Respond to this discussion post in 5-7 sentences in a positive way This enforcement policy intends to allow use of non-i
Posted: Wed Mar 09, 2022 9:49 am
Respond to this discussion post in 5-7 sentences in a positive
way
This enforcement policy intends to allow use of non-invasive
remote monitoring devices to reduce patient and healthcare provider
exposure to covid-19 during a public health emergency (1). I do
think that this policy is reasonable under current pandemic
conditions. Due to the high transmission rate of covid-19, it is
necessary to protect the healthcare community, as well as high risk
patients, so that all patients (having current covid-19 infection
or not) are able to receive and access care when needed. There are
over 20 devices that this enforcement policy covers to be used
connecting to wireless networks to relay data from patient to
provider. Patients that might be using some of these devices may
tend to be at higher risk of contracting a devastating strain of
covid-19. Unwarranted risks that may be a problem for patients and
healthcare providers are if the “device is intended to determine
when patients need immediate clinical intervention… ” and “the
device is intended to be solely… relied upon by the health care
professional or patient to make a clinical diagnosis…” 1). Having
the patient being monitored remotely will not assist the patient in
getting the swift care they may need if a device determines
immediate clinical intervention and therefore the FDA has reason to
believe the risk outweighs the benefit. In medicine, diagnoses are
not always straight forward and rely on many factors. Relying on a
remote device to diagnose or treat a patient without examining them
in person could lead to missed diagnosis or errors in treatment.
Cyber security is another real threat that could disrupt this type
of service to patients. Controls should be developed to diminish
the risk for cyber-attacks.
way
This enforcement policy intends to allow use of non-invasive
remote monitoring devices to reduce patient and healthcare provider
exposure to covid-19 during a public health emergency (1). I do
think that this policy is reasonable under current pandemic
conditions. Due to the high transmission rate of covid-19, it is
necessary to protect the healthcare community, as well as high risk
patients, so that all patients (having current covid-19 infection
or not) are able to receive and access care when needed. There are
over 20 devices that this enforcement policy covers to be used
connecting to wireless networks to relay data from patient to
provider. Patients that might be using some of these devices may
tend to be at higher risk of contracting a devastating strain of
covid-19. Unwarranted risks that may be a problem for patients and
healthcare providers are if the “device is intended to determine
when patients need immediate clinical intervention… ” and “the
device is intended to be solely… relied upon by the health care
professional or patient to make a clinical diagnosis…” 1). Having
the patient being monitored remotely will not assist the patient in
getting the swift care they may need if a device determines
immediate clinical intervention and therefore the FDA has reason to
believe the risk outweighs the benefit. In medicine, diagnoses are
not always straight forward and rely on many factors. Relying on a
remote device to diagnose or treat a patient without examining them
in person could lead to missed diagnosis or errors in treatment.
Cyber security is another real threat that could disrupt this type
of service to patients. Controls should be developed to diminish
the risk for cyber-attacks.