Resource Name
1
Digital Medicine: A Primer on Measurement (Digital Biomarkers article)
2
Belmont Report (Office for Human Research Protections - HHS)
3
Building the case for actionable ethics in digital health research supported by artificial intelligence (BMC Medicine Article)
4
Connected and Open Research Ethics (CORE) Platform (ReCODE Health)
5
Electronic Code of Federal Regulations: Part 46: Protection of Human Subjects
6
FDA Policy for the Protection of Human Subjects
7
Healthcare Industry Cybersecurity Task Force: Report on Improving Cybersecurity In the Healthcare Industry (Office of the Assistant Secretary for Preparedness and Response)
8
HIPAA Privacy Rule for Researchers (OCR)
9
Hippocratic Oath for Connected Medical Devices (I am the Cavalry)
10
Legal and Ethical Architecture for Patient-Centered Outcomes Research (PCOR) Data (ONC)
11
mHealth Research Applied to Regulated and Unregulated Behavioral Health Sciences - Camille Nebeker ( The Journal of Law, Medicine & Ethics article)
12
ReCODE Health, including Digital Health Checklist (ReCODE)
13
Action Plan EU Commission; White Paper on Artificial Intelligence: A European approach to excellence and trust
14
Essential considerations for successful qualification of novel methodologies (European Medicines Agency)
15
International Compilation of Human Research Standards (OHRP)
16
WHO: Global Strategy on Digital Health 2020-2024
17
GDPR
18
Clinical Decision Support Software - Draft (FDA; CDRH; CBER; CDER)
19
Digital Health, Digital Medicine, Digital Therapeutics (DTx): What’s the difference? (Digital Medicine Society)
20
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID‐19
21
RPM Digital Health Implementation Playbook (American Medical Association)
22
Xcertia Guidelines (joint effort - AMA, AHA, HIMSS, and DHX Group)
23
AMA Telehealth Implementation Framework
24
AMA Remote Patient Monitoring Implementation Playbook
25
2021 Advancing Regulatory Science at FDA: FOCUS AREAS OF REGULATORY SCIENCE
26
Clinical outcomes assessment (The Professional Society for Health Economics and Outcomes Research)
27
Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials (CTTI)
28
Software-Enabled Clinical Trials (Elektra Labs)
29
Study Data Standards Resources (FDA)
30
Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials (CTTI)
31
Framework for Real-World Evidence Program - 2018 (FDA)
32
Real-World Evidence (FDA)
33
STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies (BMJ)
34
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics (FDA)
35
BEST (Biomarkers, EndpointS, and other Tools) Resource - from the FDA-NIH Biomarker Working Group (Food and Drug Administration/National Institutes of Health)
36
Biomarker Guidance and Reference Materials (FDA)
37
DDT qualification program (FDA)
38
The Playbook: Digital Clinical Measures (Digital Medicine Society)
39
Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)
40
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
41
Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health
42
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
43
Fast Facts: Digital medicine -- Measurement
44
21st Century CURES Act - Section 3060: Clarifying Medical Software Regulation is on page 98 (Congress)
45
Device Software Functions Including Mobile Medical Applications (Food and Drug Administration)
46
Digital Health Guidances (FDA)
47
Digital Health Resources (FDA)
48
General Wellness: Policy for Low Risk Devices (FDA; CDRH)
49
Policy for Device Software Functions and Mobile Medical Applications (FDA; CDRH; CBER)
50
Qualification of Digital Technologies (European Medicines Agency)
51
Usability.gov: Improving the User Experience
52
US Digital Service: Digital Services Playbook
53
Federal Notice: Medicare and Medicaid Rule (CMS; HHS)
54
Navigating Digital Medicine Coding and Payment (AMA)
55
Your Guide to Reimbursement for Remote Patient Monitoring (Validic)
56
Computerized Systems Used in Clinical Investigations
57
Mobile Health App Developers' Guidance (FTC)
58
Off-The-Shelf Software Use in Medical Devices (FDA; CDRH)
59
Software as a Medical Device (SaMD): Clinical Evaluation - 2017 (International Medical Device Regulators Forum - IMDRF; FDA)
60
The Device Development Process (FDA)
61
ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes (International Organization for Standardization)
62
Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests (FDA; CDRH)
63
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (FDA; CDRH; CBER)
64
Overview of Device Regulation (FDA)
65
Standards Index (Institute of Electrical and Electronics Engineers - IEEE )
66
Common Data Element Initiative at the National Library of Medicine (NIH)
67
Data Modernization Action Plan (DMAP) (FDA)
68
Data Trusts: A new tool for data governance (Element AI)
69
FHIR® US Core Implementation Guide (ONC, HL7)
70
Guiding Principles (CARIN Alliance)
71
Mechanisms to Govern Responsible Sharing of Open Data: A Progress Report (Sage)
72
Permitted Uses and Disclosures for Health Care Operations (U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) and the Office for Civil Rights (OCR))
73
Responsible, practical genomic data sharing that accelerates research (Nature Review - Genetics article)
74
Trusted Exchange Framework and Common Agreement (ONC)
75
AdvaMed Center for Digital Health
76
Cybersecurity for Networked Medical Devices Containing Off-The-Shelf Software (FDA; CDRH)
77
Cybersecurity Standard for Connected Diabetes Devices (Diabetes Technology Society)
78
Framework for Improving Critical Infrastructure Cybersecurity (NIST)
79
Menlo Report (Department of Homeland Security)
80
Postmarket Management of Cybersecurity in Medical Devices (FDA; CDRH)
81
Special Publication 1800-8 - Securing Wireless Infusion Pumps in Healthcare Delivery Organizations (NIST)
82
Building resilient medical technology supply chains with a software bill of materials
83
Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (FDA; CDRH)
84
FDA's Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)
85
2018 Report to Congress - Annual Update on the Adoption of a Nationwide System for the Electronic Use and Exchange of Health Information (ONC)
86
Technology Modernization Action Plan (TMAP) (FDA)
87
Application Design Research Reports (Nielsen Norman Group)
88
User Experience Design Articles (Interaction Design Foundation)
89
The Encyclopedia of Human-Computer Interaction, 2nd ed. (Interaction Design Foundation)
90
Get Started with Design (Stanford d.school)
91
User Experience (UX) Measures (NODE.Health)
92
Digitizing Clinical Trials (Nature Digital Medicine)
93
Optimizing Mobile Clinical Trials by Engaging Patients and Sites (CTTI)
94
Fairness in Precision Medicine - Kadija Ferryman (Data & Society paper)
95
Digital inclusion as a social determinant of health
96
Applying Big Data to Address the Social Determinants of Health in Oncology: Workshop and Publication (National Academies of Sciences, Engineering, and Medicine)
97
Glossary from BEST Resource (Food and Drug Administration/National Institutes of Health)
98
Federal Information Security Modernization Act (FISMA)
99
Federal Risk and Authorization Management Program (FedRAMP)
100
Artificial Intelligence: An Accountability Framework for Federal Agencies and Other Entities
101
Regulation of the European Parliament and of the Council, Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act) and Amending Certain Union Legislative Acts
102
Digital Health Vendor Assessment For Clinical Trials
103
Guiding Principles for the Privacy of Personal Health Data
104
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
105
Data Standards for Drug and Biological Product Submissions Containing Real-World Data
106
Recommendations for the safe, effective use of adaptive CDS in the US healthcare system: an AMIA position paper
107
Merck's Code of Digital Ethics
108
No-Cost Tools from the US Federal Cybersecurity and Infrastructure Security Agency (CISA)
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Resource URL
Date of Publication
Tag
General Comments
Email
https://www.karger.com/Article/FullText/500413
2019
Clinical care
Clinical research
Digital clinical measures
Digital health products
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
April 18, 1979
Clinical research
Equitable access to underserved populations (demographic, socioeconomic, digital divide)
Ethical concerns & protections (including privacy)
Developing Legal and Ethical Frameworks
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-019-1377-7
July 17, 2019
Use of AI/ML and Big Data analytics
Ethical concerns & protections (including privacy)
Developing Legal and Ethical Frameworks
https://thecore-platform.ucsd.edu/
Ethical concerns & protections (including privacy)
Developing Legal and Ethical Frameworks
https://www.ecfr.gov/cgi-bin/text-idx?SID=7eb50ad845adbca40ea97ff6adafa85a&mc=true&node=pt45.1.46&rgn=div5
May 25, 2021
Clinical research
Ethical concerns & protections (including privacy)
Developing Legal and Ethical Frameworks
https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/fda-policy-protection-human-subjects
June 18, 1991
Clinical research
Ethical concerns & protections (including privacy)
Developing Legal and Ethical Frameworks
https://www.phe.gov/Preparedness/planning/CyberTF/Documents/report2017.pdf
June 20, 2017
Security protocols and requirements
Ethical concerns & protections (including privacy)
Developing Legal and Ethical Frameworks
https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html
December 18, 2017
Clinical research
Ethical concerns & protections (including privacy)
Developing Legal and Ethical Frameworks
https://iamthecavalry.org/issues/medical/oath/
January 19, 2016
Security protocols and requirements
Ethical concerns & protections (including privacy)
Developing Legal and Ethical Frameworks
https://www.healthit.gov/topic/scientific-initiatives/pcor/legal-and-ethical-architecture-patient-centered-outcomes-research-pcor-data-architecture
October 15, 2018
Data governance and sharing
Ethical concerns & protections (including privacy)
Developing Legal and Ethical Frameworks
https://escholarship.org/uc/item/8ds8n4s5
2020
Clinical research
Ethical concerns & protections (including privacy)
Developing Legal and Ethical Frameworks
https://recode.health/
Clinical research
Ethical concerns & protections (including privacy)
Developing Legal and Ethical Frameworks
https://ec.europa.eu/info/sites/info/files/commission-white-paper-artificial-intelligence-feb2020_en.pdf
February 19, 2020
Use of AI/ML and Big Data analytics
General technical/computing infrastructure
International legal frameworks
Developing Legal and Ethical Frameworks
https://www.ema.europa.eu/en/documents/other/essential-considerations-successful-qualification-novel-methodologies_en.pdf
December 5, 2017
Clinical research
International legal frameworks
Developing Legal and Ethical Frameworks
https://www.hhs.gov/ohrp/sites/default/files/2020-international-compilation-of-human-research-standards.pdf
November 5, 2019
Clinical research
Ethical concerns & protections (including privacy)
International legal frameworks
Developing Legal and Ethical Frameworks
https://www.who.int/docs/default-source/documents/gs4dhdaa2a9f352b0445bafbc79ca799dce4d.pdf
2021
Digital health products
International legal frameworks
Developing Legal and Ethical Frameworks
https://gdpr.eu/
Data governance and sharing
International legal frameworks
Developing Legal and Ethical Frameworks
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software
September 2019
Health software (excluding EMR)
Clinical care
Digital health products
Medical devices
Regulatory Guidelines, Standards, and Best Practices
https://medium.com/digital-medicine-society-dime/digital-health-digital-medicine-digital-therapeutics-dtx-whats-the-difference-92344420c4d5
November 10, 2019
Digital health products
Clinical care
Glossary
Regulatory Guidelines, Standards, and Best Practices
https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.12874
August 31, 2020
Digital clinical measures
Clinical care
Clinical research
Regulatory Guidelines, Standards, and Best Practices
https://www.ama-assn.org/system/files/2018-12/digital-health-implementation-playbook.pdf
2018
Digital clinical measures
Clinical care
Regulatory Guidelines, Standards, and Best Practices
https://www.himss.org/sites/hde/files/media/file/2020/04/17/xcertia-guidelines-2019-final.pdf
August 12, 2019
Health software (excluding EMR)
Clinical care
Regulatory Guidelines, Standards, and Best Practices
https://www.ama-assn.org/practice-management/digital/telehealth-implementation-playbook-overview
2020
Clinical care
Regulatory Guidelines, Standards, and Best Practices
https://www.ama-assn.org/practice-management/digital/remote-patient-monitoring-implementation-playbook-overview
2018
Clinical care
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/science-research/advancing-regulatory-science/focus-areas-regulatory-science#:~:text=The%202021%3A%20Advancing%20Regulatory%20Science,inform%20regulatory%20decision%2Dmaking%20and
January 11, 2021
Real-world evidence
Use of AI/ML and Big Data analytics
Clinical Research
Regulatory Guidelines, Standards, and Best Practices
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4610138/
August 24, 2015
Clinical Research
Digital clinical measures
Regulatory Guidelines, Standards, and Best Practices
https://ctti-clinicaltrials.org/wp-content/uploads/2021/07/CTTI_Developing_Novel_Endpoints_2021_Recommendations.pdf
June 2017
Clinical Research
Digital clinical measures
Regulatory Guidelines, Standards, and Best Practices
https://blog.andreacoravos.com/software-enabled-clinical-trials-8da53f4cd271
September 4, 2017
Clinical Research
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources
March 31, 2021
Clinical Research
Validation and adherence to standards
Study design (including subject training)
Digital health products
Regulatory Guidelines, Standards, and Best Practices
https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/mobile-devices-recommendations.pdf
July 2018
Clinical Research
Digital clinical measures
Validation and adherence to standards
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/media/120060/download
December 2018
Clinical Research
Digital health products
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
November 30, 2020
Clinical Research
Digital health products
Regulatory Guidelines, Standards, and Best Practices
https://www.bmj.com/content/372/bmj.m4856
January 12, 2021
Clinical Research
Study design (including subject training)
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-documents-using-real-world-data-and-real-world-evidence-fda-drugs-and-biologics-guidance
May 2019
Clinical Research
Study design (including subject training)
Digital health products
Regulatory Guidelines, Standards, and Best Practices
https://www.ncbi.nlm.nih.gov/books/NBK326791/
January 25, 2021
Glossary
Clinical Research
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/drugs/cder-biomarker-qualification-program/biomarker-guidances-and-reference-materials
April 2, 2018
Clinical Research
Validation and adherence to standards
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/drugs/development-approval-process-drugs/drug-development-tool-ddt-qualification-programs
February 25, 2021
Clinical Research
Digital health products
Validation and adherence to standards
Regulatory Guidelines, Standards, and Best Practices
https://playbook.dimesociety.org/
April 7, 2021
Clinical care
Clinical Research
Validation and adherence to standards
Regulatory Guidelines, Standards, and Best Practices
https://www.nature.com/articles/s41746-020-0260-4
April 14, 2020
Clinical care
Clinical Research
Validation and adherence to standards
Regulatory Guidelines, Standards, and Best Practices
https://www.nature.com/articles/s41746-020-0237-3
March 13, 2020
Clinical care
Clinical Research
Validation and adherence to standards
Regulatory Guidelines, Standards, and Best Practices
https://www.karger.com/Article/Fulltext/509725
2020
Clinical care
Clinical Research
Validation and adherence to standards
Regulatory Guidelines, Standards, and Best Practices
https://www.karger.com/Article/FullText/514730
2021
Clinical Research
Validation and adherence to standards
Regulatory Guidelines, Standards, and Best Practices
https://www.amazon.com/Fast-Facts-Digital-Medicine-Measurement-ebook/dp/B086R6NBP2
April 3, 2020
Digital clinical measures
Regulatory Guidelines, Standards, and Best Practices
https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf
December 13, 2016
Digital health products
Health software (excluding EMR)
Medical devices
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/medical-devices/digital-health/device-software-functions-including-mobile-medical-applications#a
November 5, 2019
Digital health products
Health software (excluding EMR)
Medical devices
Validation and adherence to standards
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content
October 6, 2020
Digital health products
Glossary
Validation and adherence to standards
Medical devices
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/medical-devices/digital-health
March 24, 2021
Digital health products
Ethical concerns & protections (including privacy)
Validation and adherence to standards
Medical devices
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices
September 26, 2019
Digital health products
Medical devices
Validation and adherence to standards
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications
September 26, 2019
Digital health products
Health software (excluding EMR)
Validation and adherence to standards
Medical devices
Regulatory Guidelines, Standards, and Best Practices
https://www.ema.europa.eu/en/documents/other/questions-answers-qualification-digital-technology-based-methodologies-support-approval-medicinal_en.pdf
June 1, 2020
Digital health products
International legal frameworks
Validation and adherence to standards
Clinical Research
Regulatory Guidelines, Standards, and Best Practices
https://www.usability.gov/
Digital health products
Study design (including subject training)
Regulatory Guidelines, Standards, and Best Practices
https://playbook.cio.gov/
Digital health products
General technical/computing infrastructure
Validation and adherence to standards
Health software (excluding EMR)
Regulatory Guidelines, Standards, and Best Practices
https://www.federalregister.gov/documents/2021/01/19/2021-00805/medicare-program-cy-2021-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part
January 19, 2021
Reimbursement
Medical devices
Clinical care
Regulatory Guidelines, Standards, and Best Practices
https://www.ama-assn.org/system/files/2018-12/playbook-resources-step-5-coding-payment-REV1.pdf
2018
Reimbursement
Medical devices
Clinical care
Regulatory Guidelines, Standards, and Best Practices
https://validic.com/your-guide-to-reimbursement-for-remote-patient-monitoring/
July 20, 2020
Reimbursement
Medical devices
Clinical care
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computerized-systems-used-clinical-investigations
May 10, 2007
Health software (excluding EMR)
Technical, Security, and User Considerations and Validation
https://www.ftc.gov/tips-advice/business-center/guidance/mobile-health-apps-interactive-tool
April 2016
Health software (excluding EMR)
Technical, Security, and User Considerations and Validation
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices
September 26, 2019
Health software (excluding EMR)
Technical, Security, and User Considerations and Validation
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170921-samd-n41-clinical-evaluation_1.pdf
September 21, 2017
Health software (excluding EMR)
Technical, Security, and User Considerations and Validation
https://www.fda.gov/patients/learn-about-drug-and-device-approvals/device-development-process
January 4, 2018
Medical devices
Technical, Security, and User Considerations and Validation
https://www.iso.org/standard/59752.html
2020
Medical devices
Technical, Security, and User Considerations and Validation
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/logical-observation-identifiers-names-and-codes-vitro-diagnostic-tests
June 15, 2018
Medical devices
Technical, Security, and User Considerations and Validation
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-data-systems-medical-image-storage-devices-and-medical-image-communications-devices
September 27, 2019
Medical devices
Technical, Security, and User Considerations and Validation
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
September 4, 2020
Medical devices
Technical, Security, and User Considerations and Validation
https://standards.ieee.org/standard/index.html?utm_source=mm_link&utm_campaign=find&utm_medium=std&utm_term=find%20standards&_ga=2.39557223.573907904.1596478123-705605739.1595433153
Medical devices
Technical, Security, and User Considerations and Validation
https://cde.nlm.nih.gov/
Data governance and sharing
Validation and adherence to standards
Clinical Research
Technical, Security, and User Considerations and Validation
https://www.fda.gov/about-fda/reports/data-modernization-action-plan
March 3, 2021
Data governance and sharing
General technical/computing infrastructure
Technical, Security, and User Considerations and Validation
https://hello.elementai.com/rs/024-OAQ-547/images/Data_Trusts_EN_201914.pdf
March 14, 2019
Data governance and sharing
General technical/computing infrastructure
Clinical Research
Security protocols and requirements
Technical, Security, and User Considerations and Validation
http://hl7.org/fhir/us/core/STU3.1.1/
August 8, 2020
Data governance and sharing
General technical/computing infrastructure
Validation and adherence to standards
Technical, Security, and User Considerations and Validation
https://www.carinalliance.com/about-us/#:~:text=CARIN's%20work%20is%20guided%20by,consumers%20and%20their%20care%20teams.
Data governance and sharing
Ethical concerns & protections (including privacy)
Technical, Security, and User Considerations and Validation
https://sage-bionetworks.github.io/governanceGreenPaper/
September 9, 2020
Data governance and sharing
Ethical concerns & protections (including privacy)
Technical, Security, and User Considerations and Validation
https://www.hhs.gov/sites/default/files/exchange_health_care_ops.pdf
January 2016
Data governance and sharing
Ethical concerns & protections (including privacy)
Clinical care
Technical, Security, and User Considerations and Validation
https://read.qxmd.com/read/32694666/responsible-practical-genomic-data-sharing-that-accelerates-research
October 2020
Data governance and sharing
Ethical concerns & protections (including privacy)
Clinical Research
Technical, Security, and User Considerations and Validation
https://www.healthit.gov/sites/default/files/page/2019-04/FINALTEFCAQTF41719508version.pdf
April 19, 2019
Data governance and sharing
Ethical concerns & protections (including privacy)
Technical, Security, and User Considerations and Validation
https://digitalhealth.advamed.org/
Security protocols and requirements
Clinical care
Technical, Security, and User Considerations and Validation
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/information-healthcare-organizations-about-fdas-guidance-industry-cybersecurity-networked-medical
January 14, 2005
Security protocols and requirements
Medical devices
Validation and adherence to standards
Technical, Security, and User Considerations and Validation
https://www.diabetestechnology.org/dtsec.shtml
November 25, 2017
Security protocols and requirements
Medical devices
Health software (excluding EMR)
Validation and adherence to standards
Technical, Security, and User Considerations and Validation
https://nvlpubs.nist.gov/nistpubs/CSWP/NIST.CSWP.04162018.pdf
April 16, 2018
Security protocols and requirements
Ethical concerns & protections (including privacy)
Device/software user design
Equitable access to underserved populations (demographic, socioeconomic, digital divide)
Technical, Security, and User Considerations and Validation
https://www.dhs.gov/sites/default/files/publications/CSD-MenloPrinciplesCORE-20120803_1.pdf
August 3, 2012
Security protocols and requirements
Ethical concerns & protections (including privacy)
Equitable access to underserved populations (demographic, socioeconomic, digital divide)
Technical, Security, and User Considerations and Validation
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices
December 28, 2016
Security protocols and requirements
Medical devices
Device/software user design
Technical, Security, and User Considerations and Validation
https://www.nccoe.nist.gov/sites/default/files/library/sp1800/hit-wip-nist-sp1800-8.pdf
August 2018
Security protocols and requirements
Medical devices
Device/software user design
Technical, Security, and User Considerations and Validation
https://www.nature.com/articles/s41746-021-00403-w
February 23, 2021
Security protocols and requirements
General technical/computing infrastructure
Digital health products
Technical, Security, and User Considerations and Validation
https://www.fda.gov/media/145022/download
January 2021
Use of AI/ML and Big Data analytics
Health software (excluding EMR)
Medical devices
Technical, Security, and User Considerations and Validation
https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device
January 12, 2021
Use of AI/ML and Big Data analytics
Health software (excluding EMR)
Medical devices
Technical, Security, and User Considerations and Validation
https://www.healthit.gov/sites/default/files/page/2018-12/2018-HITECH-report-to-congress.pdf
2018
General technical/computing infrastructure
Data governance and sharing
Equitable access to underserved populations (demographic, socioeconomic, digital divide)
Technical, Security, and User Considerations and Validation
https://www.fda.gov/about-fda/reports/fdas-technology-modernization-action-plan
September 18, 2019
General technical/computing infrastructure
Data governance and sharing
Security protocols and requirements
Technical, Security, and User Considerations and Validation
https://www.nngroup.com/reports/topic/applications/
Validation and adherence to standards
Device/software user design
Technical, Security, and User Considerations and Validation
https://www.interaction-design.org/literature/article/overview
Validation and adherence to standards
Device/software user design
Study design (including subject training)
Technical, Security, and User Considerations and Validation
https://www.interaction-design.org/literature/book/the-encyclopedia-of-human-computer-interaction-2nd-ed
January 1, 2014
Validation and adherence to standards
Device/software user design
Study design (including subject training)
Technical, Security, and User Considerations and Validation
https://dschool.stanford.edu/resources/get-started-with-design
Validation and adherence to standards
Device/software user design
Technical, Security, and User Considerations and Validation
https://nodehealth.org/ux-measures/
Validation and adherence to standards
Device/software user design
Digital health products
Study design (including subject training)
Technical, Security, and User Considerations and Validation
https://www.nature.com/articles/s41746-020-0302-y
July 31, 2020
Study design (including subject training)
Clinical Research
Fit for Purpose, Disparities, Access, and Inclusion
https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/ctti_recommendations_-_mct_engaging_patients_and_sites_final.pdf
February 21, 2019
Study design (including subject training)
Clinical Research
Ethical concerns & protections (including privacy)
Fit for Purpose, Disparities, Access, and Inclusion
https://datasociety.net/wp-content/uploads/2018/02/Data.Society.Fairness.In_.Precision.Medicine.Feb2018.FINAL-2.26.18.pdf (23)
February 26, 2018
Equitable access to underserved populations (demographic, socioeconomic, digital divide)
Clinical care
Clinical Research
Fit for Purpose, Disparities, Access, and Inclusion
https://www.nature.com/articles/s41746-021-00413-8
March 17, 2021
Equitable access to underserved populations (demographic, socioeconomic, digital divide)
Clinical care
Fit for Purpose, Disparities, Access, and Inclusion
https://www.nationalacademies.org/event/10-21-2019/applying-big-data-to-address-the-social-determinants-of-health-in-oncology-a-workshop
October 2019
Measuring health outcome disparities
Equitable access to underserved populations (demographic, socioeconomic, digital divide)
Fit for Purpose, Disparities, Access, and Inclusion
https://www.ncbi.nlm.nih.gov/books/NBK338448/
January 25, 2021
Glossary
Validation and adherence to standards
Medical devices
https://www.congress.gov/113/plaws/publ283/PLAW-113publ283.pdf
December 18, 2014
Security protocols and requirements
Regulatory Guidelines, Standards, and Best Practices
https://www.fedramp.gov/program-basics/
N/A
Security protocols and requirements
Data governance and sharing
Regulatory Guidelines, Standards, and Best Practices
https://www.gao.gov/products/gao-21-519sp
June 30, 2021
Use of AI/ML and Big Data analytics
Developing Legal and Ethical Frameworks
https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1623335154975&uri=CELEX%3A52021PC0206
April 21, 2021
Use of AI/ML and Big Data analytics
International legal frameworks
https://www.healthxl.com/reports/digital-health-vendor-assessment-for-clinical-trials
September 2021
Data governance and sharing
Device/software user design
Digital health products
Ethical concerns & protections (including privacy)
International legal frameworks
Validation and adherence to standards
Technical, Security, and User Considerations and Validation
An open-source operational due diligence guidance to facilitate vendor qualification. With a standardized template, vendors will have a response package prepared with the majority of expected documentation in a format that sponsors are ready to accept and review. While this framework is meant to serve as a guidance for industry, it can easily be adapted to suit individual needs and specifications and can also be adapted for usage in non-clinical trials and other cases.
https://cdn.cta.tech/cta/media/media/membership/pdfs/final-cta-guiding-principles-for-the-privacy-of-personal-health-and-wellness-information.pdf
2021
Data governance and sharing
Ethical concerns & protections (including privacy)
Regulatory Guidelines, Standards, and Best Practices
A publication by the Consumer Technology Association
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-electronic-health-records-and-medical-claims-data-support-regulatory
September 2021
Real-world evidence
Regulatory Guidelines, Standards, and Best Practices
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-drug-and-biological-product-submissions-containing-real-world-data
October 2021
Regulatory Guidelines, Standards, and Best Practices
Real-world evidence
Data governance and sharing
https://academic.oup.com/jamia/article/28/4/677/6100038?login=true
January 15, 2021
Health software (excluding EMR)
Digital health products
Medical devices
Use of AI/ML and Big Data analytics
Validation and adherence to standards
https://www.emdgroup.com/company/responsibility/us/products-businesses/CoDE-Code_of_Digital_Ethics.pdf
July 2021
Ethical concerns & protections (including privacy)
Equitable access to underserved populations (demographic, socioeconomic, digital divide)
Developing Legal and Ethical Frameworks
Fit for Purpose, Disparities, Access, and Inclusion
Merck has established a Code of Digital Ethics (CoDE) to cement strong ethics around its digital health activities, a first for a large company in the healthcare industry. The CoDE, based on a decade’s worth of digital ethics learnings, governs how Merck approaches all activities relating to the development, commercialization and use of digital products and processes. The core principles of the CoDE are autonomy, justice, beneficence, non-maleficence, and transparency. These principles ensure Merck operates in a safe, transparent, and accountable manner that benefits patients, the healthcare sector, and society at large. Other healthcare companies should consider establishing CoDEs that complement these guiding ethical principles.
https://www.dimesociety.org/wp-content/uploads/March-CISA-2022-.pdf
March 24, 2022
Data governance and sharing
Ethical concerns & protections (including privacy)
108 records
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