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 »
Developers and HIPAA
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 »
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 »
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?
A physician provides their patient with a medical device (like a CPAP or Glucose Meter). The company that created the medical device wants to monitor the maintenance of the machine. All of the information collected by the device that is sent to the physician is covered under a business associate agreement. Can the company that created the medical device receive information about the maintenance/operation of the device ...more »
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 »