Bill Overview
Title: BID Act of 2022
Description: 2022 This bill requires the Food and Drug Administration to report on the interoperability of medical devices, including associated standards, data, and costs.
Sponsors: Rep. Miller-Meeks, Mariannette [R-IA-2]
Target Audience
Population: People who use or are affected by medical devices subject to FDA standards
Estimated Size: 85000000
- The BID Act focuses on the interoperability of medical devices, which is particularly relevant to patients who use medical devices for monitoring or treatment purposes.
- Healthcare providers and administrators will be impacted as they need to understand and implement interoperability standards to improve patient care and system efficiency.
- Medical device manufacturers will need to adhere to the interoperability standards set forth and evaluated by the FDA, impacting how they design and update products.
- The act may influence health insurers and government programs that cover medical devices if it results in new guidelines affecting equipment coverage or reimbursement.
- Patients with chronic conditions or disabilities who rely on multiple interoperable devices are most directly impacted, as improved interoperability can enhance quality of care and user experience.
Reasoning
- The BID Act's primary impact will be on patients who use medical devices, healthcare providers, and medical device manufacturers.
- Patients using devices will benefit from increased interoperability, potentially improving their quality of life as devices become more integrated and easier to manage.
- Healthcare providers will need to implement and adapt to new interoperability standards, which can improve efficiency but also require initial investment and adaptation.
- Medical device manufacturers will face costs related to aligning with new standards but may also see benefits if improved interoperability increases market opportunities.
- The influence on health insurers and government programs will be indirect, coming from downstream impacts on device usage and patient outcomes.
Simulated Interviews
Retired nurse (Miami, FL)
Age: 65 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- I rely on my glucose monitor and insulin pump daily. More connectivity between devices would make managing my diabetes easier.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
Software developer for medical devices (San Francisco, CA)
Age: 40 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- It's challenging to meet new regulatory standards, but they're usually beneficial in the long run. This policy could push the industry forward.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Healthcare administrator (Chicago, IL)
Age: 55 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- Interoperability can streamline operations, but the transition phase can be costly and difficult.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
Medical device engineer (Portland, OR)
Age: 30 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- Meeting new standards is a technical challenge, but it drives innovation. I'm excited about what this could mean for future devices.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 8 |
Health insurance analyst (Boston, MA)
Age: 47 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- Improved device interoperability might change how we approach coverage, but it will take time to see these effects.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Retired teacher (Phoenix, AZ)
Age: 72 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- If my devices could communicate better, I'd feel more secure about my health management.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 9 | 5 |
Medical technician (New York, NY)
Age: 28 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- Standardizing devices could save time and improve patient care, but adapting quickly will be tough.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Physician (Kansas City, MO)
Age: 38 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- I think this will enhance patient care, but clinicians need proper training to adjust to new systems.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Regulatory affairs specialist (Atlanta, GA)
Age: 50 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Adhering to these standards is necessary, but it requires resources that not all companies may have.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Tech entrepreneur (Houston, TX)
Age: 62 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- This policy encourages innovation, which is great for tech entrepreneurs and investors.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Cost Estimates
Year 1: $20000000 (Low: $15000000, High: $25000000)
Year 2: $18000000 (Low: $13000000, High: $23000000)
Year 3: $16000000 (Low: $11000000, High: $21000000)
Year 5: $15000000 (Low: $10000000, High: $20000000)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- The FDA's capability and readiness to assess and report on the interoperability of medical devices.
- The capacity for device manufacturers to adapt to recommendations resulting from the bill.
- The potential for new regulatory standards to streamline device compliance internationally.