Business Associate Agreement Research Purposes

What is an « associate »? `counterparty` means any natural or legal person who performs certain functions or activities involving the use or disclosure of protected health information on behalf of an undertaking concerned or the services provided to that undertaking. A staff member of the covered company is not a business partner. An insured health care provider, health plan or health care clearing house may be a counterparty to another covered entity. The data protection rule lists certain functions or activities as well as the respective services that make a natural or legal person a counterparty when the activity or service involves the use or disclosure of protected health information. The types of functions or activities that may make a natural or legal person a counterparty include payment or health activities, as well as other functions or activities governed by the administrative simplification rules. Because HIPAA concepts are difficult to translate into international studies, researchers have several possibilities. The first is to ask the IRB to approve a simpler form of the required authorization language, either in the main part of the written consent itself, or separately as a separate form [« HIPAA Statement for International Research »], and/or to seek permission to obtain the authorization orally. Another option, in which cultural barriers are significant, is to seek permission to exclude HIPAA language from the declaration of consent and consent process. This may be most appropriate if the data is not transferred to the United States and is protected by the HIPC. Question 1: In accordance with HIPAA rules, we must keep a record of all persons who have accessed PHI in our database in order to provide a list of disclosures if and when a participant requires it. Every time a member of our research team looks at the data, do we have to record a new entry or do we just have to enter a new entry into the protocol if someone outside the team is looking at the data? Question 1: Do HIPAA requirements allow participants to request a copy of all structured interviews they concluded/responded to as part of the study? What about the results of research laboratory tests? (A) For the sound management and management of the counterparty; . Be aware that this is not a defined area of the law. Different experts have different opinions.

But until there is further clarification, that is our position on this issue. Contact OHSR for specific requests to provide copies of research papers or information to non-Hopkins entities. Data aggregation means, in respect of protected health information produced or received by a counterparty in its capacity as counterparty to a covered undertaking, the combination of such health information protected by the counterparty and protected health information received by the counterparty in its capacity as counterparty to another relevant undertaking, in order to allow data analysis: refer to the health operations of the undertakings concerned concerned. Answer: No. Any form of written agreement obtained before 14.04.2003 « paper » the data collected before that date in the search database. . . .