Wednesday, October 18, 2017
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David Willcutts
Ready Consultant, LLC

Author's Focus:
Healthcare regulatory changes in HIPAA, EHR, ARRA, ICD10, etc., as well as how to approach consulting projects from planning, engaging and managing.

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All Articles Listing
Expect States to Take Control of Health Reform
By:SWilliams - - 07/09/2010

46 states face budget shortfalls. Can they afford health reform? Read More..

Health Reform, Is Your Company's Plan Grandfathered? Be careful.
By:ReadyConsultant - - 07/07/2010

Employers who offer health coverage have many new requirements to understand related to the recently passed Affordable Care Act. Most of the major changes do not become effective until January 1, 2014 particularly given the "grandfathered" status. However, maintaining this status may be more diffic... Read More..

What's Next for ONC's Agenda with EHR's, Certification and more?
By:DWillcutts - - 01/21/2010

Information Week's recent interview with ONC's Dr. David Blumenthal provided some interesting insights into what is next and who is out there to help providers realize these goals. Where are the meaningful use guidelines? What about the certification process and who will be certifying? And is there... Read More..

NHIN Re-thought? ONC's Dr. David Blumenthal is re-envisioning
By:DWillcutts - - 01/21/2010

The six year effort by the government to create a National Health Information Network through efforts such as RHIOs is getting a fresh look. Is there practicality coming out of Washington? Or is this another twist in the road to a far off dream? At first glance, having a focus on smaller providers'... Read More..

Page:   of 16 

Sentor Grassley Keeps focus on Health IT Systems Liability and Confidentiality

DWillcutts - - 01/21/2010

Senator Grassley (R-IA) has followed up a Fall letter sent to ten Health Systems vendors with a group of letters now directed at their clients.  The Senator continues to be concerned with system vendor's efforts to both limit liability to themselves as well as create "gag orders" on the sharing of information regarding the performance of installations.  His focus is particularly on the purchasing process, implementation and how problems/issues are tracked, reported and shared.  He is highlighting the sometimes challenging process of evaluation of systems and the dangerous consequences of errors that may effect patient care.

As rationale for these inquires, Senator Grassley quotes his position as ranking member of the Senate Finance Committee with jurisdiction over Medicare and Medicaid.  In particular he is concerned with the effective use of the $19 Billion in ARRA funds directed at electronic health records.  In his letter he says:

"Over the past several months, however, I have been made increasingly aware of difficulties and challenges associated with HIT implementation. The reported problems appear to be associated with administrative complications in implementation, formatting and usability issues, and actual computer errors stemming from the programs themselves, as well as, interoperability between programs."

This would certainly not be new to anyone who has been associated with any major system implementation, particularly EHRs.  He drives this point further and more critically when he draws attentions to the possible clinical complications that could occur from system errors and where the liability lies for such errors.  He goes on to provide an example:

"For example, I have heard from health care providers regarding faulty software that produced incorrect medication dosages because it miscalculated body weights by interchanging kilograms and pounds."

Of particular interest is his concern with the transparency into problems such as these.  He has been told of "gag order" contained in vendor contracts, general difficulties of staff concerns being recognized by their facilities and the lack of any consolidated source of information on such problems.  The adverse events reporting on medical devices required by the FDA is a parrel he draws. 

Product reviews and commentaries from those involved in deploying these systems would clearly be valuable to the community and any effort to restrict such open discussion seems inappropriate.  Those covered by such restrictions should at least be able to highlight to others that they are under such a restriction which should be a red flag to anyone looking at that system.

The Senators lengthy letter has been posted in this Wall Street Journal post.  I have included the specific questions he asks below.  Please let us know your experience with these issues and if you think the Senator is focused on the right issues or creating yet another reform distraction.

Questions from Senator Grassley's letter:

"1. Please describe in detail your facility’s process for identifying HIT products for purchase and choosing an HIT vendor(s).

a. What is the personnel structure of those involved in the purchase?

b. To what extent do physicians and other health care providers within your facility provide input regarding the specific HIT items to be implemented within your facility?

c. Who or what department within your facility is responsible for making HIT purchase decisions?

2. Three of the companies that I wrote to in October 2009 informed me that they do not manufacture HIT software or hardware, but instead assist their health care clients, such as hospitals, with the implementation and management of HIT systems. To what extent do you contract with such entities to assist with the purchase, implementation and/or management of HIT products in your facility?

3. Please describe the training process implemented in your facility to familiarize employees with new technology systems.

a. How does your facility budget for HIT training?

b. What are the vendors’ roles in helping your facility train in the use of their products?

4. Does your facility have any policies or processes governing the reporting of problems or concerns by your health care employees related to the HIT products or systems implemented in your facility? If so, please provide a description of the policies or processes. If not, please explain why not.

5. When patient care and/or safety problems related to HIT systems arise, how are these problems reported within the facility and what is the process or mechanism for addressing them?

a. Are these problems also reported to the HIT vendor, and if so, what is the process for reporting them?

b. If patient care and/or safety problems related to HIT systems are not routinely reported to the HIT vendors, please explain how your facility decides which problems or issues are reported to a vendor and/or addressed by a vendor and which problems are addressed internally by the facility.

6. Please describe in detail any system your facility has in place to document, track, catalogue, and maintain complaints, concerns or issues related to HIT products that may directly or indirectly involve or impact the delivery of care or patient safety.

7. Please provide a list of HIT problems or complaints that have been identified by or reported to your facility since January 2008 that directly or indirectly impacted patient safety or the delivery of care, including any complications or adverse events that have occurred as a result of HIT product design and/or usability. Please describe whether and how each of those problems or complaints was resolved and whether these issues have resulted in a change in policy to prevent the problem in the future.

8. Does your facility have policies regarding the discussion of problems in your HIT systems with other health care facilities or with government officials or any individuals or entities outside your facility? If so, please describe those policies. To what extent are these policies driven by contractual agreements with the HIT vendors, and to what extent do they stem from internal processes? Please provide examples of contracts with HIT vendors that include non-disclosure clauses.

9. Some of the HIT vendors stated specifically in their responses to me that they do not include language that would hold them harmless for failures of their products or for the company’s own negligence or recklessness. However, they may include provisions that spell out the vendor’s and the health care client’s respective legal responsibilities and obligations in the use of the product. For example, one vendor stated that it is accountable for the performance of its product as long as the client uses the product appropriately. Another vendor stated that it is not liable when harm or loss results from the client’s use of the product in diagnosing and/or treating patients.

a. Do any of the HIT vendors include language in their contracts with your facility that could be considered “hold harmless” provisions, i.e., the transferring of liability associated with the services or products provided to your facility, or otherwise limit their liability? If so, please provide a copy of sample contracts containing such provisions.

10. What is the relationship between your facility and any HIT vendors?

a. HIT vendors that manufacture software, hardware and/or other products purchased by health care facilities have stated in their responses to me that they do not offer any financial incentives for purchasing their products, such as shares in the company or financial interests in a particular product. At least one vendor stated, however, that it does offer financial incentives in the form of discounts based on purchase size. Another vendor said that health care clients may receive royalty payments when the clients collaborate with the vendor to develop a product. What financial interest, if any, does your facility have in HIT vendors and/or their products?

b. Do the vendors offer your facility and/or any of your health care providers any financial incentives for purchasing the vendors’ products? If so, please describe the types and value of the incentives.

11. Did your staff, health care providers and/or facility receive any payments, product discounts, or other items of value from any vendor for discussing and/or promoting that vendor’s HIT products? If so, please list the different types of payments and discounts and their value. "



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