mHealth

News & Analysis as of

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

Blog: Early 2015 Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. ...more

China Telemedicine Tackles Long Term Care: Business Opportunities and Government Guidance

This post is the fifth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market. A China government policy...more

Advertising Law - March 2015 #2

New DAA App Brings Choice to Mobile - Bringing consumer choice to mobile applications, the Digital Advertising Alliance released “AppChoices,” a free app that will allow consumers to opt out of tracking on mobile...more

Mobile Medical’s Validity Experts Get To Stay Behind The Wheel

As the established gatekeepers with respect to expert testimony, district courts have broad discretion on whether to admit or exclude such evidence. The Vermont district court recently opted to deny patentee defendant...more

Telehealth Bill Moving Forward in Florida-But Medicaid Coverage Sacrificed

Last week, the Florida Senate Health Policy Committee removed language from proposed telehealth legislation that would require Medicaid reimbursement for telemedicine services at the same rates as face-to-face examinations....more

EU Art. 29 Working Party Letter on Health Data and Apps

The EU Article 29 Working Party (“WP29”) has published a letter to the European Commission (“EC”) on the scope of health data in relation to lifestyle and well-being apps, following the EC’s Working Document on mHealth and...more

Alert: FDA Finalizes Guidance on Devices that Store and Transfer Data

The Food and Drug Administration (FDA) on February 6th, finalized guidance on certain medical devices that store and transfer data, opting for a very light regulatory touch. In its guidance, the FDA states that it doesn't...more

Regulatory Challenges Facing the mHealth Industry

Innovations in health care technology have created unique challenges for developers and investment companies. Among others, changing FDA guidelines, data security, and reimbursement are all substantial issues facing the...more

Is Your Mobile Health App HIPAA Compliant?

Mobile health apps (also known as mHealth apps) are increasingly popular with consumers. As of 2014, there were more than 100,000 mobile health apps available on iOS and Android platforms, and total revenue from mobile health...more

HHS to Address Lack of Clarity Regarding Mobile Health

A letter from the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights to Rep. Peter DeFazio (D-Ore.) signals an intent to move forward with providing clearer regulatory guidance relating to the Health...more

FDA Proposes Additional Flexibility for Mobile Health Products

Draft Guidances Address General Wellness Products and Device Accessories - The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more

FDA Proposes to Apply Risk-Based Framework to Accessory Devices

In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome...more

Telehealth, Health IT, and mHealth Policy: Considerations for Stakeholders

In recent months, as the conversation about reforming the health care system has shifted from websites and coverage expansion to achieving greater delivery system efficiencies, cost containment, and quality improvement, the...more

Mobile Health Apps are in a Boom Phase – Why is it so Hard for Pharmaceutical Companies to Find Users?

Mobile medical and health applications have been in a boom phase for the past few years, but despite this trend, one group of entities has had trouble breaking into the mobile medical app sphere, pharmaceutical (i.e., pharma)...more

mHealth Technology – Development in an Uncertain Regulatory Climate

The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies...more

Three Things Tech Titans Have That eHealth Needs

Large tech companies have been virtually lining up to announce their foray into the digital health space recently. Industry analysts have long suspected that an incumbent industry with a strong customer base could come in and...more

FDA Draft Guidance Would Ease Regulatory Burdens for Certain mHealth Applications

On August 1, 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices--including certain mobile applications that can convert a cell...more

Capital Thinking: Technology and Communications

Legislative Activity - House Commerce SUBCommittees Will Hold Hearing ON 21st Century Technology for 21st Century Cures - The House Energy and Commerce Subcommittees on Communications and Technology and Health...more

AMA Adopts Telemedicine Policy for Coverage and Payment of Telemedicine Services

During its Annual Meeting on June 11, 2014, the American Medical Association (AMA) voted to approve a list of guiding principles for coverage of and payment for telemedicine services, designed to “foster innovation in the use...more

Digital Health Investments Rack up Another Impressive Month in May

Digital Health investment in May totaled $691 million, down from the impressive $924 million netted in April. The nearly $700 million in new capital, however, compares favorably to the $421 million taken in in March and shows...more

What are anonymous data?

Problems relating to what data/images/information can be consider anonymous is one of the major data protection issues of privacy law having an impact in any sector including the Internet of Things, eHealth and on any...more

Draft Guidelines for TeleICU Operations Released

The American Telemedicine Association released draft Guidelines for TeleICU Operations on March 28, 2014 and is seeking public comments through April 26, 2014. Practice guidelines can serve as a useful reference point...more

Digital Health Investments Heat Up In 2014

Fundraising for digital health continued on its record pace in February with more than $320 million in venture, debt and private equity investment going into the burgeoning sector....more

When Is An iPad More Than An iPad? When It Is An FDA Regulated Medical Device

In the late 1980s, the Food and Drug Administration (FDA) began publicly suggesting that electronic medical records were within its jurisdiction. A lot has changed in 20+ years. The proliferation of mobile computing platforms...more

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