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 »
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 »
Our EHR solution is partnering with another health related software company with a cloud based API product to provide additional solutions for providers. This is a seamless connection. Some PHI would be stored on the API cloud based system while our EHR would also store PHI either on the client server or the cloud. I have several questions. I am assuming that the business associate between our clients/providers... 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 »
From Kevin Wiggins, Saul Ewing: If a CE puts PHI on the Cloud and later terminates that Cloud as a service provider, there is inevitably some data remanence, thus leaving PHI on the Cloud. NIST Special Publication 800-80 addresses this by suggesting CEs use crypto-erase. What if the CE previously sent unencrypted PHI to the Cloud? Is it as simple as extending the protections of the contract to the information and... more »
If a company has a business associate agreement (BAA) with an electronic medical record (EMR) vendor, does that company also have to sign a BAA with each health care provider or provider group using that EMR in addition to their existing BAA with the vendor?