Part 1:Critical Analysis of the Law

You are a senior compliance officer at a medical device company. The Director of Compliance has requested you review the following two articles:

(1) Innovation, Risk and Patient Empowerment/FDA Mandated Withdrawal of 23andMe

(2)FDA versus Personal Genetic Testing (https://www.newyorker.com/tech/annals-of-technology/the-f-d-a-vs-personal-genetic-testing)

1.Summarizing the FDA's activities concerning 23 and Me. What role does the FDA play?Why did it take this action?

2.How would this apply to future products or services you might develop?

Part 2: Strategic Application of the Law

You live in Shiprock, New Mexico - in what is called the Four Corners Region and hold a professional license to practice as a physician. You would like to open satellite offices and offer services in the neighboring states of Utah, Arizona, and Colorado.

1.What federal and state agencies will you need to contact? What is the role of state agencies in licensing?

2.Does it matter if you are an allopathic or osteopathic physician? Why or why not?

3.What actions would you need to take to practice in each of the states?

Links:

Additional Resources:

Federal Agencieshttps://www.hhs.gov/about/agencies/orgchart/index.html)

HHS:https://www.hhs.gov/about

CMS:https://www.cms.gov/

HHS OIG:https://oig.hhs.gov/

GAO Health Care:https://www.gao.gov/key_issues/overview#t=1

Office of Civil Rights (OCR):https://www.hhs.gov/ocr/index.html

FTC:https://www.ftc.gov/

FDA:https://www.fda.gov/

United States Sentencing Commission:https://www.ussc.gov/guidelines

US State Health Agencies:https://www.ehdp.com/links/us-shas.htm

US State Licensing and Certification Agencies:https://www.ehdp.com/links/us-shas.htm