patient meets with doctor remotely

White Paper

Modernizing Medicare Coverage for Digital Health Technologies

AdvaMed has issued a white paper detailing recommendations for modernizing Medicare coverage and payment policies so that beneficiaries can have greater access to the latest digital health innovations.

data dashboard on digital tablet by stethoscope

Privacy Principles

AdvaMed U.S. Health Data Privacy Principles

The collection, sharing and use of health information is fundamental to advancing health care. AdvaMed member companies take seriously their obligation to ensure the appropriate use and privacy of personal health data and have endorsed principles for U.S. data privacy policy.

The AdvaMed Center for Digital Health 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, the Center for Digital Health 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. 

Center for Digital Health 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 Center for Digital Health members and interested stakeholders and we welcome your outreach and feedback at [email protected]amed.org

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. 

Center for Digital Health 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.  

healthcare professional conduct a meeting

Network

Members of the Center for Digital Health

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

Center for Digital Health Policy  

The Center for Digital Health 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)