Bill Overview
Title: PATCH Act
Description: This bill requires premarket applications for cyber devices (i.e., medical devices that include software or connect to the internet) to include information relating to cybersecurity, including plans to monitor for cybersecurity risks and address vulnerabilities through regular product updates.
Sponsors: Sen. Cassidy, Bill [R-LA]
Target Audience
Population: People reliant on cyber medical devices
Estimated Size: 25000000
- The bill impacts manufacturers and developers of medical devices that include software or connect to the internet, as they will need to comply with new regulations.
- Healthcare providers who use these cyber devices will be affected because device cybersecurity impacts patient safety and the functionality of the devices.
- Patients who rely on medical devices connected to the internet may be affected in terms of the safety, security, and reliability of these devices.
- Regulatory bodies and hospitals must ensure compliance with the cybersecurity measures outlined in the bill.
Reasoning
- The PATCH Act primarily affects manufacturers and developers of medical devices, and indirectly impacts healthcare providers and patients who are dependent on internet-connected medical devices.
- Given the budget constraints, a large-scale public awareness campaign or major infrastructural changes in hospitals beyond what's needed for compliance aren't feasible.
- Focus will be on enhanced cybersecurity protocols that would largely benefit users of these devices by potentially increasing their trust and wellbeing associated with device usage.
- The population also includes a subset of healthcare professionals responsible for implementing these cybersecure measures, but their direct wellbeing isn't the focus unless tied to device reliability and patient safety.
- The overall impact on people's wellbeing depends on the degree to which they interact with these 'cyber devices' in their everyday life.
Simulated Interviews
Biomedical Engineer (California)
Age: 45 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- I believe the PATCH Act will help standardize our cybersecurity efforts, potentially reducing our costs in the long term.
- It might initially increase the workload, but consistency in requirements helps in maintaining robust systems.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Patient (Texas)
Age: 60 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- I'm a bit concerned about vulnerabilities in my insulin pump, so more updates and monitoring would be reassuring.
- As long as updates don't disrupt the functionality, I'm in favor.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 4 |
Nurse (Illinois)
Age: 37 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- Knowing that devices are more secure gives me peace of mind when dealing with patients.
- It's one less thing to worry about during my shifts.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 5 |
Hospital IT Specialist (New York)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- This bill makes my job more challenging but also more important than ever.
- We'll need better resources to manage the updates efficiently.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 6 |
Software developer for medical devices (Florida)
Age: 30 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 2/20
Statement of Opinion:
- This policy aligns with where the industry should already be headed.
- Standardization helps us create better products.
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 | 9 | 6 |
Patient (Ohio)
Age: 34 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- Cybersecurity is a big concern for me—any breach could be life-threatening.
- I'd feel safer knowing there are regular, reliable updates.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 7 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 4 |
Policy Analyst (Washington)
Age: 28 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 4/20
Statement of Opinion:
- It's a step in the right direction for patient safety.
- Implementation will likely face challenges but is necessary.
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 | 7 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 5 |
Caregiver (Michigan)
Age: 41 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- Anything that improves device security is good for my patients.
- I'm concerned about how quickly these updates can be integrated without disruption.
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 | 4 |
| Year 20 | 6 | 4 |
Retiree (Arizona)
Age: 55 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- I'm only recently becoming aware of cybersecurity issues with devices.
- Ongoing updates would help me feel more secure.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 4 |
Health tech startup founder (Georgia)
Age: 29 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 2/20
Statement of Opinion:
- The PATCH Act presents both challenges and opportunities for innovation.
- Compliance raises the bar for new entrants in the field but improves user trust.
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 | 6 |
| Year 20 | 8 | 6 |
Cost Estimates
Year 1: $2000000000 (Low: $1500000000, High: $2500000000)
Year 2: $1800000000 (Low: $1400000000, High: $2200000000)
Year 3: $1600000000 (Low: $1300000000, High: $1900000000)
Year 5: $1400000000 (Low: $1100000000, High: $1700000000)
Year 10: $1000000000 (Low: $800000000, High: $1200000000)
Year 100: $200000000 (Low: $100000000, High: $300000000)
Key Considerations
- Long-term benefits of enhanced cybersecurity in medical devices could outweigh initial costs in terms of societal and economic impact.
- Compliance costs could strain smaller manufacturers disproportionately compared to larger firms.