Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Is all information created, received, or maintained on a health app subject to HIPAA? 1.31K viewsHospital and Healthcare 0 Votes 1 Ans If a health plan recommends that plan participants use a health app that provides wellness tools (for example, tracking the participant’s progress toward improving health), will use of the app trigger HIPAA compliance obligations? 1.46K viewsHospital and Healthcare 0 Votes 1 Ans Assume the same situation as in the previous question, except that health information is monitored by or provided directly to a third-party wellness vendor that uses data tracked in the health app to determine eligibility for certain incentives offered under an employer-sponsored wellness program. Is HIPAA compliance required? 1.35K viewsHospital and Healthcare 0 Votes 1 Ans From a HIPAA compliance perspective, is there a difference between the following two apps: (1) a health app offered in connection with a fully-insured group health plan that allows plan participants to request, download, and store health plan records and check the status of claims and coverage decisions; and (2) the direct-to-consumer version of this same app that allows individuals to store, manage, and organize their health records, improve their health habits, and send health information to providers? 1.38K viewsHospital and Healthcare 0 Votes 1 Ans What are the consequences of a breach of unsecured PHI involving the transfer of health plan-related data from the app developer to the group health plan? 1.47K viewsHospital and Healthcare 0 Votes 1 Ans Can I send out appointment reminder cards to my patients? How about reminder phone calls? 1.33K viewsHospital and Healthcare 0 Votes 1 Ans I treat patients in the emergency room, and it is very difficult to maintain patient privacy in that setting. What do I need to know about privacy in emergency situations? 1.30K viewsHospital and Healthcare 0 Votes 1 Ans What is meant by “incidental disclosures”? 1.39K viewsHospital and Healthcare 0 Votes 1 Ans How do I handle discussing the patient’s progress, test results, etc., with the patient when there are other people present? 1.57K viewsHospital and Healthcare 0 Votes 1 Ans I heard from someone that under HIPAA I will have to do away with patient sign-in logs in my clinic. Is this true? 1.67K viewsHospital and Healthcare 0 Votes 1 Ans What if you are treating a patient and want another professional’s advice? Can you say, “What would you do for (person’s name) if they had (whatever condition)? Can you have this discussion without the patient’s consent or awareness that it is happening? 1.26K viewsHospital and Healthcare 0 Votes 1 Ans Will ANDA goal dates be adjusted if a sponsor submits a Tier 2 unsolicited amendment in the period between FDA’s issuance of a CR letter and the sponsor’s submission of its CR response? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the consequences for failure to pay the DMF fee? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Will GDUFA goal dates apply if a facility identified in an ANDA fails to selfidentify during annual reporting period(s)? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the process for requesting a teleconference to clarify deficiencies and answer questions following FDA’s issuance of a CR letter? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Will FDA continue to accept applications in paper format? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans What does risk-adjusted parity mean? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans What is a fatal flaw? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans If a fatal flaw has not been identified, can the Agency issue a CR letter without inspections information? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans If a non-U.S. site is conducting a clinical investigation, are records required by FDA regulations subject to part 11 requirements? 1.52K viewsClinical Research « Previous 1 2 … 114 115 116 117 118 … 283 284 Next » Question and answer is powered by anspress.net
