BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 464|
|Office of Senate Floor Analyses | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
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THIRD READING
Bill No: SB 464
Author: Hernandez (D)
Amended: 4/27/15
Vote: 21
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 8-0, 5/4/15
AYES: Hill, Bates, Block, Galgiani, Hernandez, Jackson,
Mendoza, Wieckowski
NO VOTE RECORDED: Berryhill
SUBJECT: Healing arts: self-reporting tools
SOURCE: Author
DIGEST: This bill 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.
ANALYSIS:
Existing federal law:
1)Authorizes the Federal Food and Drug Administration (FDA) 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:
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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
any of its primary intended purposes. (21 USC § 201(h))
Existing state 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.
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Background
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
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."
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.
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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.
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.
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.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:NoLocal: No
SUPPORT: (Verified5/4/15)
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Community Action Fund of Planned Parenthood of Orange and San
Bernardino Counties
Icebreaker Health
NARAL Pro-Choice
Planned Parenthood Action Fund of the Pacific Southwest
Planned Parenthood Action Fund of Santa Barbara, Ventura and San
Luis Obispo Counties
Planned Parenthood Advocacy Project Los Angeles
Planned Parenthood Mar Monte
Planned Parenthood Pasadena and San Gabriel Valley
OPPOSITION: (Verified5/4/15)
None received
ARGUMENTS IN SUPPORT: Icebreaker Health writes,
"Self-screening tools and use of self-reported biometrics are
increasingly being utilized by the healthcare system. Medical
professionals have long accepted self-reporting of important
elements of the patient's health-related history - personal
health history, smoking history, current medication lists,
alcohol use, family medical history, etc. Such self-reported
data points are an important source of information for medical
professionals, especially when interacting with new patients.
The advent of technology now also allows health professionals to
utilize self-screening tools to collect biometrics for elements
such as self-monitored blood pressure and histories, and
self-monitored glucose and histories. These provide valuable
information that can be used to provide appropriate care for
patients.
"Given this, Icebreaker Health respectfully requests your Aye
vote for SB 464."
Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104
5/6/15 16:49:47
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