Archives: Consumer Protection

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False Claims Act Settlement with eClinicalWorks Raises Questions for Electronic Health Record Software Vendors

On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate Integrity Agreement to resolve allegations that it caused its customers to submit false claims for Medicare and Medicaid meaningful use payments … Continue Reading

Recent $2.5 Million OCR Settlement Is a Warning to Wireless Health Service Providers

On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement in the amount of $2.5 million based on the impermissible disclosure of unsecured electronic protected health information (ePHI) by a provider of remote mobile monitoring, with … Continue Reading

Guide from the Italian Data Protection Authority on the Application of the GDPR: Recommendations on How to Get Started!

On April 28, 2017, the Italian Data Privacy Authority published a Guide on the application of the new General Data Protection Regulation (GDPR). The Guide does not set out implementing rules of the GDPR but rather provides a summary of “what will remain the same” and “what will change” in the main six areas covered … Continue Reading

More Federal Legislation Aimed at Expanding Medicare Coverage of Telehealth Services

Late last month, Senator Cory Gardner (R-CO) and Senator Gary Peters (D-MI) introduced Senate Bill 787, the Telehealth Innovation and Improvement Act (Telehealth Improvement Act), which is focused on expanding Medicare’s currently limited coverage of telehealth services and opportunities for innovation. The Telehealth Improvement Act would require the Center for Medicare and Medicaid Innovation (CMMI) … Continue Reading

New York AG Settlement with App Developers Serves as a Warning for the Need for Evidence-Backed Commercial Claims

On March 23, 2017, the New York Attorney General’s office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims. This settlement highlights for mHealth app developers the importance of systematically gathering sufficient evidence to support their commercial claims. Read the full … Continue Reading

The TCPA: An Unexpected Deterrent to Patient Engagement Tools

In an age where providers are increasingly taking the management of their patient’s health online and out of the doctor’s office, the creation of scalable and nimble patient engagement tools can serve to improve patient experience, health care outcomes and health care costs. While the level of enthusiasm for these tools is at an all-time … Continue Reading

End of Year Attention to Health IT and Digital Health Tools in 21st Century Cures

On December 7, 2016, the US Congress approved the 21st Century Cures Act (Cures legislation), which is intended to accelerate the “discovery, development and delivery” of medical therapies by encouraging public and private biomedical research investment, facilitating innovation review and approval processes, and continuing to invest and modernize the delivery of health care. The massive … Continue Reading

OCR Explains How Information Blocking Violates HIPAA

The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently posted guidance (OCR guidance) clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a covered entity customer to protected health information (PHI) maintained by the vendor on behalf of the … Continue Reading

Guidance on Ransomware Attacks under HIPAA and State Data Breach Notification Laws

On July 28, 2016, US Department of Health and Human Services (HHS) issued guidance (guidance) under the Health Insurance Portability and Accountability Act (HIPAA) on what covered entities and business associates can do to prevent and recover from ransomware attacks. Ransomware attacks can also trigger concerns under state data breach notification laws. The HIPAA Security … Continue Reading

Guidance on Low Risk General Wellness Devices Is Finalized

On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory requirements for low risk products that promote a healthy lifestyle—coined “general wellness products.” In the Final Guidance, the FDA makes minimal substantive changes to … Continue Reading

AMA Approves New Ethical Guidance Policy and Encourages Telemedicine Training for Students and Residents

New Ethical Guidelines On June 13, the American Medical Association (AMA) adopted a new ethical guidance policy governing the practice of telemedicine that will be published in the coming months. The policy is based on a report from the AMA Council on Ethical and Judicial Affairs and builds upon the AMA’s 2014 telemedicine guidance. Consistent … Continue Reading

Louisiana Joins its Peers in Removing In-State Barriers to Telemedicine

Last week, Louisiana legislators approved the removal of certain restrictions on the delivery of telemedicine services to residents of Louisiana to encourage the provision of telemedicine services in the state.  H.B. No. 570 was signed by the President of the Senate on June 5, 2016 and sent to Governor John Bel Edwards on June 6, … Continue Reading

Mobile Health Tools, Developers Need Better Data Protection Guidance, Attorney Jennifer Geetter Says

After three government agencies collectively created an online tool to help developers navigate federal regulations impacting mobile health apps, McDermott partner Jennifer Geetter was interviewed by FierceMobileHealthcare on the need for mobile health development tools. Read the full article from FierceMobileHealthCare.… Continue Reading

FTC Weighs-in on Telehealth: Providing Comments Regarding Alaska’s Proposed Licensure and Standard of Care Requirements

In March 2016, the US Federal Trade Commission (“FTC”) staff submitted public comments regarding the telehealth provisions of a proposed state bill in Alaska demonstrating the FTC’s continued focus on health care competition and general discouragement of anti competitive conduct in health care markets, with a renewed interest and focus on telehealth.… Continue Reading

Developing and Implementing an Effective Telemedicine Informed Consent Form

The search by consumers, payers and providers for more efficient, effective and convenient care delivery models has led to an explosion of technological innovation in the health care sector. This explosion has supported the increased use of telemedicine by providers to reach patients who were previously out of reach, and to provide more timely and cost-effective … Continue Reading

Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps that collect, create and share consumer information, including health information. The interactive series of questions and answers augments and cross-references existing … Continue Reading

Farewell ‘Safe Harbor,’ Hello ‘Privacy Shield’: Europe and U.S. Agree on New Rules for Transatlantic Data Transfer

After intense negotiations, and after the official deadline had passed on Sunday, 31 January 2016, the United States and the European Union have finally agreed on a new set of rules—the “EU-U.S. Privacy Shield”—for data transfers across the Atlantic. The Privacy Shield replaces the old Safe Harbor agreement, which was struck down by the European Court … Continue Reading

FTC Report Alerts Organizations about the Risks and Rewards of Big Data Analytics

On January 6, the Federal Trade Commission (FTC) released a report that it hopes will educate organizations on the important laws and research that are relevant to big data analytics. The report, Big Data: A Tool for Inclusion or Exclusion? Understanding the Issues, looks specifically at how big data is used after it is collected … Continue Reading

China Released the Latest Classification Catalogue of Telecommunications Services (2015 Revision)

On December 28, 2015, the Ministry of Industry and Information Technology of China released the newly revised Classification Catalogue of Telecommunications Services, which is due to take effect as of March 1st, 2016. This round of revision has long been awaited since its last amendment in 2003, and is expected to reflect the advancement and … Continue Reading

States Begin 2016 with the Expansion of Telehealth Services

As we enter into the new year, the health industry continues to see expanded access to telehealth services.  After a whirlwind 2015 in which we saw over 200 telehealth-related bills introduced in 42 states, New York and Connecticut emerge as the first states in 2016 to implement laws that expand patients’ access to telehealth services. … Continue Reading

FTC Sees Disconnect on Proposed Connected Cars Legislation

The Energy & Commerce Committee of the U.S. House of Representatives held a hearing on October 21st titled “Examining Ways to Improve Vehicle and Roadway Safety” to consider (among other matters) Vehicle Data Privacy legislation for internet-connected cars. The proposed legislation includes requirements that auto manufacturers: “Develop and implement” a privacy policy incorporating key elements … Continue Reading

Safe Harbor Update: House Votes to Pass Judicial Redress Act

The Judicial Redress Act of 2015 (H.R. 1428) (Judicial Redress Act) is on its way to the U.S. Senate. On October 20th, the U.S. House of Representatives voted in favor of passage. The Judicial Redress Act extends certain privacy rights under the Privacy Act of 1974 (Privacy Act) to citizens of the EU and other … Continue Reading

Employee consent to use of personal data reliable under German law

The German Federal Labor Court (Bundesarbeitsgericht (BAG)) has published the reasons for its two decisions about whether an employee can revoke consent given to his or her employer for public use of the employee’s image in photos, videos or other marketing materials (BAG 19 February 2015, 8 AZR 1011/13; BAG 11 December 2014 – 8 … Continue Reading

Court of Justice of the European Union Says Safe Harbor Is No Longer Safe

Earlier today, the Court of Justice of the European Union (CJEU) announced its determination that the U.S.-EU Safe Harbor program is no longer a “safe” (i.e., legally valid) means for transferring personal data of EU residents from the European Union to the United States. The CJEU determined that the European Commission’s 2000 decision (Safe Harbor … Continue Reading
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