Reference no: EM132920706

1. Explain what a security control is and give 2 examples from a healthcare environment

2. How are medical devices regulated in the U.S.? Explain the three classes

3. Diabetic patients need continuous blood sugar monitoring. Explain how technology can be used to support that in a safe manner.

4. Explain the difference between PHI and PII and give 2 examples of each.

5. NIST 1800-300 discusses the concept of an HDO in Telehealth security. Describe the HDO in your own words.

6. You are asked to do a risk assessment for a new implantable medical device to be used by your doctors. What facts would you consider in the risk assessment?

7. Discuss your viewpoint of the possibilities of technology such as implantable medical devices improving disease control.

8. Describe the relationship between security and privacy for medical devices

9. What is the 510(k) and what types of medical devices does it cover?

10. Describe the 3 characteristics of the CIA triangle and give an example from the healthcare field when using medical devices

ISO14971:2019 is a standard for the application of risk management to medical devices. The standard itself is an expensive document but there are several web sites that give information on its contents and use.

Write a memoto the Chief Medical Officer, so minimize jargon, on why adoption of this standard is in the best interest of the large hospital where you are the CIO. Explain what it contains and why it should be valuable to maintaining the security and privacy associated with the increasing use of medical devices. Provide at least 3 citations for your memo.