FDA 21st century cures act's implications on digital health

1. Shosh Friedman, RAC, FRAPS – March 2018 1
FDA 21st Century Cures Act
Implications on Digital Health
Shoshana (Shosh) Friedman, RAC, FRAPS
CEO of ProMedoss, Inc.
Connected Medical Devices Meetup, April 2019

2. 2Shosh Friedman, RAC, FRAPS – April 2019
What is digital health?
 “Digital health is the convergence of the Digital and
Genomic Revolutions with health, healthcare, living, and
society.”
Or, simply put:
 Digital health is the application of digital technology to
our health and wellness.
 Per FDA, digital health scope includes categories such as
mobile health (mHealth), health information
technology (IT), wearable devices, telehealth,
telemedicine, ….

3. 3Shosh Friedman, RAC, FRAPS – April 2019
FDA’s Digital Health Concept

4. 4Shosh Friedman, RAC, FRAPS – April 2019
FDA’s Digital Health Criteria
 Software as a Medical Device (SaMD)
 Advanced Analytics
 Artificial Intelligence
 Cloud
 Cybersecurity
 Interoperability
 Medical Device Data System (MDDS)
 Mobile Medical App (MMA)
 Wireless
 Novel Digital Health

5. 5Shosh Friedman, RAC, FRAPS – April 2019
FDA’s Digital Health Criteria -
Examples
 Software as a Medical Device (SaMD) - Software that analyzes
heart rate data intended for a clinician as an aid in diagnosis of
arrhythmia
 Advanced Analytics - Software that uses data from a standard CT
to create a personalized 3D model of the coronary arteries and
analyzes blockages
 Artificial Intelligence - Smart ECG that estimates the probability of
acute cardiac ischemia
 Cloud - Mobile colposcope that stores images taken on the cloud
for future retrieval and review in the doctor’s office
 Cybersecurity - Limited access to devices or products through the
authentication of users (e.g. user ID and password, smartcard,
biometric)

6. 6Shosh Friedman, RAC, FRAPS – April 2019
FDA’s Digital Health Criteria -
Examples
 Interoperability - Infusion pump that receives patient data from a
pulse oximeter and uses this data to change infusion pump
settings
 Medical Device Data System (MDDS) - Software that converts
digital data generated by a pulse oximeter into a digital format
that can be printed
 Mobile Medical App (MMA) - Mobile app that transforms the
mobile device into a glucometer
 Wireless – Imaging capsule that sends images to the external
recorder
 Novel Digital Health - Wearable or implanted wireless device

7. 7Shosh Friedman, RAC, FRAPS – April 2019
 Since 2013, FDA has been refining its policies to
address the new challenges introduced by DH.
 Taking a practical attitude towards overseeing
DH products with emphasis on risk-based
approach as the foundation of the regulatory
framework.
FDA’s Actions & Policies on DH

8. 8Shosh Friedman, RAC, FRAPS – April 2019
FDA’s DH Actions & Policies
Focus on what
the product
does, not on
how it looks
like
Focus on
higher risk
technologies,
not on all
technologies

9. 9Shosh Friedman, RAC, FRAPS – April 2019
21st Century Cures Act
codified some of these
policies
FDA’s DH Actions & Policies

10. 10Shosh Friedman, RAC, FRAPS – April 2019
21st Century Cures Act
 Signed into law on December 13, 2016
 Designed to:
 Promote and fund the acceleration of research into
preventing and curing serious illnesses
 Accelerate drug and medical device development
 Attempt to address the opioid abuse crisis
 Improve mental health service delivery

11. 11Shosh Friedman, RAC, FRAPS – April 2019
• Section 3038: Combination Products
• Section 3051: Breakthrough Devices
• Section 3052: Humanitarian Device Exemption (HDE)
• Section 3053: Recognition of Standards
• Section 3054: 510(k) Exemptions for Class I/II Devices
• Section 3055: Classification Panels
• Section 3056: Institutional Review Board (IRB)
• Section 3057: CLIA Waiver
• Section 3058: Least Burdensome Device Review
• Section 3059: Cleaning Instructions and Validation
• Section 3060: Clarifying Medical Software Regulation
21st Century Cure
Medical Device Related Sections

12. 12Shosh Friedman, RAC, FRAPS – April 2019
 Five categories of low-risk software and certain Clinical
Decision Support (CDS) software are out of FDA
jurisdiction
 Mobile apps are exempt if unrelated to the
diagnosis/prevention of diseases.
 Accessories are classified based on their intended use
Section 3060: Clarifying Medical Software
Regulation

13. 13Shosh Friedman, RAC, FRAPS – April 2019
The five categories of software:
1. Administrative support of healthcare facility (keeping
records, business analytics, etc.)
2. Maintaining/ encouraging healthy lifestyle (unrelated
to diagnosis/treatment of a disease/condition)
 Codifies FDA position on low risk devices for general wellness
Section 3060: Clarifying Medical Software
Regulation

14. 14Shosh Friedman, RAC, FRAPS – April 2019
3. Serves as electronic patient records. As long as:
 Records are created/handled by healthcare professionals, or
under their supervision
 Such records are part of health information technology that is
certified under section 3001(c)(5) of the Public Health Service
Act (=HIPAA)
 Function is not intended to interpret/analyze patient records
(including medical image data) for purpose of
diagnosis/treatment of disease or condition
Section 3060: Clarifying Medical Software
Regulation

15. 15Shosh Friedman, RAC, FRAPS – April 2019
4. Products meeting the definition of either a medical device
data system (MDDS) or a laboratory information system
(LIS).
 Codifies FDA position on exercising enforcement discretion not to
regulate MDDS.
 Changes previous FDA approach of LIS being 510(k)-exempt Class I
subject to the quality system regulation to LIS not being subject to the
QSR or any other regulatory requirements.
Section 3060: Clarifying Medical Software
Regulation

16. 16Shosh Friedman, RAC, FRAPS – April 2019
5. Clinical decision support (CDS) for the purpose of:
 displaying, analyzing, or printing medical information about a patient or
other medical information (such as peer-reviewed clinical studies and
clinical practice guidelines);
 supporting or providing recommendations to a healthcare professional
about prevention, diagnosis, or treatment of a disease or condition; and
 enabling such healthcare professional to independently review the basis
for recommendations the software presents so that it is not the intent
that such healthcare professional rely primarily on any of such
recommendations to make a clinical diagnosis or treatment decision
regarding an individual patient
Section 3060: Clarifying Medical Software
Regulation

17. 17Shosh Friedman, RAC, FRAPS – April 2019
 Preserves FDA’s regulation of certain devices like computer
assisted detection/diagnosis (CAD) that analyze image data
(e.g., identifying suspicious lesions in a CT scan) and in
IVDs.
 Allows FDA to bring certain excluded software back under
its jurisdiction based on findings suggesting the risks
associated with that software are higher than initially
thought.
Section 3060: Clarifying Medical Software
Regulation

18. 18Shosh Friedman, RAC, FRAPS – April 2019
 This section also includes a provision regarding
classification of accessories, stating that accessories must
be classified according to the intended use of the accessory,
rather than the intended use of the parent device.
 This provision codifies FDA policy presented in a draft guidance
from 2015
Section 3060: Clarifying Medical Software
Regulation

19. 19Shosh Friedman, RAC, FRAPS – April 2019
 On June 2017, FDA issued “Proposed FDA Work Plan for
21st Century Cures Act Innovation Account Activities”
describing activities and budget for each section of the Act.
FDA Implementation of Section 3060

20. 20Shosh Friedman, RAC, FRAPS – April 2019
 FDA announcements
FDA Implementation of Section 3060

21. 21Shosh Friedman, RAC, FRAPS – April 2019
 On December 2017 issued three guidance documents:
 “Changes to Existing Medical Software - Policies Resulting
from Section 3060 of the 21st Century Cures Act” (draft)
 “Clinical and Patient Decision Support Software” (draft)
 “Software as a Medical Device (SAMD): Clinical
Evaluation” (final)
FDA Implementation of Section 3060

22. 22Shosh Friedman, RAC, FRAPS – April 2019
FDA Implementation of Section 3060
 On July 27, 2018 the FDA announced the ”Digital Health
Innovation Action Plan”

23. 23Shosh Friedman, RAC, FRAPS – April 2019
Digital Health Innovation Action Plan

24. 24Shosh Friedman, RAC, FRAPS – April 2019
FDA’s Vision of DH Paradigm Shift

25. 25Shosh Friedman, RAC, FRAPS – April 2019
Tips for Developers of DH Tools
 First question to ask: Will my DH tool be regulated as a
medical device?
 But remember a common misconception that DH is purely a
device
 What about DH tool used in combination with an approved
drug or an electronic pill that releases drug in response to
smartphone command?
 So a second question to ask: Does my DH tool implicate
another FDA-regulated product?

26. 26Shosh Friedman, RAC, FRAPS – April 2019
Tips for Developers of DH Tools
 Before making a final decision on whether or not your DH tool
be regulated by FDA as a medical device, ask the following
questions:
 What is the intended user and the intended use environment of my
DH tool?
 Is my DH tool intended to support clinical judgment of a healthcare
professional? If so, can he/she review the basis for the
recommendation?
 If my DH tool is for non-professional use, what is the likelihood my DH
tool will cause harm to the user? And, if harm to the user can happen,
how severe will it be?

27. 27Shosh Friedman, RAC, FRAPS – April 2019
Questions?

28. 28Shosh Friedman, RAC, FRAPS – April 2019
Thank You!