BMI2207C CA1

Question 1

List the 4 objectives of EMRAM (4S).

Answer 1

1. Improving patient SAFETY
2. Increasing patient SATISFACTION
3. SUPPORTING clinicians
4. SECURING data

Question 2

Explain what EMRAM stands for and what it is about.

Answer 2

EMRAM stands for Electronic Medical Record Adoption Model and is by the Healthcare Information and Management System Society (HIMSS). It is a scoring system that incorporates methodology and algorithms that hospitals can follow for digitalisation.

Question 3

Why is digitalisation important?

Answer 3

1. Greater efficiency
2. Reduced human errors
3. Greater accessibility
4. Facilitates integration at the system level
5. Enables continuity of care for same patient at different hospitals
6. Facilitates data analytics for clinical decisions
7. Improves security and privacy
8. Allows patient to view and access

Question 4

What does ETL stand for?

Answer 4

Extract
Transform
Load

Question 5

What is ETL for?

Answer 5

• Ensures operating systems are kept lean and functional
• Ensures data is effectively integrated and managed

Question 6

Explain extraction.

Answer 6

Retrieving data from multiple sources. This is because data might be REPEATED in different databases and data might have different variations in different databases.

Question 7

Explain transform.

Answer 7

Transforming the extracted data to ensure consistency and accuracy.
- Involves data standardisation to ensure that transformed data is compatible with the data in the database
- Challenging to match data from disparate, heterogeneous sources

Question 8

Explain some important features of ETL systems.

Answer 8

1. Ensures data integrity
2. Retains flexibility to turn raw data into info that you can work with
3. Scalable architecture
4. Requires standardised data

Question 9

How do clinicians use ETL?

Answer 9

1. Convert patient data from subsystems like EHR and EMR to allow interoperability
2. Downstream analytics and AI operations
3. Support clinical decisions
4. Create algorithms for diagnostic tools and research

Question 10

Define Healthcare data.

Answer 10

Any data related to :
- Health conditions
- Reproductive outcomes
- Causes of death
- Quality of life
for an individual or population

Question 11

Distinguish between primary and secondary healthcare data.

Answer 11

Primary healthcare datasets are data elements that are collected for each patient encounter in a particular healthcare setting.
Secondary healthcare datasets are aggregates of data across multiple encounters.

Question 12

Explain how healthcare data can be categorised.

Answer 12

Categorised based on difference in level of organisation (structured, unstructured, semi-structured)

Question 13

Big data is defined by the 3Vs :

Answer 13

Volume, Velocity, Variety

Question 14

Big data varies in :

Answer 14

Features, Sources, States

Question 15

Distinguish between data, information and knowledge.

Answer 15

• Data consists of raw facts
• Information consists of a collection of facts organised and processed to provide answers to specific questions
• Knowledge consists of awareness and understanding of a set of information
  Finding relationships among data would help to turn data into information and then knowledge.

Question 16

Explain what is a patent.

Answer 16

• A right granted to you by a government institution for a period of time
• This right is granted in exchange for full disclosure of the invention
• This right gives you the ability to exclude others from making, using, selling or importing the claimed invention into the issuing territory

Question 17

Explain the criteria for filing a patent?

Answer 17

1. Utility (Is it useful?)
2. Novelty (Is it really new?)
3. Non-obviousness (Is your idea really a significant step forward?)
4. Reduction to practice

Question 18

Explain reduction to practice

Answer 18

Cannot gatekeep the first best practice and release the second best practice. Have to release first best practice.

Question 19

Distinguish between provisional VS non-provisional patents. [Timeline, Validity, Cost, Format, Review, Publication]

Answer 19

Provisional patent :
- Can be filed in hours by inventors themselves but more extensive provisional disclosure is preferred
- Valid for 12 months
- Cost $140 for small entity
- Format : Any text and drawings, claims are not required
- Review : Not examined by the USPTO
- Publication : Not published by USPTO unless a non-provisional application claims priority

Question 20

Explain the regulation scope of FDA.

Answer 20

• Protects public health by evaluating the safety and effectiveness of medical products
• FDA legal authority is limited to regulating commerce of medical devices, drugs and biologics
• No jurisdiction over practice of medicine
• Jurisdiction over manufacturing companies : Not allowed to promote their products beyond the uses for which they are approved by the FDA
• FDA does not take cost or cost effectiveness into consideration in evaluation
• FDA does not take patentability into consideration

Question 21

Explain FDA Risk Categorisation

Answer 21

Class 1 :
- Low risk, General controls
- Eg : Tongue depressor, mechanical wheelchair
Class 2 :
- Moderate risk, General-Special controls
- Eg : Mercury thermometer, Powered wheelchair
Class 3 :
- High risk, General controls, Premarket approval
- Eg : Coronary stent, Deep brain stimulation

Question 22

List the 3 regulatory pathways

Answer 22

1. Exempt devices
2. 510 (k) Pre-market Notification
3. Premarket Approval (PMA)

Relationship between classes and pathway is not 1 to 1

Question 23

Explain the exempt devices pathway.

Question 24

Explain 510(K) Pathway.

Question 25

Explain De Novo pathway.