I love learning about new assets communities can access through their library. Tools, ties, seeds, toys…this list is endless.
This is the first question “Ask the Lawyer” has received about health monitoring devices and medical supplies, and the member has rightly pointed out that there is a lot to consider in such a venture. How can such lending be done with an emphasis on safety, and limiting legal risk for a library?
But before we delve into disclaimers and liability (yes, a disclaimer is going to be needed), let’s confirm some terminology.
In New York, Telehealth is defined[1] as “the use of electronic information and communication technologies to deliver health care to patients at a distance.”
Meanwhile, Telemedicine is defined[2] as “two-way electronic audio-visual communications to deliver clinical health care services to a patient at an originating site by a telehealth provider located at a distant site.”
In other words, Telemedicine is also Telehealth--but Telehealth is more than Telemedicine. “Telehealth” is like the largest figure in a Russian nesting doll set, with Telemedicine (audio-visual communication of services) contained within—but separate.
The equipment being considered by the member are equipment for Telehealth, not the transmission of Telemedicine. This has a lot of ramifications for liability and legal compliance, so it is important to take care in making the distinction from the start.
When considering the cataloging and lending of equipment for Telehealth, there are two other critical terms:
Store-and-Forward Technology, which is defined[3] as “asynchronous, electronic transmission of a member's health information in the form of patient-specific pre-recorded videos and/or digital images from a provider at an originating site to a telehealth provider at a distant site.”
…and…
Remote Patient Monitoring, which is defined[4] as “the use of digital technologies to collect medical data and other personal health information from members in one location and electronically transmit that information securely to health care providers in a different location for assessment and recommendations.”
“RMP,” as it is also called, includes the collection of information such as vital signs, blood pressure, heart rate, weight, blood sugar, blood oxygen levels and electrocardiogram readings; the type of monitoring the devices in the member’s question are about.
Okay, with that established…
YES, in lending such equipment, there are some concerns about risk and liability. YES, a disclaimer is a good idea. And there are a few other considerations, too…related to procurement, cataloging, and lending (but in the end, all relevant to the issues of risk and liability).
How does a library address those considerations? There are many details, but here is a process to systematically take them on:
Step One: Make it incremental
What do I mean by “incremental?”
I mean, instead of cataloging a kit of equipment as a single item, each item in the kit (and perhaps the bag itself) should be cataloged as a separate item. That way, when the patron borrows the bag and the equipment, they will borrow them as separate components…the way another patron might check out the entire “Harry Potter” series and a DVD of “Goblet of Fire.” [5]
Why? Because each piece of health-related or medical equipment comes with its own set of legal terms (warrantees, disclaimers) and operating instructions. By lending that equipment on a piece-by-piece basis, rather than in kits with multiple components checked out as a single unit, a library will be able to use that level of detail to take the liability-limiting and risk management steps I describe below.
Step Two: Know the devices
The member’s question lists the following telehealth equipment: “…a blood pressure cuff, pulse oximeter, a forehead thermometer, and a bag to hold the equipment.”
This list makes sense, since “remote patient monitoring,” as described by the New York Department of Health,[6] uses instruments to measure vital signs, blood pressure, heart rate, weight, blood sugar, blood oxygen levels and electrocardiogram readings, so that information can be used to provide telemedicine.
How can a library “know” the equipment? Before a Telehealth device is added to a catalog, a library should a) confirm it is commonly used for telehealth, b) confirm it meets your library’s procurement requirements; c) confirm that the precise device is registered with the FDA, and d) use the FDA site to confirm it has not been recalled.
The best place to do this is: https://accessgudid.nlm.nih.gov/.
Step Three: Plan to include the instructions
If the device comes with instructions, ensure the physical copy of the instructions is lent along with the device,[7] and generate a link or QR code so the instructions (in an ADA accessible format) can easily be found online.
This is so the borrower is empowered to use the device per the manufacturer’s instructions. This is a key component of limiting the risks associated with lending devices of any kind—including health-related equipment.
Step Four: Set the Requirements for procurement
In addition to the Procurement Policy your library must follow, the following requirements should be in the RFP or RFQ for each device:
- Will not transmit data OR any data transmission capability the device has meets current transmission requirements for telehealth;
- Any digital memory the device has must be capable of deletion with no ability to recall the prior data;
- Any device supplied must be registered with and thus listed on the FDA’s medical device database (and searchable by name or number);
- There should be no parts intended for insertion into the body;
- There should be no need for replacement parts;
- There should be clear instructions for cleaning the device between uses, and those instructions should be a process staff can perform safely;
- The purchasing decision should consider if/how the product is powered (battery, charging station) and plan to support that during lending;
- There should be no safety recall.
Step Five: Be ready to continuously monitor for recall
This is critical—and why any device included in the collection should be registered with the FDA. Prior to lending (every time), it should be confirmed at https://accessgudid.nlm.nih.gov/ that the device has not been recalled by the FDA.
Step Six: Confirm Functionality after Every Return
This, too, is critical. Prior to lending (every time), it should be confirmed that the device is functioning properly, as described by the product’s instructions.
Step Seven: Consider bringing in a ringer
Prior to making the equipment ready for lending, consider launching the collection in connection with a public health partner in your community.
Why?
The ability to borrow a thermometer, or a blood pressure cuff, or pulse oximeter, could be a game-changer if a person’s own equipment is stolen, damaged, or lost.[8] For people in rural areas who must order equipment and wait for delivery, it could facilitate the immediate start of Telehealth care, or ensure continuity of care while a replacement is on its way. This project you are considering could save lives.
That said, people should only use telehealth equipment in connection with ongoing care from their health care provider.
I am well aware of the cruel irony in this caveat. Not all people have access to reliable health insurance or ongoing healthcare,[9] and thus might need to DIY their care with telehealth devices. But the concept of telehealth ONLY works if it is in conjunction with a health care provider.
No one should be borrowing a library’s telehealth resources to use them in a health care vacuum.
This is where a public health partner could come in. If the equipment is linked to information about a clinic or other local health care provider in your region who can help a patron connect to care, you can mitigate this risk, and urge the proper use of Telehealth equipment, while respecting the privacy and autonomy of patrons.
This awareness should be part of your disclaimer.
Step Eight: Yes, you should include a disclaimer
…and it is on a device-by-device basis.
Of course, any disclaimer should only be adopted after review by your library’s attorney AND insurance carrier.[10] But here is a place for them to start:
“Prior to being borrowed, this equipment has been confirmed as not under recall by the United State Food and Drug Administration (“FDA”), and to be functioning per the manufacturer’s specifications.
However, the [NAME] library cannot confirm that the equipment will remain functional or unrecalled while it is on loan. To determine proper functioning, please refer to the instructions, and check the recall status of the device at at https://accessgudid.nlm.nih.gov/.
This is borrowed equipment. You must follow the cleaning directions in the instructions before using this equipment.
Please review the instructions and notify the library immediately at (#####) in the event the equipment is not functioning as the instructions describe.
Use of this equipment should only be in conjunction with service from a licensed health care provider familiar with your medical needs.
In the event you do not have access to a licensed health care provider, call [community health partner] to inquire about health care in the [NAME] region. The library has confirmed that this resource can assist you in finding care.
In the event of a medical emergency, dial 911.”
Step Nine: (If You have Room) Let them Know Their Rights
In the State of New York, patients being treated through telemedicine have certain legal rights. [11] If feasible, it would be good to foster awareness of these legal rights when lending telehealth equipment.
Here is a sample notification:
This equipment is for temporary use when being treated via Telehealth. It should only be used in connection with service from your health care provider.
If you are being treated by telehealth in New York, here are your rights:
Any practitioner starting a course of telemedicine should provide a patient with basic information about the services that they will be receiving via telehealth, and obtain their consent to participate in services utilizing this technology.
Telehealth sessions/services may not be recorded without the member's consent.
Patients have the right to refuse to participate in services delivered via telehealth and must be made aware of alternatives and potential drawbacks of participating in a telehealth visit versus a face-to-face visit.
Patients must be informed and made aware of the role of the practitioner at the distant site, as well as qualified professional staff at the originating site who are going to be responsible for follow-up or ongoing care.
Patients must be informed and made aware of the location of the distant site and all questions regarding the equipment, the technology, etc., are addressed.
Patients have the right to have appropriately trained staff immediately available to them while receiving the telehealth service to attend to emergencies or other needs.
Patients have the right to be informed of all parties who will be present at each end of the telehealth transmission.
Patients have the right to select another provider and be notified that by selecting another provider, there could be a delay in service and the potential need to travel for a face-to-face visit.
Step 10: Plan and budget to clean the Equipment Upon Return
However the instructions state the equipment should be cleaned, it must be cleaned (every time). Developing a protocol to do this safety is something your library must consider during both procurement and budgeting for the staff time needed to lend and maintain the equipment.
And that’s it!
Okay..I admit “it” is “a lot.” The big take-away here is that, in addition to considering liability concerns and a disclaimer, your library must ensure it has the staff, storage, and maintenance capacity to engage in appropriate risk management. That will take some planning, and some resources beyond simply buying the equipment.
That said, I suspect it will be worth it.[12]
I hope a worthy initiative like this can find a strong community health partner in the member’s region. With a health care supporting your staff in selecting the right equipment, choosing the best brands, and pushing out information about patient rights and public health, this program could truly save lives.
Please let me know how it goes.[13]
[1] NYS Public Health Law § 4406-g (2).
[2] NY CLS Pub Health § 2805-u 1.(d).
[3] NYS Public Health Law § 2999-cc, 6. PLEASE NOTE: if your library is considering providing equipment to assist with “store-and-forward” a rigorous ethics, security, and HIPAA compliance check should be part of procurement.
[4] NYS Public Health Law § 2999-cc, 7.
[5] In Harry Potter, they practiced telemedicine via the Floo Network. (P.S. If you think I threw in this Harry Potter reference to enliven a dull list of footnoted citations, you are right!).
[6] As found on April 14, 2020, at https://health.ny.gov/health_care/medicaid/program/update/2019/2019-02_speced.htm#definition
[7] I appreciate that this may involve the use of a laminator or other cool process libraries use to unnaturally extend the life of print media. Wait until you see Step Ten.
[8] Or if the patron is in a coverage dispute with their carrier. I have had some experience with this; not fun.
[9] https://www.health.ny.gov/press/releases/2019/2019-10-02_uninsured_rate.htm
[10] Your carrier should also be apprised of the undertaking, in general. They may even have some helpful tips for you in developing the lending program.
[11] As set forth in the NYSDOH guidance document found on April 14, 2020, at https://health.ny.gov/health_care/medicaid/program/update/2019/2019-02_speced.htm#definition, with citations to relevant laws and regulations.
[12] As I write this, the state is still on “PAUSE” due to COVID-19. The use of telehealth during the time has SOARED. And reading projections for the future, it will only increase.
[13] Adams@stephaniecoleadams.com or call at (716) 464-3386.