Steve Fox interviewed by InformationWeek about EHR contracts

Our own Steve Fox was interviewed by InformationWeek regarding the essential protections healthcare providers should include in their EHR contracts with health IT  vendors.  In particular, Steve warned providers against simply accepting vendor agreements without carefully reviewing and negotiating the key provision therein. Via InformationWeek:

"Many health IT vendors offer online contacts that prompt the physician to click the 'agree' button. Unfortunately some of these agreements have no warranties and in fact disclaim many standard warranties, so the vendors are selling their products 'as is,' which means if something goes wrong they are not responsible," Fox told InformationWeek after his presentation. "Some contracts even go further and say if a third party, for example the patient, would sue as a result of a problem with the EHR, the physician has to indemnify and defend the vendor even if it was the vendor that caused the problem."

You can read more after the jump, or by clicking here.

 

Steve also opined on the reluctance of vendors to promise meeting future regulatory requirements, including the upcoming standards for Stages 2 and 3 of meaningful use:

"We do know there will be new meaningful use requirements for Stage 2 and 3, and it's a moving target. Many vendors are unwilling to agree to future, unknown regulations, saying 'We don't know what we don't know,' but vendors need to remember that providers are paying them a lot of money for support and maintenance to meet those requirements. This is a big area of tension between providers and vendors right now," Fox said.

Finally, Steve offered a few suggestions on some of the critical provisions relating to data access and ownership, as well as safeguarding the privacy and security of protected data:

For those providers adopting software-as-a-service models to outsource their EHRs, Fox recommends that providers restrict vendors from holding data "hostage" and ensure unfettered access to customer data, including protected health information (PHI), on vendors' systems.

He also said providers should insist that vendors routinely back-up data and mandate the return of customer data upon termination of the contract as well as ensure security of data and access to such data if the vendor goes out of business.

With regard to security, Fox said providers need to stress confidentiality of PHI and make clear who owns the data and establish guidelines for the use of data by a vendor. Healthcare providers should also negotiate agreements that include intellectual property issues, obligations of nondisclosure, remedies for breach of patient information, and indemnification obligations.

"Health IT Contracts Offer Little Protection For Buyers," InformationWeek (August 24, 2010).

 

Major breach at a New York hospital affects over 130,000 patients

Lincoln Medical and Mental Health Center (LMMHC) in New York suffered a major breach affecting 130,495 of its patients, according to a notice provided to HHS.  The breach occurred when the hospital's contractor, Siemens Medical Solutions USA, shipped seven password-protected, but not encrypted, CDs containing patient information via FedEx; and these CDs were subsequently lost in transit.  Via Bloomberg Business Week:

The CDs were sent by the hospital's billing processor, Siemens Medical Solutions USA, around March 16, but never arrived at their intended destination. They included sensitive health and personal information including Social Security numbers, addresses, dates of birth, health plan numbers, driver's license numbers and even descriptions of medical procedures, the hospital said on a note posted to its Web site.

<...> Siemens is no longer FedExing CDs to Lincoln, the hospital said. It is not aware of any of the data being improperly accessed.

LMMHC's breach should serve as a reminder for all healthcare providers currently negotiating health IT contracts to include proper protections in the event its vendor causes a breach or loss of protected data.  This is particularly crucial in the post-HITECH Act era.  

We always include specific compliance with privacy laws warranties, indemnification clauses and limitation of liability carve-outs for vendor's own negligent acts or omissions which result in a data breach or loss.  LMMHC's example clearly illustrates that providers must insist on such protections -- often, over strenuous objections from vendors -- because, otherwise, providers may be exposed to a wide range of expenses and damages from third-party claims, fines, investigations and breach notification associated with a data breach or loss resulting from vendor's actions.

For more information, please listen to or view the slides from our Webinar on negotiating "must-have" provisions in HIT contracts.

"New York hospital loses data on 130,000 via FedEx," Bloomberg Business Week (June 29, 2010).

A note of caution about vendor guarantees on "meaningful use"

According to Modern Healthcare, several HIT vendors, including GE Healthcare, NextGen Healthcare Information Systems, and Athenahealth, will guarantee that their EHR products will meet or "evolve to meet" the federal requirements for "meaningful use," even though such requirements have not been promulgated yet by CMS.  In fact,

Athenahealth recently upped the ante by guaranteeing that, not only will the company's AthenaClinicals Internet-based electronic health-record service meet federal standards, but the doctors who use it will receive a bonus payment for the 2011 program year under the terms of the [HITECH Act].

The HITECH Act provides for a first-year incentive payment of $18,000 for those eligible professionals who achieve meaningful use of certified EHR technology in 2011 or 2012, instead of a first-year payment of $15,000 thereafter.

Some vendors hope that such guarantees will spur activity in the market, persuading some reluctant healthcare providers not to wait until CMS issues its final "meaningful use" regulations next year.  There is also some doubt whether such guarantees apply to each vendor's existing customers or solely to new customers.

However, whenever a healthcare organization enters into an EMR purchase or license agreement, it must obtain strong warranties from the vendor that its product(s) and system will meet the applicable federal requirement standards at time of issuance of such standards, as well as for duration of the applicable license.  "Meaningful use" requirements will likely change over the life of a license, and a vendor's obligation to meet such evolving standards is absolutely essential.  Healthcare providers must also include proper remedies and appropriate carve-outs from vendor's limitation of liability for a vendor's breach of such warranties.

Of course, such warranties are just the tip of the iceberg.  If meeting "meaningful use" criteria is essential to your healthcare organization, your EMR license agreements should include robust testing and acceptance provisions; vendor warranties regarding meeting major milestones on time; warranties regarding compliance with patient information privacy and security laws; clauses securing your ownership and access to patient data, along with many other significant provisions.

"HITS Beyond: IT vendors say products will meet unknown guidelines," Modern Healthcare (September 28, 2009).