Bill Overview
Title: Strengthening Cybersecurity for Medical Devices Act
Description: This bill requires the Food and Drug Administration to regularly update its industry guidance and information for the public relating to the cybersecurity of medical devices. The Government Accountability Office must also report on cybersecurity challenges for medical devices, including older devices that may not support software updates.
Sponsors: Sen. Rosen, Jacky [D-NV]
Target Audience
Population: People who use or rely on medical devices
Estimated Size: 30000000
- Medical devices are widely used in healthcare systems globally, impacting patients who rely on these devices for treatment and monitoring.
- Healthcare providers and hospitals that use these medical devices will also be impacted as they need to ensure compliance with updated cybersecurity measures.
- Manufacturers and developers of medical devices will be significantly affected as they must address enhanced cybersecurity requirements and potentially redesign devices to comply.
- The cybersecurity community may also be impacted as they engage with new opportunities and challenges in protecting medical devices.
Reasoning
- Given the budget, it is crucial to focus on high-impact populations in terms of cybersecurity vulnerabilities. The policy will likely bring significant benefits to users of high-risk medical devices like pacemakers, insulin pumps, and other embedded devices.
- The population at risk particularly includes those with older medical devices, healthcare providers that haven't updated systems, and device manufacturers who need to incorporate new guidelines.
- Impact may vary: patients may feel more secure but also face temporary disruptions during transitions; healthcare providers may encounter initial costs but decreased long-term risks; manufacturers might face increased production costs, but gain in reputational terms.
- With an estimated 30 million targets, the goal is to show a comprehensive view through diverse interviews including commonly seen roles and less common situations to capture a range of impacts.
Simulated Interviews
Retired (Florida)
Age: 62 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- I'm glad they're focusing on keeping our devices secure. Any hack could be life-threatening.
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 | 9 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 5 |
Diabetic Educator (California)
Age: 45 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- This policy is crucial; there's always a risk with hacking, but it might increase device costs.
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 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 4 |
Software Engineer (Texas)
Age: 38 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 15/20
Statement of Opinion:
- It's a great opportunity for cybersecurity innovation but could delay device updates.
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 | 7 |
Retired Nurse (Ohio)
Age: 70 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- I worry about older device support, but it's good someone is checking on it.
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 | 4 |
| Year 10 | 8 | 4 |
| Year 20 | 8 | 3 |
Medical Device Sales Representative (New York)
Age: 29 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 12/20
Statement of Opinion:
- The changes are useful but could complicate my sales cycles due to extra compliance.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 5 |
Hospital IT Manager (Illinois)
Age: 60 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 9/20
Statement of Opinion:
- More secure devices are a priority, but policy compliance is a huge task. Immediate load but future relief.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 9 | 6 |
| Year 10 | 9 | 5 |
| Year 20 | 9 | 5 |
Medical Device Manufacturer (Massachusetts)
Age: 50 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- Security upgrades are necessary but costly; long-term benefit hopefully balances initial outlay.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 8 |
| Year 2 | 7 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 6 |
Health Policy Analyst (Washington)
Age: 34 | Gender: female
Wellbeing Before Policy: 9
Duration of Impact: 5.0 years
Commonness: 14/20
Statement of Opinion:
- Essential policy direction enhancing patient safety; provides data for better futures policies.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 9 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Patient Advocate (Colorado)
Age: 40 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 11/20
Statement of Opinion:
- Patients need reassurance that their devices are secure; this is a step in the right direction.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 9 | 4 |
Private Healthcare Provider (Georgia)
Age: 55 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 9/20
Statement of Opinion:
- Balancing costs with ensuring security will be challenging, but it's essential for patient trust.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 9 | 5 |
Cost Estimates
Year 1: $20000000 (Low: $15000000, High: $25000000)
Year 2: $21000000 (Low: $16000000, High: $26000000)
Year 3: $22000000 (Low: $17000000, High: $27000000)
Year 5: $24000000 (Low: $19000000, High: $29000000)
Year 10: $30000000 (Low: $25000000, High: $35000000)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- Balancing the costs of implementing robust cybersecurity measures against the potential high cost of cyber incidents due to vulnerabilities in medical devices.
- Coordinating among multiple federal agencies, such as the FDA and GAO, to ensure effective implementation.
- Engagement with stakeholders in the healthcare and manufacturing industries to facilitate compliance and adoption of updated cybersecurity measures.