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.
Developers and HIPAA
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 »
There is currently a lack of clarity about whether patient consent to communicate via (unencrypted) SMS is adequate to protect covered entities from HIPAA concerns. HHS (and medical research) has released data supported use of non-encrypted SMS, given its high accessibility to patients and its efficacy in achieving behavior change (e.g. medication compliance, smoking cessation). Many covered entitites feel that this ...more »
The topic came up in a planning session around the point in time when a PR becomes a PR. Let's say we are writing an app for first responders. If the user collects name, date of birth, and vital signs. Does the PR become legally protected as soon as the First name is collected, or is there some threshold of data size(fields, values, etc.) that indicates that the PR has been created in legal terms for HIPPA protection? ...more »
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 »
We make medical devices and sell to CEs through a independent sales team/resellers. Often times where there are some issues with software that runs on devices -- the reseller obtains the corresponding record from CE and uploads to our Customer Support portal. This ticket can contain medical health information. As a device manufacturer are we required to adhere to HIPAA? We may get a few hundred such tickets from different ...more »
I am looking to find a HIPAA regulation that tells me whether or not a healthcare facility needs to have all TIA/EIA-568-B certified data cables. I know this would fall under data integrity, but I cannot find where in HIPAA that it states that best practice or industry standards must be met.
We have a question regarding a vendor that claims that they don't need a BAA as they are a "conduit" and are exception. Is there someone at the OCR that could help us adjudicate this problem?
As a software developer in the role of business associate I have read about what needs to be captured and stored by software that handles PHI for a covered entity. To be a good vendor, we want to provide our customer the requisite log data about user credentialing (adds, permissions, changes, disables, deletes), and about PHI activity within our software product. We currently log all changes to PHI made by our product. ...more »
Does OCR recommend any guides to developers to help them evaluate different kinds of cyberinsurance policies and to determine what types and levels of insurance are needed depending on the application they have developed and for general company compliance?
How can we determine if we’re a covered entity? The resources to make that determination are expensive – i.e. law firms
I understand there is some ambiguity regarding providers communicating PHI with patients, and I'm having some trouble interpreting how it applies to me. My provider developed software to engage patients via unencrypted SMS. My provider's medical practitioners will determine a patient is in need of monitoring and will develop or reuse a workflows to regularly request defined PHI from patients--such as diastolic and systolic ...more »
I am a compliance consultant, seeing an increasing amount of concern from cloud service providers about customers/users sharing PHI via their platforms in clear violation of Terms of Service. (Depending on the platform, customers/users range from individuals to business associates to covered entities.) Specifically, the CSPs are concerned about whether allowing accounts in violation to remain active is somehow tacit acceptance ...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?
If my provider is communicating PHI and non-PHI with patients through a 3rd party SMS service, such as Twilio, would my provider be required to sign a BAA with an SMS service company or such a company be classified as a conduit? We are sending encrypted data to the SMS service which is then sending unencrypted SMSs to patients. Patients can then potentially respond to those SMSs via unencrypted SMS which would be directed ...more »