Developers need better guidance around patient generated health data, since HIPAA focusses on one-way data sharing from a provider/other covered entity outward to the patient/other entity. In the future, more and more data will be flowing in the opposite direction, and there should be guidance to clarify that HIPAA should not prevent the flow of information from the patient back to the provider.
There is a lack of transparency around the content of Business Associate Agreements (BAAs), a lack of sample BAA language around the topics developers care about, such as cloud storage & PGHD, and a lack of bargaining power on the part of startups. This has led to many challenges for the industry, resulting in high legal fees which may be a barrier to entry for many companies. HHS should issue sample BAA language around... more »
Does the entire environment need to be HIPAA compliant, or is it possible that the solution could fall into an exception to HIPAA, or can they use an API to store certain kinds of data? If you’re building modern technologies, you’re relying on a lot of third party (likely API) based services; mostly cloud based services. So which aspects of those need to be compliant?
How can we determine if we’re a covered entity? The resources to make that determination are expensive – i.e. law firms
With random audits becoming a feature of HIPAA enforcement, small companies and Business Associates should ensure that information sought by OCR is readily available. This will allow OCR to make assessments quickly and efficiently. Making this process efficient also limits the disruptive impact audits can have on emerging companies. Similar to the practice of the FCC, can OCR provide guidance for Business Associates regarding... more »
What are the suggested encryption protocols that one should implement in order to fulfill the 164.312(a)(2)(iv)
Have you implemented a mechanism to encrypt and decrypt EPHI?
Right now, developers expend a lot of time and resources (including the cost of data storage) on audit logging but don’t have assurance that they are in compliance. Could HHS provide an open source library of code to help developers understand how to execute audit logging.
I would like to know if I offer an online appointment scheduler to health care providers, would the system and I, as the programmer/manager need to abide by HIPAA or other related laws. Information included in the system would not be medical in nature; it would just be the clients name, appointment date and time, their email address and phone number. Possibly a credit card for deposits, but that's not the concern. The... more »
Remote devices may not have access to the internet at all times and therefore may be operating offline. Data must be stored on the devices until connectivity is restored. What is the protocol for PHI data storage on offline mobile devices?
Developers need better guidance around cloud storage/computing and the Security Rule. Client-server architecture is no longer relevant in many cases. Health technology companies are typically now 100 percent cloud-based. Many clients are doing some type of data analytics work, or offer cloud-based EHRs and medical devices. HHS should provide good guidance for companies that are cloud based and virtual. Most companies... more »
Is there any limitation on a covered entity's de-identification of PHI or use of de-identified information? For example, may a covered entity de-identify information purely for the purposes of selling data as a service? Additionally, from a Privacy Rule perspective (i.e., not considering state law or contractual considerations), are there any restrictions on a business associate using or disclosing the de-identified... more »
Employees of a Business Associate must be trained on the basics of HIPAA. Startups and emerging companies want to ensure that the training their employees receive meets the standards expected by OCR. Similar to the practices of OSHA, can OCR provide a standardized training program on key HIPAA issues?
Small companies and Business Associates are eager to meet their security requirements under HIPAA. Many smaller B.A.s have stated that they are unable to use the current security risk assessment tool because they believe it is needlessly cumbersome, redundant, and designed for Covered Entities. Do you recommend that Business Associates start to use private tools instead of the current tool for risk assessments? If so,... more »
We are not a covered entity or business associate. We are developing a direct-to-consumer app that tracks medication adherence. We want to de-identify the information the app collects to sell to third parties. Do we follow the same HIPAA de-identification processes that a covered entity or business associate would follow?
In order to be HIPAA compliant, should all activity that occurs with in an app be logged, or should activity that exceeds the normal threshold be logged? For instance, users that access information in the application routinely during the course of their work day will evince a regular level of activity. The activity will indicate routine access of sensitive information. Should the log contain all of the users activity,... more »