NINETEENTH CONGRESS OF THE ) 
REPUBLIC OF THE PHILIPPINES )
First Regular Session 
)
SENATE
S. No. 620
Senate
o( tlif igjrtvplavp
72 JUL14 P2:17
RECEIVED BY.__
Introduced by SENATOk 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
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 trackers and/or 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 In fact, the number of consumer digital health 
apps ballooned in 2020 with more than 90,000 new ones. The Global Mobile Health
1 Mobile Health Apps: Taking a Closer Look at Compliance dated August 8, 2019; accessed at
https://liquid-state.com/mobile-health-apps-compIiance


(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 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 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
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
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/contacttracing-apps-a-new-world-for-data-privacy
4 About 2 million Filipinos now registered in contact tracing app dated September 10, 2020, CNN
Philippines; accessed at https:/7www.cnnphiiippines.eom/news/2020/9/10/staysafe-contact- 
tracingapp-users-about-two-miiiion-fiiipinos.html


"r
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.
CI^^TOL" N. TOLENTINO


NINETEENTH CONGRESS OF THE ) 
REPUBLIC OF THE PHILIPPINES ) 
First Regular Session 
)
SENATE
s. No. R20
Senate
ffitP of tl)f !§!rrrptarp
•22 JUL14 P2:17
RECEIVED BY;
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 the House of Representatives of the Philippines in 
Congress assembled:
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Section 1. Section 10(g)(1) of RA No. 3720, as amended, is hereby amended
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to read as follows:
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"SEC. 10. For the purposes of this Act, the term:
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XXX
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(g) "Device" means medical devices, radiation devices and health-related 
devices.
(1) "Medical device" means any instrument, apparatus, implement, 
machine, appliance, implant, in-vitro reagent or calibrator, software 
OR HEALTH APPLICATION, material, or other similar or related 
article intended by the manufacturer to be used alone, or In combination, 
for human beings for one or more of the specific purpose(s) of:


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diagnosis, prevention, monitoring, treatment or alleviation of 
disease; diagnosis, monitoring, treatment, alleviation of, or 
compensation for an injury; investigation, replacement, modification, 
or support of the anatomy or of a physiological process; supporting 
or sustaining life; 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 pharmacological, 
immunological, or metaoolic means but which may be assisted in its 
intended function by such means.
X X x"
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Section 2. Section 10 of RA No. 3720, as amended, is hereby further amended
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to insert a new subsection (nn) to read as follows:
"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-1 HE-SHELF COMPUTING PLATFORM, WITH 
OR WITHOUT WIRELESS CONNECTIVITY. ITS FUNCTIONS SHALL 
INCLUDE, BUT ARE NOT LIMITED, TO ANY OF THE FOLLOWING:
(1) 
CALCULATE MEDICINE DOSES FOR THE USER;
(2) 
DIAGNOSE A MEDICAL CONDITION OR DISEASE;
(3) 
GIVE THE USER AN INDIVIDUAL PERCENTAGE RISK SCORE 
OF HAVING A MEDICAL CONDITION OR DISEASE;


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(4) PRESCRIBE CURE, MITIGATION, TREATMENT, OR
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PREVENTION OF DISEASE; OR
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(5) DETERMINE CONTACT BETWEEN AN INFECTED PERSON AND
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A USER."
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Section 3. Separability Clause. - If any provision of this Act is declared
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unconstitutional or invalid, other sections or parts not affected thereby shall remain in
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full force and effect.
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Section 4. Repealing Clause. - All laws, decrees, executive orders, rules,
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and regulations, or parts thereof, inconsistent with the provisions of this Act are
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hereby repealed, amended, or modified accordingly.
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Section 5. Effectivity Clausa. - This Act shall take effect fifteen (15) days
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after its publication in the Official Gazette or in a newspaper of general circulation.
Approved,