BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: SB 464 Hearing Date: May 4, 2015
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|Author: |Hernandez |
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|Version: |April 27, 2015 |
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|Urgency: |No |Fiscal: |No |
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|Consultant|Sarah Huchel |
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Subject: Healing arts: self-reporting tools.
SUMMARY: Authorizes the Medical Board of California to consider
the use of self-screening tools by a licensee, as that use may
be allowed by law.
Existing federal law:
1)Authorizes the Federal Food and Drug Administration to
regulate drugs and medical devices. (Title 21 United States
Code (USC) § 301 et seq.)
2)Defines a medical device as "an instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or
other similar or related article, including a component part,
or accessory which is:
a) Recognized in the official National Formulary, or the
United States Pharmacopoeia, or any supplement to them.
b) Intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals.
c) Intended to affect the structure or any function of the
body of man or other animals, and which does not achieve
its primary intended purposes through chemical action
within or on the body of man or other animals and which is
not dependent upon being metabolized for the achievement of
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any of its primary intended purposes. (21 USC § 201(h))
Existing law:
1)Establishes the Medical Board of California (Board) to
administer the Medical Practice Act (Act). (Business and
Professions Code (BPC) §§ 2001 and 2004)
2)Prohibits any person or entity from prescribing, dispensing,
or furnishing dangerous drugs or dangerous devices on the
Internet for delivery to any person in California without an
appropriate prior examination and medical indication, except
as specified.
3)Defines "dangerous drug" or "dangerous device" as any drug or
device unsafe for self-use in humans or animals, and includes
the following:
a) Any drug that bears the legend: "Caution: federal law
prohibits dispensing without prescription," "Rx only," or
words of similar import.
b) Any device that bears the statement: "Caution: federal
law restricts this device to sale by or on the order of a
____," "Rx only," or words of similar import, the blank to
be filled in with the designation of the practitioner
licensed to use or order use of the device.
This bill authorizes the Board to consider the use of
self-screening tools by a licensee, as that use may be allowed
by law.
FISCAL
EFFECT: This bill has been keyed "nonfiscal" by Legislative
Counsel.
COMMENTS:
1.Purpose. This bill is sponsored by the Author . According to
the Author's office, "This bill will expand access to health
care through the use of new and innovative technology that
will connect patients with their health care provider more
SB 464 (Hernandez) Page 3
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efficiently and cost effectively. This bill will promote the
use of self-screening tools to allow a patient to communicate
important information to their provider when appropriate.
Using these tools in mobile and web-based technologies will
increase the use of telehealth in all communities -- rural,
urban, and suburban and in underserved areas."
The Author further states that, "Existing law is not clear as
to whether self-screening tools can be used to transmit
relevant medical and family history information from a patient
to his or her provider. Enabling the use of self-screening
tools, when appropriate, will allow providers to make greater
use of existing and developing technology to provide health
care through synchronous and asynchronous telehealth. For
example, the American College of Obstetricians and
Gynecologists recently recommended that women should
self-screen for contraindications using checklists to increase
their access to extremely safe hormonal contraceptives. This,
in turn, could help reduce the very high levels of unintended
pregnancies experienced in California and the rest of the
country. Self-screening tools would all be developed by the
appropriate providers, used under their direction and with a
patient's consent."
2.Medical Self-Screening Applications. The FDA is responsible
for protecting the public health by assuring that foods (with
certain exceptions) are safe, wholesome, sanitary, and
properly labeled; ensuring that human and veterinary drugs,
and vaccines and other biological products and medical devices
intended for human use are safe and effective.
In September 2013, the FDA issued final guidance for
developers of mobile medical applications, or apps, which are
software programs that run on mobile communication devices and
perform the same functions as traditional medical devices.
The FDA stated that it intends to exercise enforcement
discretion (meaning it will not enforce requirements under the
Federal Drug & Cosmetic Act) for the majority of mobile apps
as they pose minimal risk to consumers, but rather focus its
regulatory oversight on a subset of mobile medical apps that
present a greater risk to patients if they do not work as
intended.
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Mobile apps have the potential to transform health care by
allowing doctors to diagnose patients with potentially
life-threatening conditions outside of traditional health care
settings, help consumers manage their own health and wellness,
and also gain access to useful information whenever and
wherever they need it.
Mobile medical apps currently on the market can, for example,
diagnose abnormal heart rhythms, transform smart phones into a
mobile ultrasound device, or function as the "central command"
for a glucose meter used by a person with insulin-dependent
diabetes.
Mobile medical apps that undergo FDA review will be assessed
using the same regulatory standards and risk-based approach
that the agency applies to other medical devices.
The agency has cleared about 100 mobile medical applications
over the past decade; about 40 of those were cleared in the
past two years.
3.Medical Board of California. The MBC administers the Act,
which does not speak specifically to the particular use of
medical devices, but ensures that overall safety of a
physician's practice. This bill authorizes the MBC to
consider the use of self-screening tools by a licensee.
SUPPORT AND OPPOSITION:
Support: None on file as of April 29, 2015.
Opposition: None on file as of April 29, 2015.
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