HIPAA - Juris week 4

when should pharmacies comply w/ HIPAA?

• pt info = electronic

• billing = electronic

• disclose minimum necessary PHI medication info

• must obtain written acknowledgement of privacy practices (distribute a notice)

• select a compliance officer

• training employees on regulations

• BAA: business associate agreements

At what age do you start being covered by HIPAA?

18 years old

What conditions allow someone to be covered by HIPAA younger than 18 y/o?

-minor consents to care

-consent of parents not required under State or applicable law

-minor obtains care at direction of court

-parent agree minor and HCP can have a confidential relationship

-emancipated

-imminent harm

T or F: Patients have the right to restrict PHI disclosures (i.e. RPh has the right to restrict who picks up Rx’s at the pharmacy)

T

HIPAA states the signed patient acknowledgement must be retained for?

A. 1 yr

B. 6 yrs

C.

6 years

How long do your HIPAA rights last after death?

A. 5 yrs

B. 10 yrs

C. 20 yrs

D. 50 yrs

50 yrs

who gets sent HIPAA breach notifications?

-affected indiv.’s

-secretary of dept of health and human services (portal)

-media

if breach affecting < 500 indiv.’s, entity must notify Secretary of breach within ___________

60 days of the end of the calendar year

f breach affecting > 500 indiv.’s, entity must notify Secretary of breach no later than ___________

60 calendar days from discovery

HIPAA also provides _____ provisions

security

C. Food and Drug Administration Modernization Act of 1997 (FDAMA)

FDAMA initiatives include

-inc. pt access to promising drugs and medical devices

-expanded database on clinical trials will be accessible by patients

B. <795> and <797>

What was the Prescription Drug User Fee under FDAMA?

Industry provides funding, in return FDA agreement to meet drug-review performance goals

What does the Off-Label Medication Uses (Guidance) entail under FDAMA?

Allows manufactures share peer-reviewed journal articles about an off-label indication of its product