Digital Health – The Regulatory Landscape

Jerusalem, June 29th, 2015

Gadi Ginot, CEO

This presentation is the sole property of Physio-logic Ltd and is protected by Copyright ©. Any use of this presentation without the prior written approval of Physio-Logic Ltd is prohibited. This presentation does not constitute regulatory advice and should not be regarded as replacing professional consultation. We recommend that you receive specific professional advice in relation to any regulatory matter.

Did you know that:

• Average attention span has dipped to a low 8 seconds – down from 12 seconds in 2000.

• A goldfish has an attention span of 9 seconds…

• Nearly three quarters of professionals tune out of presentations within the first minute, stop reading an email after 30 seconds, and stop listening to colleagues after 15 seconds….

10 Minutes Overview…

*How does digital affect Canadian attention span?

The whole “Toraha” on One Leg

Teach me the whole Torah while standing on one leg.

Shammai gives the man an angry whack with a measuring rod.

Hillel replies: “That which is hateful to you, do not unto another: This is the whole Torah. The rest is commentary — [and now] go study.”

Risk Based Approach Towards Regulation of eHealth Risk (privacy, hacking, injury, miss-diagnosis, delay of

treatment, misuse, error) Functionality focused (administrative,

medical device etc.) Narrowly tailored

To Make a Long & Never Ending Story Short

FDA Applies a Risk Based Approach in Deregulating Digital Health Products

But…

Regulation is always behind technology

Ambiguity and lack of clarity Inconsistency Compliance - FCC cracks down on misbranded Apps

While FDA makes effort to portray expectations, the demarcation between FDA regulated product vs. nonregulated is complex and tricky at times.The ramifications of this demarcation are extensive!

Your Chances of Figuring it Out Right are Slim

FDA Regulated vs. Non-Regulated MDDS“The success of digital health “requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software that transfer, store, convert formats, and display medical device data or medical imaging data.”

MDDS Final Guidance (Feb 9, 2015): FDA does not intend to enforce compliance, But MDDS does not include:

• Products intended for active patient monitoring i.e. clinical context requires a timely response The clinical condition (disease or diagnosis) requires

a timely response

• Modifies the medical device data, and

• Control the functions or parameters of any connected medical device

FDA Regulated vs. Non-Regulated Apps

MMA Final Guidance (Feb. 2015) – Apps that meets FDA device definition that are either intended to act as:

• Accessory to regulated medical device; or• Transform a mobile platform into a regulated medical

device• Used for purposes of controlling the device(s) or use in

active patient monitoring or analyzing medical device data

FDA Regulated vs. Non-Regulated Wearables

General Wellness Guidance (Feb. 2015) – Hands Off Approach for product:• Intended for only general wellness use, and• Inherently present a very low risk to users’ safety.• Without any reference to diseases or conditions, or

with a disease-related general wellness claims that contain references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition

Risk-based classification for accessories allowing for a de novo submission

Clarity is seriously Lacking for the EU

European Commission digital strategy and agenda for 2012 with targets for 2020

The second eHealth Action Plan 2012-2020

Little to no guidance for manufacturers

Single recent guidance document on standalone Sw

Not well addressed in on-going discussion on the Medical Device Recast

Regulation Goes Beyond FDA

FCC, RTTE

HIPPA (Privacy, Security)

EC Privacy directive (95/46/EC)

Cybersecurity

ISO 9001, ISO13485

CE Marking Directives

ISO/IEC Health IT Standards

Take Home Messages

Functionality and risk will dictate to what extent your health IT product be regulated

Lack of clarity make it challenging to navigate the regulatory maze at this time

Consult and develop defensible regulatory strategy

Turn regulation from necessary evil to competitive advantage

And the rest is commentary…..

Our Digital Health Experts At Your Disposal

SMEs on board: HW & SwQA HIPPA experts Cybersecurity team Usability experts FDA 510(k), CE Mark ISO13485, ISO9001

Thanks!

Gadi Ginot:

gadi@physio-logic.co.il

050-8317449

www.physio-logic.co.il