Frequently Asked Questions
What is the Medical Device Information and Analysis Sharing (MDIAS) initiative?
MDIAS is a voluntary Public-Private partnership between the Food and Drug Administration (FDA) and the private sector in the medical device ecosystem. This partnership analyzes broad and extensive medical device data to enable data-driven intervention strategies aimed at improving medical device quality and healthcare outcomes. The concept stems from the recognition that data from a wide variety of sources can provide greater insights than data from a single source. MDIAS fuses various healthcare data sources to proactively identify quality and safety trends and to assess the impact of changes in the medical device ecosystem. Data is safeguarded by an independent and Trusted Third Party, The MITRE Corporation (MITRE), to foster broad participation and engagement.
Who Participates in MDIAS?
MDIAS Partners currently represent a subsection of the medical device ecosystem, including device manufacturers, a healthcare provider organization, and the FDA. In the future, MDIAS will bring on more partners, such as additional device manufacturers and healthcare provider organizations, patients and/or patient advocates, payers, and universities.
What makes MDIAS unique?
MDIAS can uniquely serve the medical device ecosystem by enabling:
- Safe collaboration between industry and government: MDIAS aims to facilitate data aggregation, analysis, and synthesis between device manufacturers, healthcare providers, patients, payers, trade associations, universities, and government. MDIAS Partners will be able to explore this synthesized data in a collaborative, sanction-free, non-competitive environment to accelerate problem-solving needed to improve device quality and patient safety.
- Secure stewardship of protected data: MDIAS offers medical device stakeholders an opportunity to share data that has been historically siloed and therefore insufficient to provide a systemic view. Non-public data that is shared with the Trusted Third Party will be ingested, de-identified, analyzed, and aggregated using strict data management protocols so MDIAS Partners can be confident of their data security.
- Objective and systemic analysis of data: MDIAS will provide greater insights than the analysis of data from a single source. By aggregating data from across the medical device ecosystem, MDIAS’ independent and systemic analyses can identify new trends and quality risks that no individual organization would be able to learn on their own. MDIAS Partners will also be able to compare their organization’s data with the aggregated data and eventually against industry benchmarks.
How does MDIAS fit in the Case for Quality Collaborative Community?
MDIAS operates as an initiative within the Case for Quality (CfQ) Collaborative Community (CfQcc) to achieve the CfQ mission in enhancing medical device quality and patient safety. MDIAS provides periodic updates to the CfQ Steering Committee.
What is the MDIAS Proof of Concept?
The MDIAS Proof of Concept (POC) phase enables stakeholders to work collaboratively together and with the Trusted Third Party to explore how the MDIAS partnership model could operate and whether it could advance device quality and patient safety. The objectives of the POC are to build trust among stakeholders, enable collaborative decision-making, and achieve tangible results that demonstrate the value of the partnership.
How can I contact MDIAS?
For more information or to contact someone at MDIAS, email email@example.com.
Roles and Responsibilities
Who is MITRE and what is their role in MDIAS?
MITRE is a not-for-profit, private corporation chartered to work in the public interest. MITRE supports a broad and diverse set of civilian and defense agencies through its management of federally funded research and development centers (FFRDCs).
MITRE acts in the role as the Trusted Third Party (TTP) for MDIAS. In this role, MITRE serves as an independent facilitator of industry, data steward, and data analyst. As an independent facilitator, MITRE brings stakeholders together to achieve shared goals that could not be achieved by operating independently. As a data steward, MITRE maintains the security and anonymity of the data provided. As the data analyst, MITRE conducts the analysis and facilitate stakeholder interpretation and validation of the results. Having the TTP serve as the data analyst means that raw data can only be viewed by the TTP, and the results are always de-identified to protect the identity of partner organizations.
What is the FDA’s role in MDIAS?
MDIAS is a Food and Drug Administration (FDA)-funded program at present. However, the FDA is an equal partner with industry and adheres to all MDIAS policies and procedures. FDA participates on the MDIAS Governing Committee with other industry representatives and will provide data for MDIAS studies. Like industry, FDA will not be able to see non-public data shared with the Trusted Third Party.
How is MDIAS governed?
MDIAS is governed by a MDIAS Governing Committee (GC), which is comprised of representation from:
- Large and Small Medical Device Manufacturer
- A Healthcare Organization
- FDA’s Center for Devices and Radiological Health
This group provides oversight and makes key decisions regarding the MDIAS program. The GC is also comprised of two strategic advisors to aid in oversight of MDIAS.
Data Sharing and Protection
How will my organization’s data be protected?
MITRE routinely stores sensitive data for many governmental and industry sources as part of its public interest role. MITRE employs secure, encrypted data feeds, strictly limits access to data, stores all the data on a private network not connected to the Internet, and employs secure firewalls with traffic monitoring, intrusion detection systems, log monitoring, and user audits. MITRE – as the Trusted Third Party – and Early Adopters have co-created a data management plan (DMP) that outlines how data will be managed throughout the MDIAS data lifecycle. The DMP defines the policies and procedures for security controls, storage, access, privacy, regularly scheduled audits, and sharing of findings/results to clarify how data and results will be safeguarded and protected.
How does my organization provide data to MDIAS?
The Trusted Third Party (TTP) will meet with your organization to discuss the data sharing agreement process. A cooperative agreement template will be used by the TTP to formalize partnership and enable non-public data sharing with MDIAS.
What is the MDIAS Collaboration site?
The MDIAS Collaboration site is an online shared space, where MDIAS Early Adopters can access and review non-public content and documents. The MDIAS Collaboration site is hosted by the Trusted Third Party (TTP) and only MDIAS Early Adopters and the TTP can access information on the site.
Can I see a list of organizations participating in MDIAS today?
The organizations participating in MDIAS are shared on the MDIAS Community page of the MDIAS website. This page will continually be updated as new organizations join the partnership.
What does it cost to participate in MDIAS?
Currently, there is no cost to participate in MDIAS. However, an organization will need to sign key documents to formalize its participation in MDIAS, including the MDIAS Program Charter and the Cooperative Agreement.
How does an organization formalize its participation in MDIAS?
There are two key documents that need to be signed to formalize participation in MDIAS: the Program Charter and the Cooperative Agreement. The Program Charter specifies MDIAS’ guiding principles, outlines roles and responsibilities of partners, the Governing Committee, and the Trusted Third Party (TTP), and establishes the binding rules for the operation of MDIAS. The Cooperative Agreement is a legal document enabling stakeholders to share data with the TTP.
What are my commitments once I join MDIAS?
Once an organization joins MDIAS, the organization must adhere to all MDIAS policies and procedures as outlined in the MDIAS Program Charter and the Cooperative Agreement. Representatives from the organization may choose to participate in one or more working groups to collaborate with other MDIAS Partners.
What benefits will my organization receive from participating in MDIAS?
MITRE will work initially with the FDA and medical device manufacturers to explore the possibilities for incentives that will help to address industry pain points related to regulatory compliance. As MDIAS participation expands to include providers, payers and other stakeholders within the medical device ecosystem, MITRE will engage with relevant regulatory bodies to explore additional opportunities for creating incentives.