CPHRM TEST QUESTIONS AND ANSWERS SET A+
✔✔Discuss when a covered entity may DENY a patient's request to access their own
PHI - ✔✔Most common scenarios an entity may deny access:
1. Psycho notes - if the request is for psychotherapy notes or mental health records,
2. Litigation - Information compiled or obtained in anticipation for litigation
3. Research - Information in a research study with treatment that is still in progress
4. Harm/jeopardize health and safety - Information may endanger the individual or
another person if obtained under a promise of confidentiality and would reveal the
source of the information.
Notice to patient of denial:
The patient must be notified in writing with the specific reason for the denial and how to
request a review or appeal.
Entities must have clear policies & procedures in place.
See Privacy rule 42 CFR 164.524.2
✔✔Outline requirements of Informed Consent in a research study - ✔✔Research -
Informed Consent requirements:
➣ A clear statement that the activity involves research.
➣ Research's purpose.
➣ A description of the procedures involved.
➣ Expected duration of the subject's participation.
➣ Foreseeable risks or discomforts.
➣ Any benefits to the subject or others that can reasonably be expected.
➣ Information on the confidentiality of records and how data might be used or de-
identified.
➣ A statement that participation is voluntary and the right to withdraw at any time.
➣ Contact information for questions about the research and the subject's rights.
Research informed consent regulation is primarily governed in the United States by the
Common Rule (45 CFR Part 46), which sets the federal standard for research involving
✔✔Discuss when a covered entity may DENY a patient's request to access their own
PHI - ✔✔Most common scenarios an entity may deny access:
1. Psycho notes - if the request is for psychotherapy notes or mental health records,
2. Litigation - Information compiled or obtained in anticipation for litigation
3. Research - Information in a research study with treatment that is still in progress
4. Harm/jeopardize health and safety - Information may endanger the individual or
another person if obtained under a promise of confidentiality and would reveal the
source of the information.
Notice to patient of denial:
The patient must be notified in writing with the specific reason for the denial and how to
request a review or appeal.
Entities must have clear policies & procedures in place.
See Privacy rule 42 CFR 164.524.2
✔✔Outline requirements of Informed Consent in a research study - ✔✔Research -
Informed Consent requirements:
➣ A clear statement that the activity involves research.
➣ Research's purpose.
➣ A description of the procedures involved.
➣ Expected duration of the subject's participation.
➣ Foreseeable risks or discomforts.
➣ Any benefits to the subject or others that can reasonably be expected.
➣ Information on the confidentiality of records and how data might be used or de-
identified.
➣ A statement that participation is voluntary and the right to withdraw at any time.
➣ Contact information for questions about the research and the subject's rights.
Research informed consent regulation is primarily governed in the United States by the
Common Rule (45 CFR Part 46), which sets the federal standard for research involving
