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NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
“…Bamboo’s software has fundamentally altered the practice of medicine in the U.S. to the detriment of patients with a legitimate need for controlled prescription medications and the health care providers who treat such patients…”
THE SUMMARY OF THE REPORT TO THE FDA STATES:
1. NarxCare is not non-device CDS.
NarxCare does not satisfy any of the criteria set forth in section 520(o)(1)(A)-(E) of the FD&C Act for non-device CDS products.
b. NarxCare does not satisfy section 520(o)(1)(B).
Section 520(o)(1)(B) applies to a software function that is intended for maintaining or encouraging a healthy lifestyle, and that is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition. NarxCare is not intended for maintaining or encouraging a healthy lifestyle, and its intended use is related to the mitigation or prevention of disease.
As FDA explains in its guidance on 520(o)(1)(A)-(D), FDA considers a product with an intended use for maintaining or encouraging a “healthy lifestyle” to mean a product with an intended use that encourages or maintains a “general state of health or healthy activity,”
c. NarxCare does not satisfy section 520(o)(1)(C).
Section 520(o)(1)(C)(iii) applies to a software function intended to serve as electronic patient records, so long as, among other things, “such function is not intended to interpret or analyze patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.”
However, NarxCare is intended to interpret or analyze patient records for the purpose of the mitigation or prevention of SUDs, including the disease of opioid use disorder. Therefore, the software does not satisfy section 520(o)(1)(C).
d. NarxCare does not satisfy section 520(o)(1)(D).
Section 520(o)(1)(D) applies to a software function intended for “transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results . . . unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings.”
NarxCare does not satisfy 520(o)(1)(D) because to the extent it could be construed as incorporating data from a clinical laboratory or other medical devices, the software is intended to interpret or analyze PDMP and non-PDMP data to produce predictive risk scores for SUDs, including the disease of opioid use disorder.
e. NarxCare does not satisfy section 520(o)(1)(E).
Section 520(o)(1)(E) sets forth four additional criteria a software function must satisfy to be considered non-device CDS and excluded from regulation as a medical device. FDA’s guidance on Subsection (E) summarizes the four criteria and establishes defined terms as follows:
Non-Device CDS software functions do not acquire, process, or analyze images, signals from an in vitro diagnostic device (IVD), or patterns or signals from a signal acquisition system (Criterion 1). Non-Device CDS software functions display, analyze, or print medical information (Criterion 2) in order to provide recommendations about a patient’s care to an HCP user
(Criterion 3)… Non-Device CDS software functions provide sufficient information about the basis for the recommendations to the HCP user so that the user does not rely primarily on any of the recommendations to make a clinical decision about an individual
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“…Bamboo’s software has fundamentally altered the practice of medicine in the U.S. to the detriment of patients with a legitimate need for controlled prescription medications and the health care providers who treat such patients…”
VENDOR FRAUD
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i. Criterion 3
” With respect to Criterion 3—software functions “intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition”—FDA’s guidance states:
FDA interprets Criterion 3 to refer to software that provides condition-, disease-, and/or patient-specific recommendations to an HCP to enhance, inform and/or influence a health care decision but is not intended to replace or direct the HCP’s judgment . . . [I]n cases where a software function provides a specific preventive, diagnostic or treatment output or directive, the software function fails Criterion 3 because it is not intended for the purpose of supporting or providing recommendations under section 520(o)(1)(E)(ii) . . .
FDA considers [the level of software automation] when determining whether a software function is being used to enhance, inform and/or influence an HCP’s decision-making (satisfying Criterion 3) or, rather, to substitute, replace, or direct the HCP’s judgment (failing Criterion 3).
Automation bias is the propensity of humans to over-rely on a suggestion from an automated system . . . Automation bias may be more likely to occur if the software provides a user with a single, specific, selected output or solution rather than a list of options or complete information for the user to consider. In the former case, the user is more likely to accept a single output as correct without taking into account other available information to inform their decision-making.
This understanding of automation bias informs the FDA’s interpretation of “support or provide recommendations” in Criterion 3, as well as FDA’s interpretation that Non-Device CDS software functions allow an HCP to independently review the basis for the recommendations presented by the software so that they do not rely primarily on such recommendations, as described in Criterion 4 . . .
[S]oftware that provides a specific preventive, diagnostic, or treatment output or directive . . . would not satisfy Criterion 3. FDA interprets the purpose of such software functions as not supporting or providing recommendations to an HCP, but rather as directing the HCP to take a specific action and substituting for their judgment . . .
Note that FDA considers software that provides information that a specific patient “may exhibit signs” of a disease or condition or identifies a risk probability or risk score for a specific disease or condition as providing a specific preventive, diagnostic, or treatment output. Therefore, such software would not satisfy Criterion 3. . .
[A] [s]oftware function that identifies patients with possible
diagnosis of opioid addiction based on analysis of patient-specific
medical information, family history, prescription patterns, and
geographical data . . . is a device function. It does not meet Criterion
Three because it provides a specific diagnostic or treatment output or
Similar to the examples emphasized above, NarxCare’s algorithms analyze patient-specific medical history and prescription patterns drawn from the PDMP (i.e., number of providers, number of pharmacies, MMEs dispensed, overlapping prescription days, and potentiating medications) and non-PDMP information, which may include criminal history, payment method, and geographical data, to “calculate a patient’s risk of a host of outcomes, including overdose and addiction.”104
In other words, the software produces risk score outputs intended to prevent accidental drug poisonings and the disease of opioid use disorder and other SUDs.
NarxCare’s risk scores are also susceptible to automation bias given that prescribers increasingly fear potential legal repercussions related to prescribing opioids and other controlled medications. For example, a prescriber who sees a report with a moderate to high NarxScore or overdose risk score very likely could, without further investigation of the patient’s health record, interpret the score as a “do not prescribe” directive and decide to not prescribe an opioid medication to a patient with pain.
In short, NarxCare does not just influence prescribers and dispensers when determining whether a controlled medication is appropriate for a patient and the associated risks to that individual—it often replaces their judgment altogether. Therefore, NarxCare cannot satisfy section 520(o)(1)(E)(ii) of the FD&C Act.”
“…Bamboo’s software has fundamentally altered the practice of medicine in the U.S. to the detriment of patients with a legitimate need for controlled prescription medications and the health care providers who treat such patients…”
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