Establishing Trust in Medical Mobile Apps
There are more than 55,000 medically classified mobile apps available in public app stores, yet most are not independently assessed for patient use. The IEEE Global Medical Mobile App Assessment and Registry is a public repository of mobile medical apps that meet consensus-based criteria for clinical efficacy, technical quality, and ethical design.
Apps listed in the registry undergo a rigorous, multi-level evaluation and, once approved, receive a unique identifier. The assessment criteria were developed by an international, multidisciplinary group of experts, including clinicians, researchers, regulators, technologists, ethicists, patient advocates, and app developers.
Why the IEEE Registry Is Different
Medical apps listed in the IEEE Registry have successfully completed a rigorous three-tier independent evaluation conducted by a multidisciplinary panel of vetted experts in relevant clinical therapeutic domains, ethics, and technical standards. The assessment framework underpinning this process is currently being advanced toward formal recognition as a global technical standard: IEEE P3962 – Standard for Criteria Assessment Framework for Medical Mobile Health Applications (Apps). This initiative reflects IEEE’s commitment to establishing internationally harmonized, transparent, and evidence-based benchmarks to support the safe, effective, and ethical use of medical mobile health applications worldwide.
| Types of Repositories | Clinical Efficacy | Technical Soundness | Ethical Design | Publisher Verification | Global Standard Assessment | Publicly Accessible |
|---|---|---|---|---|---|---|
| Regulatory / Governmental Repository | ||||||
| Non-Profit / Therapeutic Association | ||||||
| Commercial Repositories | ||||||
| App Store (e.g., Apple, Google) | ||||||
| IEEE Global Medical App Registry |
Includes limited references to criteria areas
Why the IEEE SA
- Globally recognized leadership: The IEEE Standards Association (IEEE SA) is an internationally recognized standards development organization with more than 2,250 standards published or in progress, supported by global registries and conformity assessment programs.
- Adopted worldwide in healthcare: The IEEE 11073™ family of standards is acknowledged by the U.S. FDA and adopted in Europe through joint development with ISO, supporting the development of safe, effective, and interoperable medical devices.
- Aligned with global cybersecurity guidance: IEEE 2621.2 cybersecurity requirements for connected wireless medical devices are recognized by the FDA, and the IEEE 2621 certification program helps streamline premarket submissions in alignment with U.S., EU, and APACMed cybersecurity guidance.
- Global MAC address registry management: IEEE manages the assignment of unique 48-bit (EUI-48) and 64-bit (EUI-64) MAC addresses, ensuring worldwide uniqueness for Ethernet, Wi-Fi, and Bluetooth devices, with publicly accessible listings.
- Advancing ethical autonomous systems: For over a decade, IEEE has led ethical design initiatives in autonomous and intelligent systems through standards, training, and certification programs that address socio-technical challenges, promote interoperability and innovation, and protect human values, including governance frameworks and children’s data protection.
Medical App Publishers in a Competitive Global Market
Medical mobile apps operate globally, but trust remains a major barrier. Gaining regulatory approval across multiple regions is costly, time-consuming, and often limits market entry.
The IEEE Standards Association (IEEE SA) is a globally recognized authority, with health and technology standards referenced by the U.S. FDA, Europe, and other regions, and a leading portfolio of AI ethics standards. Inclusion in the IEEE Global Medical Mobile App Registry provides a trusted mark of credibility, demonstrating to patients, clinicians, payors, and regulators that your app delivers clinical value, is technically robust, and is ethically designed worldwide.
How to Use the IEEE Global Medical Mobile App Registry
The IEEE Global Medical Mobile App Registry is a public resource listing medical mobile apps assessed using the IEEE criteria framework. Apps in the registry are verified legal entities that voluntarily applied for review and met 85% or more of the requirements across clinical efficacy, technical soundness, and ethical design.
To maintain listing status, each new app version must be reassessed and is clearly noted on the app’s profile. The registry is open to patients, clinicians, regulators, researchers, payors, and other stakeholders seeking trusted, independently evaluated medical apps.
How the Assessment Criteria Were Developed
The assessment framework was developed under the guidance of an executive committee and created by 35 multidisciplinary experts from 10 countries, resulting in a neutral, consensus-based set of 140+ criteria.
Executive Committee
Dr. Yuri Quintana
Chair
Chief, Division of Clinical Informatics, Beth Israel Deaconess Medical Center; Assistant Professor of Medicine, Harvard Medical School
Gora Datta
Vice Chair
Teaching Faculty at UC Berkeley, College of Engineering; Chair, IEEE Orange County Section, (EMBS) Chapter; Chairman IEEE Southern California Council
Bruce Hecht
Vice Chair & Secretary
Electrical Engineer in Research & Design, ASML; CEO/CTO, VG2PLAY; IEEE Senior Member; Chair, IEEE Continuum of Care for Connected Health IC Program
Maria Palombini
Staff Lead
Global Director, Healthcare & Life Sciences Practice, IEEE SA
Criteria Development Committee
- Jo Aggarwal
Founder & CEO, Wysa - Zahid Ali
Chief Executive Officer (CEO), TECHMEDO Inc. - Liz Ashall-Payne
CEO and Founder, ORCHA - Shashaanka Ashili
Sr. Scientist, Digital medicine, Founding CEO, CureScience - Elizabeth White Baker, Ph.D.
Associate Professor, Virginia Commonwealth University - Simona Carini
Programmer/Analyst, University of California, San Francisco - Chris Boyd-Skinner
Director Clinical Governance, Australian Digital Health Agency - Gora Datta
Vice Chair IEEE Mobile Health App Registry, Vice Chair IEEE Blockchain TC, Engineering Faculty, University of California Berkeley - Kanza Faisal, Ph.D(c)
Applied Psychology, specializing in Clinical Psychology and Neuropsychology - Michele Ferrante, Ph.D
NIMH Program officer, Translational Digital and computational Psychiatry - Nelson B. Freimer, M.D
Distinguished Professor of Psychiatry & Biobehavioral Sciences and Human Genetics, Director, UCLA Center for Neurobehavioral Genetics - Bruce Hecht
CEO/CTO, VG2PLAY; IEEE Senior Member; Co-Chair, IEEE New Frontiers in the Continuum of Care for Connected Health Industry Connections Program - Colby Holliday
Director of Certification, DiME (Digital Medicine Society) - Ava Homiar
Research Assistant II, Beth Israel Deaconess Medical Center, Harvard University - Santiago Hors-Fraile
Director of Product, Adhera Health - Amanda L. Joseph
Director, Majestic Global Consulting Inc., Vancouver, British Columbia, Canada - Dr. Becky Inkster Ph.D
Digital Mental Health Neuroscientist; Co-Chair, IEEE Ethical Assurance of Data-Driven Technologies for Mental Healthcare Program; Advisor to Wysa; Cambridge University - Dr. Dimitris Kalogeropoulos, PhD
Chief Executive, Global Health & Digital Innovation Foundation, UK; Health Executive in Residence, UCL Global Business School for Health - Sadia Khan
Assistant Professor at School of Professional Psychology, University of Management and technology - Janel Loke
Assistant Director, MOH Office for Healthcare Transformation (MOHT), Singapore - Taj Magsi
Digital product Manager and Co Founder & COO, DilKiBaat - Narendra Mangra
Transdisciplinarian; Principal, GlobeNet LLC, IEEE Future Networks International Network Generations Roadmap (INGR) Co Chair, Co-Chair, IEEE New Frontiers in the Continuum of Care for Connected Health Industry Connections Program - Dr. Farooq Naeem
Chief Executive, Global Health & Digital Innovation Foundation, UK; Health Executive in Residence, UCL Global Business School for Health - Lance Nicholls, PharmD, ACHIP, FAMIA
President, Lancer Solution - Dr. Marzena Nieroda
Assistant Professor of Marketing and Commercialisation, Global Business School for Health, University College London - Maureen O’Connor Abbott
CHE, Director, Innovation Mental Health Commission of Canada - Yuri Quintana, PhD
Chief, Division of Clinical Informatics, Beth Israel Deaconess Medical Center; Assist. Professor of Medicine, Harvard Medical School; Senior Scientist, Homewood Research Institute - Tony Solomonides, PhD MSc(Math) MSc(AI) FAMIA FACMI
Program Director, Outcomes Research and Biomedical Informatics at the Research Institute, Endeavor Health - Peiling Yap
Chief Scientist, HealthAI
Clinical subject matter experts with demonstrated expertise in a defined therapeutic area are invited to apply to serve as Clinical Efficacy Assessors for the IEEE Global Medical Mobile App Registry. Contribute your expertise to advancing trusted, evidence-based digital health solutions worldwide.
FAQs for App Publishers
- How does an app publisher apply?
Submit an application through the registry, attest to meeting criteria, and provide supporting documentation. - What is the review process?
- Legal entity verification
- App submission
- Completeness review
- Independent technical and clinical assessment
- Final determination
- What does it cost?
There is a non-refundable app submission fee. Legal entity verification is free. Accepted apps require an annual subscription for ongoing assessment. The application fee is applied to the first-year subscription. Pricing is provided during application. - What information is required?
- App intended use, latest version, and publisher contacts
- Back-end access for assessors
- Relevant technical documentation
- How long does an app remain listed?
As long as the app continues to meet criteria for each version update and the annual subscription is maintained. - How long does review take?
Typically 6–8 weeks after submission, depending on completeness and complexity. - What criteria are used?
140+ points of criteria were developed by an international multidisciplinary group of experts based on three categories:- Technical soundness
- Ethical design
- Clinical efficacy
- Who conducts the assessments?
Independent industry experts and a clinical board of therapeutic subject matter experts. - Who can apply?
Medical mobile app developers worldwide that are legally established entities and can demonstrate clinical benefit. - What are the benefits of being listed?
- Cost-effective global credibility
- Increased trust from clinicians, patients, payers, and regulators
- Unique registry identifier and IEEE certification badge verifying the app’s assessment success
- Is participation mandatory?
No. Participation is voluntary. - Is the registry global?
Yes, though app availability may vary by country. - Do site visitors pay to access the registry?
No. Public registry access is free. - Can apps apply later?
Yes. Applications are accepted at any time.
FAQs for Registry Site Visitors
- How does the IEEE Global Medical Mobile App Assessment and Registry help to evaluate apps?
It independently assesses medical mobile apps using a comprehensive, standardized framework of technical, ethical, and clinical criteria. - What if an app isn’t listed?
It may not have applied, may be under review, or may not have met criteria. - How are apps selected?
Medical app publishers voluntarily submit their application for complete assessment, more score ≥85% in all criteria categories, and verify it is a legal entity. - How is quality ensured?
- Standardized consensus-based criteria
- Independent reviewers
- Multi-tier evaluation and assessment process
- Why was the registry created?
To help distinguish trustworthy medical apps amid rapid market growth and promote responsible innovation. - How does this help patients and clinicians?
- Provides a list of comprehensively assessed medical mobile apps
- Supports informed decision-making
- Reduces uncertainty using a trusted IEEE framework
- Does registry inclusion replace professional care?
No. Apps may support or supplement care but do not replace licensed healthcare providers. Patients should confer with physicians or licensed healthcare providers before using any medical mobile apps. - Does inclusion on the registry guarantee effectiveness?
No. Inclusion on the registry indicates that the app has demonstrated that it has achieved 85% or greater in the required framework criteria for technical soundness, ethical design and clinical benefit. The registry does not validate clinical outcomes or review clinical trials submissions. - Can an app lose its listing?
Yes, if subscription lapses or version updates fail to meet criteria. - Are assessors independent?
Yes. Assessors disclose conflicts of interest and demonstrate relevant expertise. - What information is available for each app?
Publisher details, intended use, assessed version, assessment date, availability, and access information. - Are privacy and security reviewed?
Yes. They are core components of the assessment. - Is my personal data shared?
No. No personal or patient data is shared during assessment. - Is this a ranking or rating system?
No. It is a registry of apps meeting IEEE criteria with ≥85% scores in all categories. - How can I provide feedback?
Email: [email protected]
Looking to Partner or General Inquiries
Use the IEEE Global Medical Mobile App Assessment and Registry for informed decision-making on which medical apps to support with confidence. Send your inquiries to Maria Palombini, [email protected].
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