News

mHealth and Emerging Technologies

Mobile Health and Health IT are revolutionizing the healthcare industry. From Electronic Health Records (EHRs) that coordinate patient care to mobile applications and tools that aid diagnosis, monitor symptoms, and track compliance with medications. Healthcare technology is rapidly changing established healthcare delivery models and the rules that govern them. These changes will impact cross-border regulations, policies, and best practices in many areas, including regulatory licensing and approval, quality and safety, coverage and reimbursement, market access, healthcare compliance, advertising and promotion, privacy and data security, and litigation and risk management. The mHealth and Emerging Technologies Group at Arnold & Porter combines diverse subject-matter experience, deep industry knowledge, international perspectives, and innovative problem-solving to help our clients navigate the complex legal and regulatory issues in this thriving and constantly evolving industry.

Perspectives

MedTech Europe requests extension to the transition period for the MDR
BioSlice Blog
Lesson Learnt from the UK Information Commissioner's Ruling Against Royal Free NHS Foundation Trust and its Impact on Partnership and Collaboration in Artificial Intelligence Research
Digital Health Download
Commission Working Group on mHealth Assessment Guidelines Issues its Report — and it's Inconclusive
Digital Health Download
WP29 Reviews the European Draft Code of Conduct on Privacy for Mobile Health Apps
Digital Health Download
Not Enough: FDA Finds Ongoing Cybersecurity Vulnerabilities with St. Jude Medical’s Implantable Cardiac Devices
Digital Health Download
Safety of Online Primary Care in the UK: The CQC Brings Forward Its Inspection Programme
Digital Health Legal
Big Data: Big Balancing Act?
Digital Health Download
eHealth Standards for Europe
Digital Health Download
New York Attorney General Enters Settlement with Three mHealth App Developers
Digital Health Download
Clinical Trial Consent: There Is an App for That
Digital Health Download
A Busy Start to the (Data Protection) Year!
Digital Health Download
NICE to Introduce HTA-Style App Assessment Process from March 2017
Digital Health Download
What's the Deal With Watson? Artificial Intelligence Systems and Medical Software Regulation in the US and EU
Digital Health Download
Launch of EURO-CAS: eHealth Interoperability Takes Center Stage
Digital Health Download
Results of the European Commission Consultation on the Safety of Apps
Digital Health Download
FDA Finalizes Medical Device Postmarket Cyber Guidance—Interesting Implementation Choices to Come!
Digital Health Download. Published in Privacy & Cybersecurity Law Report's April 2017 issue.
FTC Report Highlights Privacy Concerns Associated with Cross-Device Tracking
Digital Health Download
U.S. Antitrust Enforcers Weigh-In on Competitive Benefits of Telehealth
Digital Health Download
Clinical Trials: Is There An App For That?
Digital Health Download
FDA Unveils New Website for Anonymous Reporting of Regulatory Violations
Digital Health Download
Congress Directs HHS to Convene a Cybersecurity Task Force
Digital Health Download
FTC to Lumos: Our Substantiation Standards Ain’t a Game
Digital Health Download
FCC Seeks Comment on Major Reforms to the Rural Health Care Program
Digital Health Download
Congress Provides Relief from Meaningful Use Penalties, With Some Strings Attached
Digital Health Download
A Teladoc Win for Telehealth
Digital Health Download
Recent Patent Trial and Appeal Board Decision Questions the Patentability of Health IT Data Encryption Technology
Digital Health Download
MIT's Hacking Medicine Institute Is Gonna Find Out Which Digital Health Tools Are Naughty And Nice
Digital Health Download
Hello…Can You Hear Me? Hackers Can Now Access Personal Information Through Children's Toys
Digital Health Download
precisionFDA: An Opportunity for Labs to Demonstrate Value of Next-Generation Sequencing
Digital Health Download
FDA Cites iPhone App for Design Validation Failure
Digital Health Download
FDA Looking at Gaps in the Cybersecurity of Medical Devices
Digital Health Download
Giving the Gift of EHRs--Or is That a Kickback
Digital Health Download
Will FDA Incorporate mHealth into Clinical Trials
Digital Health Download
ADHD Software Under FDA Scrutiny
Digital Health Download
Inspecting FDA’s Oversight of Hospitals’ Networked Medical Devices: OIG’s 2016 Work Plan
Digital Health Download
FTC Loses Case Involving Security of Laboratory's Customer Data
Digital Health Download
FCC Announces Medical Body Area Network (MBAN) Frequency Coordinator, Clearing the Path for Use of MBAN Equipment
Digital Health Download
Meaningful Use Prepares to Take a Bow… and then an Encore
Digital Health Download
Study Exposes Shortcomings in Data Security of Health Apps on NHS Choices Platform
Digital Health Download
The EU Directive on Cross-Border Healthcare: A Watershed for Harmonised Patient Access?
Digital Health Download
Managing Litigation and Compliance Risks: Are mHealth and Health IT the New Frontier for Product Liability and Enforcement?
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