Lisa Clark

Lisa Clark

Duane Morris LLP

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mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary...more

2/12/2014 - FCC FDA FTC Healthcare HHS Medical Devices mHealth Mobile Apps Patents Telemedicine

Mobile Medical Apps Guidance

Mobile health ("mHealth") application ("app") developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration ("FDA") published its...more

10/7/2013 - FDA Mobile Apps Mobile Devices Telemedicine

FDA Draft Guidance Details Key Cybersecurity Management Measures Expected in Medical Device Submissions

Last month, the U.S. Food and Drug Administration (FDA) issued its Draft Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Recognizing the increasing need for effective...more

7/18/2013 - Cybersecurity FDA Medical Devices Mobile Devices Risk Management

WellPoint Pays HHS $1.7 Million to Settle HIPAA Security Violations

Covered Entities Cautioned Regarding Use of Business Associates - On July 8, 2013, health insurer WellPoint, Inc. entered into a Resolution Agreement with the U.S. Department of Health and Human Services, Office for...more

7/16/2013 - HHS HIPAA Policy Violations Settlement WellPoint

HIPAA Marketing and Sale Provisions: Legal Potholes for Providers, Payors, Advertisers, Data Aggregators, Market Researchers and...

HIPAA Marketing and Sale Provisions Under HIPAA - The privacy and security standards under the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and its regulations (the "HIPAA Rules") were designed...more

4/22/2013 - Advertising Business Associates Content Aggregators Covered Entities Healthcare HIPAA HITECH Marketing PHI

What the New HIPAA Rules Say About Health Information Technology for Users, Developers and Investors

Health Information Technology Under HIPAA - Central to healthcare reform efforts is the use of health information technology ("HIT"), a broad term that is often used in conjunction with electronic health records...more

3/13/2013 - Business Associates Data Protection Health Information Technologies HHS HIPAA Notice Requirements PHI

New HIPAA Rules Regarding Genetic Information Affect Employers, Group Health Plans, Health Insurers and Healthcare Providers

Genetic Information Under HIPAA - While the final rule supplementing and modifying the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, Breach Reporting and Enforcement Rules—78 Fed. Reg....more

2/26/2013 - Employer Group Health Plans Genetic Services GINA Health Insurance HHS HIPAA long Long-Term Care Medicare Underwriting

HIPAA Minimum Necessary Standard Should Be Key Component of Policies and Procedures, Now More Than Ever

On January 17, 2013, the U.S. Department of Health and Human Services ("HHS") announced the final omnibus rule amending the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") in accordance with the HITECH...more

2/11/2013 - Business Associates Covered Entities Data Breach Data Protection HHS HIPAA HIPAA Omnibus Rule HITECH Notifications PHI

Overview of 2013 Amendments to HIPAA Privacy, Security, Breach Notification and Enforcement Rules

On January 17, 2013, the federal Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR"), issued the long-anticipated final omnibus amendments (the "2013 Amendments") to the Privacy, Security, Breach...more

1/30/2013 - Business Associates Covered Entities Data Protection Electronic Medical Records Enforcement HIPAA HIPAA Omnibus Rule HITECH Medical Records Notice Requirements Patient Privacy Rights PHI

New HIPAA Breach Notification Rule May Prove Costly for HIPAA-Covered Entities

On January 17, 2013, the U.S. Department of Health and Human Services (HHS) announced a final omnibus rule amending the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in accordance with the HITECH Act of...more

1/28/2013 - Business Associates Covered Entities Data Breach Data Protection Electronic Medical Records HIPAA HIPAA Omnibus Rule HITECH Notifications PHI

Final HIPAA Amendments Expand HIPAA Net: Business Associates Now Required to Enter into Business Associate Agreements with...

On January 17, 2013, the federal Department of Health and Human Services (HHS) announced a final omnibus rule amending the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in accordance with the HITECH Act...more

1/23/2013 - Business Associates Covered Entities Data Protection Electronic Medical Records HHS HIPAA HIPAA Omnibus Rule HITECH Medical Records Patient Privacy Rights

FCC Releases Decision on New Funding Program for Rural Health: Broadband Connectivity Prioritized and the Expansion of...

Federal Communications Commission (FCC; the "Commission") decision making continues to be active in the area of telemedicine. Recently, on December 21, 2012, the agency released a lengthy decision updating its rules and...more

1/3/2013 - Broadband Digital Health FCC Healthcare mHealth Rural Health Care Program Telemedicine

The P's & Q's of mHealth and Patient Engagement; Privacy and Security Issues

Orginally published in mHealth Newsletter on November 14, 2012. "Patient engagement is the holy grail of healthcare," according to one hospital executive. Indeed, there is real money in the development of products and...more

11/15/2012 - Digital Health Electronic Medical Records FTC Healthcare HIPAA HITECH mHealth Mobile Apps PHI

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