- carlygoldAsked on August 27, 2013 at 08:26 PM
HIPAA/Hitech have had some revisions as of Jan 25 2013 and any company that receives or stores protected health information IS a business associate- regardless of whether they have signed an agreement or not. The interpretation by many experts is that such a company would be at risk for fines if not following the regulations and standards. See the excerpts below:
Business Associate Definition Scope Expansion
The Rules clarify the circumstances in which vendors are deemed to be Business Associates, and expand the definition of “Business Associate” to include most subcontractors that access PHI.
The Rules clarify that vendors that require “routine” or “more than random” access to PHI are Business Associates, while those that act as “mere conduits” for or have “random access” to PHI continue to be outside the scope of the definition. This distinction is not based on whether a vendor or a subcontractor has an “opportunity” to access the data, but rather on whether that opportunity is “transient” or “persistent,” with persistent opportunity more likely to deem a vendor a Business Associate. While entities that are “mere conduits” for PHI are not Business Associates, the Rules emphasize that this exception is narrow. It is limited to entities providing data transmission services, including services that involve temporary storage of PHI that is incident to the transmission, i.e., courier services and their electronic equivalents, such as ISPs or telecoms.
For those looking for clarity, the HHS notes that the determination of whether access to PHI is “routine” or “more than random” is fact-specific, based on (1) the nature of the services and (2) the extent to which the vendor needs access to the PHI to perform the services. The HHS expects to issue additional guidance on the types of entities that are and are not Business Associate under the Rules.
Examples of vendors that are likely to be deemed Business Associates include:Providers of data transmission services, to the extent they require “routine access” to the PHI; Data storage or document storage vendors – whether or not they view the PHI they maintain; Operators of portals or other interfaces created on behalf of covered entities that allow patients to share their data with the covered entity;
Importantly, the Final Rule reaffirms that regardless of whether a business associate agreement exists, one is deemed to be a business associate from the moment that person or entity creates, receives, maintains, or transmits PHI on behalf of a covered entity or another business associate.
It seems clear to me that you should be signing a business associate's agreement or changing your TOU to exclude any user from setting up forms that might collect protected health information.
- jeanettebmzAnswered on August 27, 2013 at 10:24 PM
I am having challenges in understanding what would be the next step, or where to go to proceed with your requirement. Please provide direct links to the form we should fill out and I'll consult with my higher ups
- carlygoldAnswered on August 28, 2013 at 11:20 AM
This is a sample Business Associate Agreement. It is related to HIPAA. I applaud the efforts JotForm has made to be HIPAA compliant but with new changes to the law, it is very clear that a BAA should be signed and that JotForm functions as a Business Associate by the new definition when they are allowing protected health information to be collected.
Sample Business Associate Agreement Provisions
Words or phrases contained in brackets are intended as either optional language or as instructions to the users of these sample provisions.
The following terms used in this Agreement shall have the same meaning as those terms in the HIPAA Rules: Breach, Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices, Protected Health Information, Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.
(a) Business Associate. “Business Associate” shall generally have the same meaning as the term “business associate” at 45 CFR 160.103, and in reference to the party to this agreement, shall mean [Insert Name of Business Associate].
(b) Covered Entity. “Covered Entity” shall generally have the same meaning as the term “covered entity” at 45 CFR 160.103, and in reference to the party to this agreement, shall mean [Insert Name of Covered Entity].
(c) HIPAA Rules. “HIPAA Rules” shall mean the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and Part 164.
Obligations and Activities of Business Associate
Business Associate agrees to:
(a) Not use or disclose protected health information other than as permitted or required by the Agreement or as required by law;
(b) Use appropriate safeguards, and comply with Subpart C of 45 CFR Part 164 with respect to electronic protected health information, to prevent use or disclosure of protected health information other than as provided for by the Agreement;
(c) Report to covered entity any use or disclosure of protected health information not provided for by the Agreement of which it becomes aware, including breaches of unsecured protected health information as required at 45 CFR 164.410, and any security incident of which it becomes aware;
[The parties may wish to add additional specificity regarding the breach notification obligations of the business associate, such as a stricter timeframe for the business associate to report a potential breach to the covered entity and/or whether the business associate will handle breach notifications to individuals, the HHS Office for Civil Rights (OCR), and potentially the media, on behalf of the covered entity.]
(d) In accordance with 45 CFR 164.502(e)(1)(ii) and 164.308(b)(2), if applicable, ensure that any subcontractors that create, receive, maintain, or transmit protected health information on behalf of the business associate agree to the same restrictions, conditions, and requirements that apply to the business associate with respect to such information;
(e) Make available protected health information in a designated record set to the [Choose either “covered entity” or “individual or the individual’s designee”] as necessary to satisfy covered entity’s obligations under 45 CFR 164.524;
[The parties may wish to add additional specificity regarding how the business associate will respond to a request for access that the business associate receives directly from the individual (such as whether and in what time and manner a business associate is to provide the requested access or whether the business associate will forward the individual’s request to the covered entity to fulfill) and the timeframe for the business associate to provide the information to the covered entity.]
(f) Make any amendment(s) to protected health information in a designated record set as directed or agreed to by the covered entity pursuant to 45 CFR 164.526, or take other measures as necessary to satisfy covered entity’s obligations under 45 CFR 164.526;
[The parties may wish to add additional specificity regarding how the business associate will respond to a request for amendment that the business associate receives directly from the individual (such as whether and in what time and manner a business associate is to act on the request for amendment or whether the business associate will forward the individual’s request to the covered entity) and the timeframe for the business associate to incorporate any amendments to the information in the designated record set.]
(g) Maintain and make available the information required to provide an accounting of disclosures to the [Choose either “covered entity” or “individual”] as necessary to satisfy covered entity’s obligations under 45 CFR 164.528;
[The parties may wish to add additional specificity regarding how the business associate will respond to a request for an accounting of disclosures that the business associate receives directly from the individual (such as whether and in what time and manner the business associate is to provide the accounting of disclosures to the individual or whether the business associate will forward the request to the covered entity) and the timeframe for the business associate to provide information to the covered entity.]
(h) To the extent the business associate is to carry out one or more of covered entity's obligation(s) under Subpart E of 45 CFR Part 164, comply with the requirements of Subpart E that apply to the covered entity in the performance of such obligation(s); and
(i) Make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.
Permitted Uses and Disclosures by Business Associate
(a) Business associate may only use or disclose protected health information
[Option 1 – Provide a specific list of permissible purposes.]
[Option 2 – Reference an underlying service agreement, such as “as necessary to perform the services set forth in Service Agreement.”]
[In addition to other permissible purposes, the parties should specify whether the business associate is authorized to use protected health information to de-identify the information in accordance with 45 CFR 164.514(a)-(c). The parties also may wish to specify the manner in which the business associate will de-identify the information and the permitted uses and disclosures by the business associate of the de-identified information.]
(b) Business associate may use or disclose protected health information as required by law.
(c) Business associate agrees to make uses and disclosures and requests for protected health information
[Option 1] consistent with covered entity’s minimum necessary policies and procedures.
[Option 2] subject to the following minimum necessary requirements: [Include specific minimum necessary provisions that are consistent with the covered entity’s minimum necessary policies and procedures.]
(d) Business associate may not use or disclose protected health information in a manner that would violate Subpart E of 45 CFR Part 164 if done by covered entity [if the Agreement permits the business associate to use or disclose protected health information for its own management and administration and legal responsibilities or for data aggregation services as set forth in optional provisions (e), (f), or (g) below, then add “, except for the specific uses and disclosures set forth below.”]
(e) [Optional] Business associate may use protected health information for the proper management and administration of the business associate or to carry out the legal responsibilities of the business associate.
(f) [Optional] Business associate may disclose protected health information for the proper management and administration of business associate or to carry out the legal responsibilities of the business associate, provided the disclosures are required by law, or business associate obtains reasonable assurances from the person to whom the information is disclosed that the information will remain confidential and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies business associate of any instances of which it is aware in which the confidentiality of the information has been breached.
(g) [Optional] Business associate may provide data aggregation services relating to the health care operations of the covered entity.
Provisions for Covered Entity to Inform Business Associate of Privacy Practices and Restrictions
(a) [Optional] Covered entity shall notify business associate of any limitation(s) in the notice of privacy practices of covered entity under 45 CFR 164.520, to the extent that such limitation may affect business associate’s use or disclosure of protected health information.
(b) [Optional] Covered entity shall notify business associate of any changes in, or revocation of, the permission by an individual to use or disclose his or her protected health information, to the extent that such changes may affect business associate’s use or disclosure of protected health information.
(c) [Optional] Covered entity shall notify business associate of any restriction on the use or disclosure of protected health information that covered entity has agreed to or is required to abide by under 45 CFR 164.522, to the extent that such restriction may affect business associate’s use or disclosure of protected health information.
Permissible Requests by Covered Entity
[Optional] Covered entity shall not request business associate to use or disclose protected health information in any manner that would not be permissible under Subpart E of 45 CFR Part 164 if done by covered entity. [Include an exception if the business associate will use or disclose protected health information for, and the agreement includes provisions for, data aggregation or management and administration and legal responsibilities of the business associate.]
Term and Termination
(a) Term. The Term of this Agreement shall be effective as of [Insert effective date], and shall terminate on [Insert termination date or event] or on the date covered entity terminates for cause as authorized in paragraph (b) of this Section, whichever is sooner.
(b) Termination for Cause. Business associate authorizes termination of this Agreement by covered entity, if covered entity determines business associate has violated a material term of the Agreement [and business associate has not cured the breach or ended the violation within the time specified by covered entity]. [Bracketed language may be added if the covered entity wishes to provide the business associate with an opportunity to cure a violation or breach of the contract before termination for cause.]
(c) Obligations of Business Associate Upon Termination.
[Option 1 – if the business associate is to return or destroy all protected health information upon termination of the agreement]
Upon termination of this Agreement for any reason, business associate shall return to covered entity [or, if agreed to by covered entity, destroy] all protected health information received from covered entity, or created, maintained, or received by business associate on behalf of covered entity, that the business associate still maintains in any form. Business associate shall retain no copies of the protected health information.
[Option 2—if the agreement authorizes the business associate to use or disclose protected health information for its own management and administration or to carry out its legal responsibilities and the business associate needs to retain protected health information for such purposes after termination of the agreement]
Upon termination of this Agreement for any reason, business associate, with respect to protected health information received from covered entity, or created, maintained, or received by business associate on behalf of covered entity, shall:Retain only that protected health information which is necessary for business associate to continue its proper management and administration or to carry out its legal responsibilities; Return to covered entity [or, if agreed to by covered entity, destroy] the remaining protected health information that the business associate still maintains in any form; Continue to use appropriate safeguards and comply with Subpart C of 45 CFR Part 164 with respect to electronic protected health information to prevent use or disclosure of the protected health information, other than as provided for in this Section, for as long as business associate retains the protected health information; Not use or disclose the protected health information retained by business associate other than for the purposes for which such protected health information was retained and subject to the same conditions set out at [Insert section number related to paragraphs (e) and (f) above under “Permitted Uses and Disclosures By Business Associate”] which applied prior to termination; and Return to covered entity [or, if agreed to by covered entity, destroy] the protected health information retained by business associate when it is no longer needed by business associate for its proper management and administration or to carry out its legal responsibilities.
[The agreement also could provide that the business associate will transmit the protected health information to another business associate of the covered entity at termination, and/or could add terms regarding a business associate’s obligations to obtain or ensure the destruction of protected health information created, received, or maintained by subcontractors.]
(d) Survival. The obligations of business associate under this Section shall survive the termination of this Agreement.
(a) [Optional] Regulatory References. A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.
(b) [Optional] Amendment. The Parties agree to take such action as is necessary to amend this Agreement from time to time as is necessary for compliance with the requirements of the HIPAA Rules and any other applicable law.
(c) [Optional] Interpretation. Any ambiguity in this Agreement shall be interpreted to permit compliance with the HIPAA Rules.
- JotForm SupportMike_TAnswered on August 28, 2013 at 02:56 PM
We follow best security practices, but we are not a HIPAA business associate. As far as I understand, it is not likely that we can sign a Business Associate's Agreement as we are not authorized by HIPPA.
I have escalated this thread to our Administrators.
We will let you know if we have any updates. Thank you for using our service.
- carlygoldAnswered on August 28, 2013 at 03:01 PM
By definition in HIPAA/HITECH law that is new- it sounds like if you allow your users to collect PHI using your service, then you ARE a business associate. This is relatively new and open to a some interpretation perhaps- but it is of concern.
Many small, and not so small, practices use services such as yours that are secure but now they are defined as Business Associates.
I hope you will have your legal experts review this. I look forward to their response.
- JotForm SupportMike_TAnswered on August 28, 2013 at 05:24 PM
I am going to add that information about the changes for Business Associates to the ticket.
- CarlaAnswered on September 20, 2013 at 05:11 PM
IAny response to this yet from your Administrators?
Here is a quote re: the new rule and definition of business associate:
The final rule amends the definition of a “business associate” to mean a person or entity that creates, receives, maintains or transmits protected health information to perform certain functions or activities on behalf of a covered entity.
If I use your service and collect PHI- then you are a business associate.
Here is a statement from the Morgan, Lewis & Bockius law firm:
A company that satisfies the business associate definition will be regulated on Sept. 23 even if it has not signed any BAAs.
It seems to me that Jotform is a business associate- unless they can make the case they are only a conduit. Please affirm your position on this soon.
- JotForm SupportMike_TAnswered on September 20, 2013 at 05:55 PM
We apologize, but we do not have any updates at this time. However, the ticket is open in our system. As soon as we have any more information, we will post it here.
- HoustonthyroidAnswered on October 24, 2013 at 03:40 AM
Any updates on this? If you don't sign a business associate agreeement, then no healthcare entity should use your services
- khrisellAnswered on October 24, 2013 at 04:18 AM
Kindly open a new thread for your inquiry,You can create your new thread using this link http://www.jotform.com/contact. so we can better track the issues, requests and solutions users are having. Also, to assist you better and avoid confusion.
Thank you and looking forward to assist you.