EIGHTEENTH CONGRESS OF THE 
)
REPUBLIC OF THE PHILIPPINES 
)
Second Regular Session 
)
pill
20 OCT 14 PI 54
SENATE
Introduced by Senator Francis "ToI" N.wTolentino
AN ACT
EXPANDING THE DEFINITION OF "MEDICAL DEVICE" TO INCLUDE 
HEALTH APPLICATIONS, FURTHER AMENDING REPUBLIC ACT NO. 3720, 
OTHERWISE KNOWN AS THE "FOOD, DRUG, AND COSMETIC ACT," AS 
AMENDED BY REPUBLIC ACT NO. 9711, OTHERWISE KNOWN AS THE 
"FOOD AND DRUG ADMINISTRATION (FDA) ACT OF 2009" AND FOR
OTHER PURPOSES
Explanatory Note
Software and mobile applications have become a useful tool in improving one's 
health. They can help boost over-all health and well-being and provide valuable health- 
related information. These applications or "apps," which are easily downloadable and readily 
available in app stores, address a wide variety of health-related aspects, such as nutrition, 
sleep, physical exercise, stress management, and medication reminders.
Thus, the prevalence and impacts of the mobile health industry, also known as 
"mHealth/'have become undeniable. In 2017, in the United States alone, over 318,000 
health apps were already readily available in top app stores, with more than 200 apps being 
added each day.1 The Global Mobile Health (mHealth) Market Insights and In-Depth Analysis 
2020-2027 forecasts that the value of the mobile health industry will exceed $311.98 Billion 
by 2027.2
In the Philippines, the health industry has also gone digital with the launching and 
utilization of health-related mobile applications. They are convenient, affordable, and easily
1 Mobile Health Apps: Taking a Closer Look at Compliance dated August 8, 2019; accessed at 
https://liquid-state.com/mobile-health-apps-compIiance/
2 Industry Overview of Mobile Health (mHealth) Market Report dated September 26, 2020; accessed 
at https://www.openpr.com/news/2143577/globaI-mobile-heaIth-mheaIth-market-insights-and-in-depth


accessible to consumers. Digital healthcare ranges from online medical consultation or 
telemedicine apps to health assessment and monitoring apps for both physical and mental 
health. Currently, the primary use for health apps is for contact-tracing, which is a key 
public health intervention against the novel Coronavirus 2019 disease (COVID-19) as these 
apps break the chain of transmission by identifying and Isolating persons who came into 
contact with an infected individual.
The use of contact-tracing apps has been effectively utilized by other countries in 
battling the COVID-19 pandemic, such as Singapore with its TraceTogether app, Germany 
with its Corona-Warn-App, Australia with its COVIDSafe app, and France with its StopCovid 
app.3
In the Philippines, the application StaySafe.ph was recently launched as the official 
contact tracing program of the government. It has been described as a game-changer in the 
fight against COVID-19. As of 10 September 2020, there were two million Filipinos and some 
3,000 businesses registered under the StaySafe.ph app.4
Indeed, digital health technologies are valuable tools in the management of the 
COVID-19 response by helping public health officials reach and deliver information to a vast 
number of people more quickly, efficiently, and effectively. However, the definition of 
medical devices under Republic Act (R.A.) No. 3720, as amended by R.A. No. 9711, remains 
outdated and archaic in contrast to the rapid advances of technology in the medical field. 
The law does not sufficiently contemplate applications and digital platforms which have 
become an integral part of medical products.
Hence, there is an urgent need to amend the law. If software and mobile medical 
applications remain unregulated, the diagnosis, treatment, or prescription of medicines 
through these applications could potentially result in life-threatening consequences. 
Moreover, without proper licensing and registration, claims against medical malpractice and 
civil liabilities could be painstaking and difficult.
This bill seeks to further amend R.A. No. 3720 in order to redefine the term "medical 
device" to emphasize the inclusion of software and health applications under such definition 
and clarify the jurisdiction of the Food and Drug Administration (FDA) over such medical 
devices.
In light of the foregoing, the passage of this bill is earnestly sought.
"TOL" N. TOLENTINO
Senator
3 Contact tracing apps: A new world for data privacy dated October 2020. Norton Rose Fulbright; 
accessed at https://www.nortonrosefuIbright.com/en-us/knowledge/publications/d7a9a296/contact- 
tracing-apps-a-new-world-for-data-privacy
4 About 2 million Filipinos now registered in contact tracing app dated September 10, 2020, CNN 
Phiiippines; accessed at https://www.cnnphiiippines.eom/news/2020/9/10/staysafe-contact-tracing- 
app-users-about-two-miiiion-fiiipinos.htmi


EIGHTEENTH CONGRESS OF THE 
)
REPUBLIC OF THE PHILIPPINES 
)
Second Regular Session 
)
Senate
' 
ot tljr ^rtn'tarn
20 OCT U Pr-54
SENATE
Introduced by Senator Francis "Tol" N. Tolentino
AN ACT
EXPANDING THE DEFINITION OF "MEDICAL DEVICE" TO INCLUDE 
HEALTH APPLICATIONS, FURTHER AMENDING REPUBLIC ACT NO. 3720, 
OTHERWISE KNOWN AS THE "FOOD, DRUG, AND COSMETIC ACT," AS 
AMENDED BY REPUBLIC ACT NO. 9711, OTHERWISE KNOWN AS THE 
"FOOD AND DRUG ADMINISTRATION (FDA) ACT OF 2009" AND FOR
OTHER PURPOSES
Be it enacted by the Senate and House of Representatives of the Phiiippines in 
Congress assembied:
1 
Section 1. Section 10 (g) (1) of RA No. 3720, as amended, is hereby amended
2 
to read as foliows:
3
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"SEC. 10. For the purposes of this Act, the term:
5 
"XXX
6 
"(g) 'Device' means medicai devices, radiation devices and heaith-reiated
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devices.
8 
"(1) 'Medicai device' means any instrument, apparatus, impiement, machine,
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appiiance, impiant, in-vitro reagent or caiibrator, software OR HEALTH
10 
APPLICATION, material, or other similar or related article intended by the
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manufacturer to be used alone, or in combination, for human beings for one
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or more of the specific purpose(s) of: diagnosis, prevention, monitoring,
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treatment or alleviation of disease; diagnosis, monitoring, treatment,
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alleviation of, or compensation for an injury; investigation, repiacement, 
modification, or support of the anatomy or of a physiological process; 
supporting or sustaining iife; preventing infection; control of conception; 
disinfection of medical devices; and providing information for medical or 
diagnostic purposes by means of in-vitro examination of specimens derived 
from the human body. This device does not achieve its primary intended 
action in or on the human body by pharmacoiogical, immunoiogical, or 
metabolic means but which may be assisted in its intended function by such 
means.
"X XX"
Section 2. Section 10 of RA No. 3720, as amended, is hereby further 
amended to insert a new subsection (nn) to read as foilows:
"SEC. 10. For the purposes of this Act, the term:
"XXX
"(NN) 'SOFTWARE OR HEALTH APPLICATION, AS USED IN THIS ACT, 
MEANS A MEDICAL DEVICE THAT CAN BE INSTALLED AND/OR 
OPERATED ON MOBILE PHONES, TABLETS, COMPUTERS, OR ANY 
OTHER COMMERCIAL OFF-THE-SHELF COMPUTING PLATFORM, 
WITH OR WITHOUT WIRELESS CONNECTIVITY. ITS FUNCTIONS 
SHALL INCLUDE, BUT ARE NOT LIMITED, TO ANY OF THE 
FOLLOWING:
a. CALCULATE MEDICINE DOSES FOR THE USER;
b. DIAGNOSE A MEDICAL CONDITION OR DISEASE;
c. GIVE THE USER AN INDIVIDUAL PERCENTAGE RISK SCORE OF 
HAVING A MEDICAL CONDITION OR DISEASE;
d. PRESCRIBE CURE, MITIGATION, TREATMENT, OR PREVEN­
TION OF DISEASE; OR
e. DETERMINE CONTACT BETWEEN AN INFECTED PERSON AND A 
USER."


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Section 3. Separability Clause. If any provision of this Act is deciared 
unconstitutional or Invalid, other sections or parts thereof not affected thereby shall 
remain in full force and effect.
Section 4. Repealing Clause. All laws, decrees, executive orders, rules, and 
regulations, or parts thereof, inconsistent with the provisions of this Act are hereby 
repealed or modified accordingly.
Section 5. Effectivity Clause. This Act shall take effect fifteen (15) days after 
its complete publication in the Official Gazette or In at least one (1) newspaper of 
general circulation.
Approved,