Bill Overview
Title: Medical Innovation Acceleration Act of 2022
Description: This bill exempts noninvasive diagnostic devices from the regulatory authority of the Food and Drug Administration. The bill defines noninvasive diagnostic device as one that does not penetrate the skin or any other membrane of the body, is not inserted or implanted into the body, causes no more than ephemeral compression or temperature changes to in situ bodily tissues, and does not subject bodily tissues to ionizing radiation.
Sponsors: Rep. Biggs, Andy [R-AZ-5]
Target Audience
Population: Individuals who utilize healthcare services that could involve noninvasive diagnostic devices
Estimated Size: 331000000
- Noninvasive diagnostic devices are commonly used in medical settings for both routine and specialized healthcare procedures, impacting a wide range of medical services.
- The legislation potentially affects both developers and end-users of medical technologies, including manufacturers, healthcare providers, and patients.
- As healthcare services are utilized worldwide, the impact of this legislation could be global. However, the direct impact on regulatory practices will be specific to the US market.
Reasoning
- The Medical Innovation Acceleration Act is expected to have varying impacts across different segments of the population. Its primary effect will be seen in how quickly noninvasive diagnostic devices can be brought to market, which will potentially benefit patients who need faster access to tests, as well as manufacturers who can innovate without waiting for FDA clearance.
- This policy might particularly impact people with chronic health issues, who frequently undergo medical testing, by improving their diagnostics speed and accessibility. Conversely, those without ongoing health concerns might not notice immediate changes.
- Given the high demand for healthcare services in the U.S., even minor modifications to regulatory processes can affect a large swath of the population. However, the degree to which this impact translates into wellbeing improvements depends on individual healthcare needs and how frequently people undergo diagnostics.
- The budget allocations imply a limited reach for initial years, perhaps focused on areas with an acute need for quick diagnostic access or involving major facilities adopting these technologies.
- Stakeholders not affected within the constraints of the budget might include those whose conditions do not require regular diagnostics, or those utilizing devices that fall outside the 'noninvasive' category.
Simulated Interviews
Primary Care Physician (New York, NY)
Age: 45 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 13/20
Statement of Opinion:
- This policy could streamline the process for adopting new diagnostic technologies in our hospital, ultimately benefiting patients with quicker, more efficient diagnostics.
- However, there are concerns about reduced regulatory oversight; the safety and efficacy of these devices should not be compromised.
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 |
Retired (Atlanta, GA)
Age: 67 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 12/20
Statement of Opinion:
- Faster access to diagnostic results due to these noninvasive devices could make managing my health conditions more convenient.
- I'm cautiously optimistic but concerned about insufficient oversight if not done right.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Software Engineer (San Francisco, CA)
Age: 28 | Gender: female
Wellbeing Before Policy: 9
Duration of Impact: 0.0 years
Commonness: 18/20
Statement of Opinion:
- This policy doesn't seem particularly relevant to me right now as I don't often require healthcare services.
- It might matter more if my circumstances change or for people around me who need frequent diagnostics.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 9 |
| Year 2 | 9 | 9 |
| Year 3 | 9 | 9 |
| Year 5 | 9 | 9 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
Healthcare Administrator (Dallas, TX)
Age: 53 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 14/20
Statement of Opinion:
- This policy could lead to cost savings and more efficient allocation of diagnostic resources, which are valuable in our operations.
- Reduced regulatory hurdles can spur quicker adoption but might pose challenges if devices are not thoroughly vetted.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Biomedical Engineer (Chicago, IL)
Age: 36 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 10/20
Statement of Opinion:
- This policy is exciting for us as it means fewer delays in bringing innovative devices to market.
- I hope this will stimulate more investment in noninvasive diagnostics.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Retired Nurse (Miami, FL)
Age: 70 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 15/20
Statement of Opinion:
- I'm hopeful that this policy might mean less hassle with follow-up diagnostics post-surgery.
- However, assurance of device safety and effective outcomes is crucial and should not be compromised.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
College Student (Boston, MA)
Age: 22 | Gender: male
Wellbeing Before Policy: 9
Duration of Impact: 5.0 years
Commonness: 17/20
Statement of Opinion:
- I don't think this policy affects me much right now, but it's interesting to see how diagnostics might change when I enter the professional world.
- My interest in technology aligns with developments in medical devices.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 9 |
| Year 2 | 9 | 9 |
| Year 3 | 9 | 9 |
| Year 5 | 9 | 9 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
Public Health Researcher (Seattle, WA)
Age: 39 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- This policy could be a double-edged sword: potential for innovation versus risk of inadequate safety assessments.
- Public health must take precedence even while encouraging innovation.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Small Business Owner (Phoenix, AZ)
Age: 53 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 0.0 years
Commonness: 16/20
Statement of Opinion:
- I don't think this policy impacts my day-to-day life at all.
- It's more relevant to those actively engaging with healthcare services.
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 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Tech Entrepreneur (Portland, OR)
Age: 31 | Gender: male
Wellbeing Before Policy: 9
Duration of Impact: 20.0 years
Commonness: 10/20
Statement of Opinion:
- This policy presents new business opportunities by paving the way for innovative health solutions to be more easily developed and deployed.
- Remaining conscious of privacy and safety standards is crucial.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 9 |
| Year 2 | 9 | 9 |
| Year 3 | 9 | 9 |
| Year 5 | 9 | 9 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
Cost Estimates
Year 1: $50000000 (Low: $40000000, High: $60000000)
Year 2: $50000000 (Low: $40000000, High: $60000000)
Year 3: $55000000 (Low: $45000000, High: $65000000)
Year 5: $60000000 (Low: $50000000, High: $70000000)
Year 10: $70000000 (Low: $60000000, High: $80000000)
Year 100: $150000000 (Low: $120000000, High: $180000000)
Key Considerations
- The bill's impact depends heavily on how extensively noninvasive diagnostic devices are adopted following deregulation.
- The assumed increase in device sales might be constrained by market saturation or competing technologies.
- The bill could set a precedent for deregulation in other medical technology areas, with broader implications.