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Medicare Policy at the Crossroads: Addressing Artificial Intelligence and Software

AdvaMed collaborated with CapView Strategies to develop this new report on improving coverage and payment for AI/software in Medicare. This work builds on the analysis and recommendations from an earlier collaboration with a specific focus on AI/software.

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Press Release

New National Poll Reveals Majority of Adults Recognize the Impact of Artificial Intelligence in Health Care

AdvaMed  released the findings of a new national poll exploring the public perceptions of the use of artificial intelligence (AI) in health care. Gain a better understanding of people’s reaction to the changing digital health landscape by reviewing the survey results here.

The AdvaMed Digital Health Tech promotes the critical role of data and digital medical technologies in transforming health care. The Center advocates for public policies and best practices that advance digital health innovation and adoption and build trust among all stakeholders. 

As a thought leader and convener, AdvaMed Digital Health Tech is home to a wide range of medical and digital technology companies that are driving transformative advances in digital health that enable new insights, support health and wellness, improve patient interventions and outcomes, and enhance the efficiency of health care delivery. 

AdvaMed Digital Health Tech member companies are innovators throughout the health care ecosystem, including medical device, digital therapeutic, pharmaceutical, and consumer and data technology companies. 

This site is designed to provide selected digital health resources for AdvaMed Digital Health Tech members and interested stakeholders and we welcome your outreach and feedback at [email protected]

Digital Medtech 

Emerging and converging technologies are enabling the collection of novel kinds of data, aggregation of ever-larger data sets, increasingly sophisticated data analysis, and augmented intelligence. Current and emerging elements of health care powered or enhanced by these data capabilities include new insights into individual and population health; real-time, continuous, remote patient monitoring; distributed care outside of traditional settings; advanced diagnoses through wearable, implantable and ingestible technologies; outcomes-based care arrangements; more effective management of population health; autonomous and/or remote interventions; enhanced clinical decision support; product research and development; and more. 

AdvaMed Digital Health Tech member companies are driving these transformative advances in digital health and creating tremendous value with respect to improved patient outcomes and the quality and efficiency of health care delivery.  

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AdvaMed Digital Health Tech Members

Browse a list of member companies who currently belong to AdvaMed community of digital medical technology manufacturers.

AdvaMed Digital Health Tech Policy  

AdvaMed Digital Health Tech focuses on four core policy areas: Regulation, Payment and Health Care Delivery, Data Stewardship and Privacy, and Cybersecurity. 

Industry Resources

These resources are posted for information only. AdvaMed does not endorse or support any of the content provided.

Stakeholder White Papers & Reports

The AI Effect: How Artificial Intelligence is Making Health Care More Human – MIT Technology Review and GE Healthcare, 2020 

Digital Health Technology: Global Case Studies of Health Care Transformation – Deloitte, October 2019 

Current State and Near-Term Priorities for AI-Enabled Diagnostic Support Software in Health Care – Duke Margolis Center for Health Policy, June 2019 

The Role of Personal Data in Healthcare – International Pharmaceutical & Medical Device Privacy Consortium (IPMPC), April 2019 

Roundtable Report: Sharing and Utilizing Data for Health Applications – Center for Open Data Enterprise, April 2019 

Unlocking the power of data to improve health outcomes: five trends to watch – EY, January 2019 

Digital Health Implementation Playbook – American Medical Association, December 2018 

Perspectives and Good Practices for AI and Continuously Learning Systems in Healthcare – Xavier Health, August 2018 

When the human body is the biggest data platform, who will capture value?: Life Sciences 4.0 Securing value through data-driven platforms – EY, May 2018 

Journal Articles 

Digital Medicine: A Primer on Measurement Digital Biomarkers 

Using Digital Health Technology to Better Generate Evidence and Deliver Evidence-Based Care Journal of the American College of Cardiology 

Potential Liability for Physicians Using Artificial Intelligence JAMA 

Digital health: a path to validation npj Digital Medicine 

FDA Guidance Regarding Medical Devices 

FDA Digital Health Center of Excellence 

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) 

Draft Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (2017) 

General Principles of Software Validation (2002) 

Medical Device Accessories – Describing Accessories and Classification Pathways (2017) 

Mobile Medical Applications (2015) 

General Wellness: Policy for Low Risk Devices (2016) 

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (2015) 

Draft Clinical and Patient Decision Support Software (2017) 

Software as a Medical Device (SAMD): Clinical Evaluation (2017) 

Draft Multiple Function Device Products:  Policy and Considerations (2018) 

Content of Premarket Submission for Management of Cybersecurity in Medical Device (2014) 

Cybersecurity for Networked Medical Devices Containing Off-The Shelf (OTS) Software (2005) 

Postmarket Management of Cybersecurity in Medical Devices (2016) 

Design Considerations and Premarket Submission Recommendation for Interoperable Medical Devices (2017) 

Radio Frequency Wireless Technology in Medical Devices (2013)