453},{},[454,456,461],{"type":32,"value":455},"Art+Logic’s guidance recommends using a traceable Secure Software Development Life Cycle, defining intended use early, integrating validation during development, working in small validated increments, and designing modular boundaries between regulated and nonregulated functionality where appropriate. (",{"type":27,"tag":138,"props":457,"children":459},{"href":295,"rel":458},[142],[460],{"type":32,"value":145},{"type":32,"value":147},{"type":27,"tag":28,"props":463,"children":464},{},[465,467,474],{"type":32,"value":466},"The regulatory framework also continues to evolve. The FDA’s Quality Management System Regulation became effective on February 2, 2026. It amended 21 CFR Part 820 and incorporated ISO 13485:2016 by reference, along with additional FDA requirements. (",{"type":27,"tag":138,"props":468,"children":471},{"href":469,"rel":470},"https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr",[142],[472],{"type":32,"value":473},"U.S. Food and Drug Administration",{"type":32,"value":147},{"type":27,"tag":28,"props":476,"children":477},{},[478],{"type":32,"value":479},"That change reinforces a larger point.",{"type":27,"tag":28,"props":481,"children":482},{},[483],{"type":32,"value":484},"A medical product may remain in use for years. The organization needs a development process that can accommodate new features, vulnerabilities, integrations, regulatory expectations, and platform changes while preserving control over product behavior.",{"type":27,"tag":28,"props":486,"children":487},{},[488],{"type":32,"value":489},"Good compliance work doesn’t remove uncertainty.",{"type":27,"tag":28,"props":491,"children":492},{},[493],{"type":32,"value":494},"It gives the team a disciplined way to manage it.",{"type":27,"tag":64,"props":496,"children":498},{"id":497},"why-is-cybersecurity-part-of-product-behavior",[499],{"type":32,"value":500},"Why is cybersecurity part of product behavior?",{"type":27,"tag":28,"props":502,"children":503},{},[504],{"type":32,"value":505},"Cybersecurity is not only an infrastructure concern. It affects who can use the product, what information they can access, what actions they can take, and what happens when the system is misused or compromised.",{"type":27,"tag":28,"props":507,"children":508},{},[509],{"type":32,"value":510},"Encryption, firewalls, and penetration testing may all matter.",{"type":27,"tag":28,"props":512,"children":513},{},[514],{"type":32,"value":515},"But so do questions such as:",{"type":27,"tag":92,"props":517,"children":518},{},[519,524,529,534,539,544,549,554],{"type":27,"tag":96,"props":520,"children":521},{},[522],{"type":32,"value":523},"Who can see a particular result?",{"type":27,"tag":96,"props":525,"children":526},{},[527],{"type":32,"value":528},"What happens when a clinician changes roles?",{"type":27,"tag":96,"props":530,"children":531},{},[532],{"type":32,"value":533},"Can access be revoked promptly?",{"type":27,"tag":96,"props":535,"children":536},{},[537],{"type":32,"value":538},"Which actions are recorded in the audit trail?",{"type":27,"tag":96,"props":540,"children":541},{},[542],{"type":32,"value":543},"What information appears in logs or analytics systems?",{"type":27,"tag":96,"props":545,"children":546},{},[547],{"type":32,"value":548},"How are third-party services evaluated?",{"type":27,"tag":96,"props":550,"children":551},{},[552],{"type":32,"value":553},"How does the organization respond to a vulnerable dependency?",{"type":27,"tag":96,"props":555,"children":556},{},[557],{"type":32,"value":558},"What should happen when unusual behavior is detected?",{"type":27,"tag":28,"props":560,"children":561},{},[562,564,571],{"type":32,"value":563},"The HIPAA Security Rule requires covered entities and business associates to use appropriate administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of electronic protected health information. Whether HIPAA applies to a particular product depends on the parties involved and the role the product plays in creating, receiving, maintaining, or transmitting protected information. (",{"type":27,"tag":138,"props":565,"children":568},{"href":566,"rel":567},"https://www.hhs.gov/hipaa/for-professionals/security/index.html",[142],[569],{"type":32,"value":570},"HHS.gov",{"type":32,"value":147},{"type":27,"tag":28,"props":573,"children":574},{},[575,577,583],{"type":32,"value":576},"Medical device cybersecurity has additional product-lifecycle implications. FDA guidance addresses cybersecurity considerations in device design, quality systems, and premarket submissions. 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It may also prevent an ordinary operational feature from becoming unnecessarily entangled with the most highly regulated part of the product.",{"type":27,"tag":28,"props":651,"children":652},{},[653],{"type":32,"value":654},"Modular design can help.",{"type":27,"tag":28,"props":656,"children":657},{},[658],{"type":32,"value":659},"But modularity does not simply mean creating more services, APIs, or repositories.",{"type":27,"tag":28,"props":661,"children":662},{},[663],{"type":32,"value":664},"A good boundary allows something important to change independently.",{"type":27,"tag":28,"props":666,"children":667},{},[668],{"type":32,"value":669},"A bad boundary just moves complexity somewhere else.",{"type":27,"tag":28,"props":671,"children":672},{},[673],{"type":32,"value":674},"Useful questions include:",{"type":27,"tag":92,"props":676,"children":677},{},[678,683,688,693,698,703,708],{"type":27,"tag":96,"props":679,"children":680},{},[681],{"type":32,"value":682},"Which components perform or directly support the medical function?",{"type":27,"tag":96,"props":684,"children":685},{},[686],{"type":32,"value":687},"Which features can change without changing the clinical behavior?",{"type":27,"tag":96,"props":689,"children":690},{},[691],{"type":32,"value":692},"Which information requires the strongest security controls?",{"type":27,"tag":96,"props":694,"children":695},{},[696],{"type":32,"value":697},"Which components need independent validation?",{"type":27,"tag":96,"props":699,"children":700},{},[701],{"type":32,"value":702},"Which integrations are likely to change frequently?",{"type":27,"tag":96,"props":704,"children":705},{},[706],{"type":32,"value":707},"Which services must remain available during an outage?",{"type":27,"tag":96,"props":709,"children":710},{},[711],{"type":32,"value":712},"Which parts of the product have different release schedules?",{"type":27,"tag":28,"props":714,"children":715},{},[716],{"type":32,"value":717},"The answers will vary by product.",{"type":27,"tag":28,"props":719,"children":720},{},[721],{"type":32,"value":722},"What matters is making the decisions intentionally.",{"type":27,"tag":64,"props":724,"children":726},{"id":725},"does-using-fhir-fast-heathcare-interoperability-resources-make-a-digital-health-product-interoperable",[727],{"type":32,"value":728},"Does using FHIR (Fast Heathcare Interoperability Resources) make a digital health product interoperable?",{"type":27,"tag":28,"props":730,"children":731},{},[732],{"type":32,"value":733},"FHIR makes structured healthcare information exchange easier, but using FHIR does not automatically make two systems operationally or clinically interoperable.",{"type":27,"tag":28,"props":735,"children":736},{},[737,739,746],{"type":32,"value":738},"FHIR is an HL7 standard for exchanging healthcare information electronically. 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maintainability",{"type":27,"tag":92,"props":1398,"children":1399},{},[1400,1405,1410,1415,1420],{"type":27,"tag":96,"props":1401,"children":1402},{},[1403],{"type":32,"value":1404},"Which technologies are approaching end of support?",{"type":27,"tag":96,"props":1406,"children":1407},{},[1408],{"type":32,"value":1409},"Where is institutional knowledge concentrated?",{"type":27,"tag":96,"props":1411,"children":1412},{},[1413],{"type":32,"value":1414},"Which areas are difficult or dangerous to change?",{"type":27,"tag":96,"props":1416,"children":1417},{},[1418],{"type":32,"value":1419},"What business or clinical capabilities must be preserved during modernization?",{"type":27,"tag":96,"props":1421,"children":1422},{},[1423],{"type":32,"value":1424},"What does the organization need the platform to make possible next?",{"type":27,"tag":28,"props":1426,"children":1427},{},[1428],{"type":32,"value":1429},"These questions are not separate from software development.",{"type":27,"tag":28,"props":1431,"children":1432},{},[1433],{"type":32,"value":1434},"They are what make good software development possible.",{"type":27,"tag":64,"props":1436,"children":1438},{"id":1437},"the-platform-is-the-product",[1439],{"type":32,"value":1440},"The platform is the product",{"type":27,"tag":28,"props":1442,"children":1443},{},[1444],{"type":32,"value":1445},"SaMD established that software can perform meaningful medical functions independently of traditional device hardware.",{"type":27,"tag":28,"props":1447,"children":1448},{},[1449],{"type":32,"value":1450},"The next challenge is connecting those functions to the people, information, devices, and systems involved in care—without making the product less secure, less understandable, or harder to change.",{"type":27,"tag":28,"props":1452,"children":1453},{},[1454],{"type":32,"value":1455},"That work requires more than technical implementation.",{"type":27,"tag":28,"props":1457,"children":1458},{},[1459],{"type":32,"value":1460},"It requires product strategy, healthcare domain knowledge, secure architecture, regulatory awareness, interoperability, UX design, validation, and a realistic plan for the full software lifecycle.",{"type":27,"tag":28,"props":1462,"children":1463},{},[1464,1466,1471],{"type":32,"value":1465},"Art+Logic designs and develops medical software ranging from SaMD and clinical support tools to connected-device applications, patient experiences, cloud platforms, and healthcare-data systems. The company also helps organizations update or recover existing products when aging technology, difficult architecture, or incomplete implementation is standing in the way. (",{"type":27,"tag":138,"props":1467,"children":1469},{"href":857,"rel":1468},[142],[1470],{"type":32,"value":145},{"type":32,"value":147},{"type":27,"tag":28,"props":1473,"children":1474},{},[1475],{"type":32,"value":1476},"Because in digital health, releasing the application is not the finish line.",{"type":27,"tag":28,"props":1478,"children":1479},{},[1480],{"type":32,"value":1481},"It is the beginning of a system the organization will need to understand, trust, secure, and improve for years.",{"type":27,"tag":64,"props":1483,"children":1485},{"id":1484},"faqs",[1486],{"type":32,"value":1487},"FAQs",{"type":27,"tag":1241,"props":1489,"children":1491},{"id":1490},"what-is-software-as-a-medical-device",[1492],{"type":32,"value":1493},"What is Software as a Medical Device?",{"type":27,"tag":28,"props":1495,"children":1496},{},[1497],{"type":32,"value":1498},"Software as a Medical Device, or SaMD, is software that performs a medical function independently of a traditional physical medical device. Depending on its intended use, it may support diagnosis, monitoring, treatment, clinical decision-making, or patient care.",{"type":27,"tag":1241,"props":1500,"children":1502},{"id":1501},"what-is-the-difference-between-samd-and-a-digital-health-platform-1",[1503],{"type":32,"value":131},{"type":27,"tag":28,"props":1505,"children":1506},{},[1507],{"type":32,"value":1508},"SaMD describes a software-based medical function. A digital health platform is the larger system that may connect that function with patient applications, clinician tools, device data, identity services, analytics, administration, and other healthcare systems.",{"type":27,"tag":1241,"props":1510,"children":1512},{"id":1511},"how-do-you-build-compliant-samd-software-without-slowing-development",[1513],{"type":32,"value":1514},"How do you build compliant SaMD software without slowing development?",{"type":27,"tag":28,"props":1516,"children":1517},{},[1518],{"type":32,"value":1519},"Define intended use and regulatory boundaries early, use a traceable development lifecycle, connect requirements to risks and tests, validate features incrementally, and produce documentation as part of development. This reduces the late rework caused by reconstructing evidence after the software is built.",{"type":27,"tag":1241,"props":1521,"children":1523},{"id":1522},"is-every-digital-health-application-subject-to-hipaa",[1524],{"type":32,"value":1525},"Is every digital health application subject to HIPAA?",{"type":27,"tag":28,"props":1527,"children":1528},{},[1529],{"type":32,"value":1530},"No. HIPAA generally applies to covered entities, business associates, and protected health information handled within those relationships. A product may still be subject to other privacy, medical-device, cybersecurity, consumer-protection, or state requirements.",{"type":27,"tag":1241,"props":1532,"children":1534},{"id":1533},"does-using-fhir-make-an-application-interoperable",[1535],{"type":32,"value":1536},"Does using FHIR make an application interoperable?",{"type":27,"tag":28,"props":1538,"children":1539},{},[1540],{"type":32,"value":1541},"Not by itself. FHIR provides a standard structure for exchanging healthcare information, but teams must still align terminology, identifiers, context, authorization, error handling, workflows, and the meaning of exchanged data.",{"type":27,"tag":1241,"props":1543,"children":1545},{"id":1544},"can-ai-be-used-to-develop-or-modernize-medical-software",[1546],{"type":32,"value":1547},"Can AI be used to develop or modernize medical software?",{"type":27,"tag":28,"props":1549,"children":1550},{},[1551],{"type":32,"value":1552},"Yes. AI can accelerate repetitive implementation, analysis, testing, and documentation tasks. Experienced professionals should still control architecture, clinical behavior, security, code review, testing, validation, and regulatory evidence.",{"type":27,"tag":1241,"props":1554,"children":1556},{"id":1555},"should-legacy-medical-software-be-rebuilt-from-scratch-1",[1557],{"type":32,"value":959},{"type":27,"tag":28,"props":1559,"children":1560},{},[1561],{"type":32,"value":1562},"Not always. A phased modernization may be safer and more economical when the existing product contains valuable workflows, integrations, validated behavior, and institutional knowledge. The right approach depends on platform risk, maintainability, product goals, and the cost of preserving or recreating existing functionality.",{"type":27,"tag":1241,"props":1564,"children":1566},{"id":1565},"why-is-usability-important-in-clinical-software",[1567],{"type":32,"value":1568},"Why is usability important in clinical software?",{"type":27,"tag":28,"props":1570,"children":1571},{},[1572],{"type":32,"value":1573},"Clinical software is often used under time pressure and in high-consequence environments. Clear information, predictable behavior, efficient workflows, accessible design, and effective error recovery can affect whether users understand and act on the software’s output correctly.",{"title":8,"searchDepth":1575,"depth":1575,"links":1576},3,[1577,1578,1579,1580,1581,1582,1583,1584,1585,1586,1587,1588,1597,1598],{"id":66,"depth":1575,"text":69},{"id":87,"depth":1575,"text":90},{"id":128,"depth":1575,"text":131},{"id":279,"depth":1575,"text":282},{"id":374,"depth":1575,"text":377},{"id":497,"depth":1575,"text":500},{"id":601,"depth":1575,"text":604},{"id":725,"depth":1575,"text":728},{"id":874,"depth":1575,"text":877},{"id":956,"depth":1575,"text":959},{"id":1114,"depth":1575,"text":1117},{"id":1231,"depth":1575,"text":1234,"children":1589},[1590,1592,1593,1594,1595,1596],{"id":1243,"depth":1591,"text":1246},4,{"id":1277,"depth":1591,"text":1280},{"id":1306,"depth":1591,"text":1309},{"id":1335,"depth":1591,"text":1338},{"id":1364,"depth":1591,"text":1367},{"id":1393,"depth":1591,"text":1396},{"id":1437,"depth":1575,"text":1440},{"id":1484,"depth":1575,"text":1487,"children":1599},[1600,1601,1602,1603,1604,1605,1606,1607],{"id":1490,"depth":1591,"text":1493},{"id":1501,"depth":1591,"text":131},{"id":1511,"depth":1591,"text":1514},{"id":1522,"depth":1591,"text":1525},{"id":1533,"depth":1591,"text":1536},{"id":1544,"depth":1591,"text":1547},{"id":1555,"depth":1591,"text":959},{"id":1565,"depth":1591,"text":1568},"markdown","content:cperez:2026-07-21:building-digital-health-platforms-beyond-samd.md","content","cperez/2026-07-21/building-digital-health-platforms-beyond-samd.md","cperez/2026-07-21/building-digital-health-platforms-beyond-samd","md",1784782372630]