Week 1 HW: Principles and Practices

HTGAA Week 1 – Class Assignment Student: Camarena Trujillo, Leonardo Joaquín

1. Biological engineering application

I would like to work on a portable, non-invasive glucose monitoring biosensor based on enzymatic detection. The idea is to use enzymes such as glucose oxidase to detect glucose levels from alternative body fluids like sweat or saliva, instead of traditional finger-prick blood tests.

Conventional glucose monitoring can be painful and inconvenient, especially for patients who need to test multiple times a day. Because of this, many people do not monitor their glucose regularly. A non-invasive and affordable device could make monitoring easier and more frequent, helping prevent long-term complications.

As a biomedical engineering student, I am interested in technologies that improve daily life for patients with chronic diseases. Diabetes is very common in many countries, including Peru, and access to continuous monitoring devices is still limited. A portable enzymatic biosensor could help improve adherence to treatment and overall quality of life.

2. Governance and policy goals

The main goal is to ensure that this technology is safe, reliable, and accessible, while also protecting patient data.

Sub-goals

• Protect patient data and privacy
• Ensure clinical accuracy and safety
• Promote equitable access

3. Governance actions

Option 1: Clinical validation before commercialization

Purpose:
Require proper clinical testing before the device enters the market.

Design:

• Approval by national health authorities
• Mandatory clinical trials

Assumptions:

• Regulators have enough resources
• Trials reflect real-world conditions

Risks:

• Higher development costs
• Slower innovation

Option 2: Strong data protection and user control

Purpose:
Protect sensitive health data collected by the biosensor.

Design:

• Encrypted data transmission
• Clear consent for data sharing
• User ownership of personal data

Assumptions:

• Companies comply with regulations
• Users understand consent options

Risks:

• Increased system complexity
• Higher development costs

Option 3: Public health subsidies for access

Purpose:
Make the biosensor accessible to more patients.

Design:

• Government or insurance subsidies
• Integration into public healthcare programs

Assumptions:

• Sufficient funding is available
• Distribution systems are effective

Risks:

• Budget limitations
• Unequal access in remote areas

4. Scoring governance options

5. Recommended strategy

I would prioritize a combination of Option 2 and Option 3.

Protecting patient data is essential, especially in continuous monitoring devices. At the same time, these technologies should be accessible to patients from different socioeconomic backgrounds. Public health programs and subsidies could help ensure broader access.

Option 1 is also important, but regulations should be balanced so they do not unnecessarily slow down innovation.

6. Ethical reflection

One important ethical concern is the handling of sensitive health data. Continuous monitoring systems generate large amounts of personal medical information, which could be misused if not properly protected.

Another issue is inequality. If non-invasive biosensors remain expensive, only certain populations will benefit from them, which could increase health disparities.

Possible governance actions:

• Strong data protection policies
• Transparent consent mechanisms
• Subsidies for low-income patients
• Integration into public healthcare systems