7. Decentralized Clinical Trials

7.1 Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)?

Yes. No regulations are preventing the conduct of a decentralized clinical trial.

7.2 Is there any specific regulation/guidance on the use of DCT elements within a clinical trial?

No. There is no specific guidance on the conduct of decentralized clinical trials.

7.3 What is the overall acceptability of DCT elements by the regulatory authorities and Ethics Committees?

There are no specific regulations that prevent the use of DCT elements in clinical trials and thus, acceptability will be determined on a case-by-case basis by the Philippine authorities.

7.4 Has a fully virtual trial (DCT) been conducted in the country yet? If so, please provide an example including the registration number and any link to it, whether COVID/non-COVID trials.

No. There is no evidence that a fully decentralized clinical trial has been conducted in the Philippines yet.

7.5 Are there any non-regulatory DCT initiatives in the country, such as where the investigator sites and local CROs founded an alliance?

No. There are no known local initiatives around DCTs.

7.6 Are there any general considerations when using DCT elements in a study?

Please refer to Sections 7.7 - 7.16 below.

7.7 Considerations/Requirements for the Use of eConsent/Remote Consent

Electronic consent is not permitted. Wet signatures are required. 

Documentation of consent 

As a rule, documentation of informed consent should include an actual signature or thumbmark of the prospective participant on the informed consent form. 

When the use of an informed consent form is not feasible or unacceptable to the prospective participant, a description of the process, attested by a witness, may be an alternative that needs prior approval of the REC. 

7.8 Considerations/Requirements for the Use of eSignatures

Wet signatures are required for informed consent. 

The Republic Act No. 8792, or the Electronic Commerce Act of 2000 and its Implementing Rules and Regulations, is the country’s centerpiece legislation on electronic commerce. The E-Commerce Act was designed to make electronic contracting legally enforceable and was intended to settle legal doubts about whether electronic forms of contracting were lawful. It recognizes electronic documents as the legal equivalent of paper documents, and electronic signatures as the legal equivalent of handwritten signatures.

Also important are the Supreme Court of the Philippines’ Rules on Electronic Evidence (REE), the Department of Trade and Industry, and the Department of Science and Technology’s Joint Administrative Order No. 2 (JAO), which sets out a regulatory framework for digital signatures backed by certificates from recognized trusted service providers and the promotion of the Public Key Infrastructure (PKI).

The E-Commerce Act defines an “electronic signature” as “any distinctive mark, characteristic and/or sound in electronic form, representing the identity of a person and attached to, or logically associated, with the electronic data message or electronic document or any methodology or procedures employed or adopted by a person and executed or adopted by such person with the intention of authenticating or approving an electronic data message or electronic document” (E-Commerce Act, Sec. 5(e)).

The REE defines a digital signature as “an electronic signature consisting of a transformation of an electronic document or an electronic data message using an asymmetric or public cryptosystem such that a person having the initial untransformed electronic document and the signer's public key can accurately determine: whether the transformation was created using the private key that corresponds to the signer's public key; and whether the initial electronic document had been altered after the transformation was made.” There is no official list of trusted third-party certification authorities. However, the Philippine government has an official PKI system, the Philippine National Public Key Infrastructure system.

Under the E-Commerce Act, only electronic signatures that satisfy the following conditions are valid:

1. The signature must comply with the definition of an electronic signature under the E-Commerce Act;
2. There must be a prescribed method of signing not alterable by the parties interested in the electronic document;
3. The method of signing must identify the party sought to be bound and indicate such party’s access to the electronic document necessary for his consent or approval through the electronic signature;
4. The method for signing is reliable and appropriate for the purpose for which the electronic document was generated in light of all circumstances including any relevant agreement;
5. It is necessary for the party sought to be bound, to proceed further with the transaction, to have executed or provided the electronic signature; and
6. The other party is authorized and enabled to verify the electronic signature and to make the decision to proceed with the transaction authenticated by the electronic signature.

To have the same presumption of enforceability and admissibility of a “wet” signature, electronic signatures must satisfy the above requirements. Accordingly, only an electronic document bearing a certificate-based digital signature verifiable through a trusted third party is recognized as the equivalent of a “wet” signature under Philippine law.

Failure to comply with the E-Commerce Act removes the presumption of enforceability and admissibility. However, electronic signatures that don’t comply with these requirements can still be used to prove the consent of an individual to the document that they signed electronically. An electronic or digital signature authenticated under the Supreme Court’s Rules on Electronic Evidence is admissible as the functional equivalent of the signature of a person on a written document.

Under the REE, an electronic or digital signature may be authenticated in any of the following ways:

1. By evidence that a method or process was utilized to establish an electronic signature or digital signature and verify the electronic signature or digital signature;
2. By any other means provided by law; or
3. By any other means satisfactory to the judge as establishing the genuineness of the electronic signature or digital signature.

When either an electronic or digital signature is authenticated under the REE, what are known as disputable presumptions arise. These are presumptions that are satisfactory for legal purposes until and unless they’re contradicted and overcome by other evidence. These include:

1. The electronic signature is that of the person to whom it correlates;
2. The electronic signature was affixed by that person with the intention of authenticating or approving the electronic document to which it is related or to indicate such person's consent to the transaction embodied therein; and
3. The methods or processes utilized to affix or verify the electronic signature operated without error or fault.
4. The digital signature is that of the person to whom it correlates;
5. The digital signature was affixed by that person with the intention of authenticating or approving the electronic document to which it is related or to indicate such person's consent to the transaction embodied therein;
6. The methods or processes utilized to affix or verify the digital signature operated without error or fault;
7. The information contained in a certificate is correct;
8. The digital signature was created during the operational period of a certificate;
9. No cause exists to render a certificate invalid or revocable;
10. The message associated with a digital signature has not been altered from the time it was signed; and,
11. A certificate had been issued by the certification authority indicated therein.

The courts are familiar with and take judicial notice of the laws governing electronic signatures.

7.9 Considerations/Requirements for Electronic Patient Reported Outcome (ePRO)

There is no regulation preventing the use of ePro in the Philippines, subject to RA/EC approval. 

7.10 Considerations/Requirements for Home Health Care (HHC) - Home Nursing

At-home nursing is commonplace in the Philippines, particularly for the elderly and disabled. There is no specific guidance around home nursing in clinical trials; this is subject to ethics approval.  

7.11 Considerations/Requirements for HHC - Home Lab Collection

There is no specific guidance around home lab collection for clinical trials.

7.12 Considerations/Requirements for Direct-to-Patient Study Product Delivery

There is no specific guidance around direct-to-patient study product delivery.

7.13 Considerations/Requirements for the Use of Telemedicine

There is no specific guidance on telemedicine in Clinical Trials. However, the Republic Act 11223 governs telemedicine in general.  

Republic Act No 11223, otherwise known as the Universal Healthcare Act, and its rules and regulations recognize the use of digital technologies for remote access and delivery of individual-based health services.  

In response to the increased use of telemedicine during the COVID-19 pandemic, the Philippine government has issued various regulations on telemedicine. Currently in effect is the Joint Administrative Order No 2021-001, issued by the DOH, Department of Interior and Local Government (DILG), and the Philippine Health Insurance Corporation (PhilHealth), which provides for the guidelines on the implementation of telemedicine in the delivery of individual-based health services ("Telemedicine Guidelines"). 

Under the Telemedicine Guidelines, "telemedicine" is defined as the delivery of health care services where distance is a factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment, prevention of disease and injuries, evaluation, and for the continuing education of healthcare providers, all in the interest of advancing the health of individuals and their communities.

Under the Telemedicine Guidelines, only licensed physicians are allowed to practice telemedicine. Moreover, the practice of telemedicine shall follow the standards of the practice of medicine as defined under the Medical Act and its rules and regulations, the Philippine Medical Association (PMA) Code of Ethics, and other applicable policies. Further, physicians shall observe the same standards of care as in face-to-face consultations but with the intrinsic limitations of telemedicine. 

Under the Telemedicine Guidelines, the minimum health services to be provided shall include medical diagnosis, health advice and counseling, issuance of electronic prescriptions, and/or referral. The nature of the individual-based health services and information shall be based on the service capability, mode of consultation, the purpose of consultation, timing of consultation, persons involved, specific conditions of the patient, and the localized standard telemedicine protocol. 

The Telemedicine Guidelines also provide that all telemedicine consultations by licensed physicians shall have proper documentation and all electronic consultation documents shall contain a digital signature, name, license number, and professional tax receipt (PTR), if applicable, of the issuing licensed physician. Further, all electronic prescriptions must contain the name of the patient to whom the medicines or drugs are prescribed, the name of the medicines and/or drugs prescribed, the dosage and all other pertinent details similarly contained in a written prescription. 

The Telemedicine Guidelines also provide for governing principles in the practice of telemedicine. These include the requirement for telemedicine consultations to allow both the patient and licensed physician to know, verify, and confirm each other’s identity at the start of the consultation. Proper informed consent must also be obtained from the patient prior to the collection of personal data and the offering of any telemedicine service. Further, it mandates that the principle of privileged communication between the licensed physician and the patient shall be observed at all times.

https://practiceguides.chambers.com/practice-guides/digital-healthcare-2023/philippines/trends-and-developments 

7.14 Considerations/Requirements for the Use of Wearables

Wearables/Health Apps as Medical Devices

Wearables such as fitness trackers may be classified as medical devices, depending on their intended use and how they are marketed to the public. 

A wearable or fitness app may be considered a medical device if it is intended for diagnosis, monitoring, treatment, or alleviation of a disease or injury. If the app's function is limited to measuring heart rate, blood pressure, or other health information, its intended use may not necessarily fall within the definition of a medical device. As such, wearables or apps used in such a manner may not be considered a medical device and therefore not subject to the regulatory requirements under DOH and FDA regulations. 

On the other hand, if the wearable or app is intended for medical purposes, including diagnosing an ailment or disease, monitoring certain health conditions, or treating any disease or injury, the wearable or health app may be classified as a medical device. As mentioned in this guidebook, an entity that intends to engage in the importation, marketing, sale, and distribution of medical device products must obtain an LTO from the FDA and the device must be covered by a CMDN or a CMDR, depending on its risk classification.  

If the wearable or health app is not classified as a medical device, it will not be subject to the regulatory jurisdiction of the FDA over health products, and its importation, distribution, marketing, and sale in the Philippines will be governed by general consumer protection laws applicable to all consumer products.

https://practiceguides.chambers.com/practice-guides/digital-healthcare-2023/philippines/trends-and-developments 

7.15 Considerations/Requirements for Remote Assessment/Monitoring

During the COVID-19 pandemic, the use of remote assessments became more common, but this is still not commonplace for other trials. 

7.16 Considerations/Requirements for Digital Health Technologies (such as Platforms)

There is no specific guidance around the use of digital health technology platforms.