Sharon Klein

Sharon Klein

Pepper Hamilton LLP

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Software as a Medical Device: FDA Releases Draft Guidance

Companies that develop software that functions as a medical device should be aware that the Food and Drug Administration (FDA) has issued draft guidance that, once finalized, will classify the endless variety of Software as a...more

11/9/2016 - Comment Period Draft Guidance FDA Healthcare Medical Devices Mobile Apps Mobile Medical Applications Software

California Attorney General 'Crowdsources' Reporting of Privacy Policy Violations

This initiative by the Attorney General is effective immediately and is just the latest example of California’s effort to increase enforcement of laws aimed at protecting the privacy and data security of individual consumers....more

10/20/2016 - Attorney Generals CalOPPA Data Security Internet of Things Mobile Apps Mobile Health Apps Online Platforms Personally Identifiable Information Policy Violations Popular Posting Requirements Privacy Policy Websites

The European Commission Formally Adopts the Privacy Shield

The Privacy Shield heightens the level of scrutiny and the burden on organizations that voluntarily self-certify. On October 6, 2015, the Court of Justice of the European Union invalidated the European Commission’s (the...more

7/26/2016 - Article 29 Working Party (WP29) Data Protection Authority Department of Transportation (DOT) EU EU-US Privacy Shield FTC International Data Transfers Personal Data U.S. Commerce Department

[Webinar] Data Protection Update: Joint Webinar with Travers Smith - March 9th, 12:00pm (EST) | 9:00am (PST)

The demise of the EU-US safe harbor arrangement has been bad news for many businesses in the US and the UK. A new "EU-U.S. Privacy Shield" deal in principle has just been announced as the replacement to the safe harbor but it...more

2/24/2016 - Cybersecurity Data Protection EU EU Data Protection Laws EU-US Privacy Shield Popular Safe Harbors UK US-EU Safe Harbor Framework Webinars

U.S. and EU Authorities Announce New Privacy Shield for Data Transfers

Companies should still ensure that they are lawfully transferring data through an alternative mechanism until the details of the Privacy Shield are released. The U.S. Department of Commerce and the European Commission...more

2/5/2016 - Article 29 Working Party (WP29) CJEU EU EU-US Privacy Shield FTC International Data Transfers Personal Data Safe Harbors Schrems v Data Protection Commissioner

HR Data Security in the Spotlight

Cloud computing has the potential to provide on-demand efficiency, lower costs and flexibility for HR functions. However, it is important to manage a number of data privacy and security issues to protect sensitive HR data in...more

11/18/2015 - Cloud Computing Cyber Insurance Data Breach Data Security Personal Data Popular

EU Court of Justice: Safe Harbor Decision Permitting EU-U.S. Personal Data Transfers Is Invalid

Ruling affects approximately 5,000 U.S. companies that have relied on the Safe Harbor to transfer personal data from the EU to the United States. Key Points - - The approach of the U.S. government to personal...more

10/7/2015 - Cybersecurity Data Protection Data Security Data Transfers European Court of Justice (ECJ) Facebook International Data Transfers NSA Privacy Laws Safe Harbors US-EU Safe Harbor Framework

Advocate General of the EU Court of Justice: EU-U.S. Safe Harbor Act Is Not Safe for EU Citizens

The decision could affect the thousands of U.S. companies in diverse industries that rely on the EU-U.S. Safe Harbor Agreement to legally transfer personal data of EU citizens from the EU to the United States....more

9/25/2015 - Advocate General Cybersecurity Data Privacy Data Protection Data Security Data Transfers Edward Snowden EU Data Protection Laws European Court of Justice (ECJ) NSA Personal Data PRISM Program Safe Harbors US-EU Safe Harbor Framework

9th Circuit Holds No Private Right of Action for Data Retention Violation Under the Video Privacy Protection Act

The decision further aligns the circuit courts in holding that the private right of action is limited to the Act’s prohibition on unauthorized disclosures only. A recent attempt to expand the breadth of the private right...more

9/22/2015 - Appeals Data Retention Disclosure Personally Identifiable Information Private Right of Action Sony Third-Party Service Provider Video Privacy Protection Act VPPA

How to Avoid and Respond to a Cybersecurity Breach

In light of numerous recent data breaches, cybersecurity has emerged as an issue impacting organizations ranging from the local hardware store to the largest multi-national firms in the world. In short, no industry is immune...more

9/17/2015 - Banking Sector Breach Notification Rule CAN-SPAM Act COPPA Cyber Attacks Cyber Crimes Cyber Threats Cybersecurity Data Breach Data Protection Data Security FERPA Financial Institutions Gramm-Leach-Blilely Act Hackers Healthcare HIPAA HITECH OCR Personally Identifiable Information Privacy Laws Verizon

[Webinar] Beam It Up Safely: Navigating Data Privacy and Security in Telemedicine's Uncharted Territory - Sept. 17, 12:00pm EDT

Science fiction programs once imagined a future where a doctor on a spaceship could treat a patient on a distant planet using groundbreaking technology. The health care industry may not yet have made this giant leap, but...more

9/2/2015 - Data Privacy Data Protection Data Security Electronic Medical Records Medical Records mHealth Popular Telemedicine Webinars

Is Your Financial Institution the Next Target of a Cyber-Attack? [Video]

Not worried about cybersecurity at your financial institution? Then you are in the minority. Cyber-risk was identified as the number one worry of bank risk managers at a panel of bank chief risk officers at the American...more

6/25/2015 - Banking Sector Cyber Attacks Cybersecurity Financial Institutions Risk Assessment Risk Management Webinar

Is Your Financial Institution the Next Target of a Cyber-Attack?

In This Presentation: - Regulatory expectations for financial institutions - Risks for financial institutions - Planning to reduce risks - The Breach - Duties and responsibilities -...more

6/23/2015 - Banking Sector Cyber Attacks Cybersecurity Data Breach Enforcement FFIEC Financial Institutions Regulatory Agencies Regulatory Oversight Risk Assessment Security and Privacy Controls Strategic Planning

Lack of Typicality and Adequacy of Representation Prevents Class Certification in Health Care Data Breach

The opinion from the Philadelphia Court of Common Pleas reinforces lack of standing as a defense for companies facing data breach–related class actions. On March 25, the Philadelphia Court of Common Pleas provided...more

6/9/2015 - Class Action Data Breach Defense Strategies Electronic Medical Records Healthcare Personally Identifiable Information PHI Popular Standing Unfair or Deceptive Trade Practices

Ninth Circuit Again Clarifies that Arbitration Is Creature of Contract: Employee's Agreement to Abide by Company Manual Is...

The court’s opinion instructs that employee agreements to arbitrate may be obtained through written acknowledgments referencing company manuals. Arbitration remains a preferred forum for many employers, yet courts are...more

5/28/2015 - Arbitration Agreements Employee Rights Federal Arbitration Act Harassment Title VII

Beyond HIPAA: Connected Health Care and the Internet of Things

The U.S. Federal Trade Commission (FTC) Staff Report titled "Internet of Things: Privacy & Security in a Connected World," released in January 2015, continues to generate interest and questions about the regulation of health...more

4/15/2015 - FTC Healthcare HIPAA HITECH Internet of Things PHI Popular Security and Privacy Controls

OCIE Cybersecurity Risk Alert: Keep Your Data Close and Your Third-Party Providers Closer

On February 3, the Securities and Exchange Commission’s Office of Compliance Inspections and Examinations (OCIE) published a Risk Alert that summarizes the OCIE’s observations from its recent examinations of registered...more

2/10/2015 - Broker-Dealer Cybersecurity Data Protection Investment Adviser OCIE Popular Risk Alert SEC Third-Party Service Provider

Privacy and Data Security 2015: President Obama’s Mandate for a Strong Tight-Knit Legislative Framework

In his January 20 State of the Union address, President Obama said, “We are a strong, tight-knit family who has made it through some very, very hard times.” This statement was used as a theme for the economic initiatives set...more

1/23/2015 - Banking Sector Barack Obama Consumer Privacy Bill of Rights Cybersecurity Energy Sector FTC Information Sharing New Legislation Personal Data Notification and Protection Act Popular Student Digital Privacy Act

California Data Breaches Require Identity Protection Services

California has long set the standard for protection of its residents’ personal information. California’s constitution explicitly recognizes a right to individual privacy and California’s legislature has been on the forefront...more

1/8/2015 - Breach Notification Rule Credit Monitoring Data Breach Jerry Brown New Legislation Personally Identifiable Information

Recent Changes to California Medical Information Privacy Laws Create More Flexibility and Give Rise to Increased Enforcement

Under California Health & Safety Code (HSC) sections 1280.15(a) and (b), California licensed clinics, hospitals, home health agencies and hospices are required to prevent “unlawful or unauthorized access to, and use or...more

1/7/2015 - Health & Safety Standard Healthcare Facilities HIPAA Home Health Agencies Hospice Hospitals New Legislation Patient Confidentiality Breaches PHI Reporting Requirements

California Privacy Law Update: What to Prepare for in 2015 and Beyond

California Governor Edmund G. Brown has been busy over the last year and a half, signing several bills into law that strengthen California’s privacy laws in various areas. The bills range in scope from invasion of privacy and...more

1/5/2015 - Audio Recording COPPA Corporate Counsel Internet Privacy Invasion of Privacy Jerry Brown Minors Mobile Privacy New Legislation Photographs Popular Prior Express Consent Privacy Laws SOPIPA Students Video Recordings

Connecticut Supreme Court Allows Plaintiffs to Circumvent HIPAA’s No Private Right of Action Clause

In an opinion released on November 11, the Connecticut Supreme Court ruled on whether the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its implementing regulations preempt a common law claim for...more

11/26/2014 - Breach of Contract Class Action Data Breach Health Care Providers HIPAA Negligence Negligent Infliction of Emotional Distress Patient Confidentiality Breaches PHI Popular Private Right of Action

New Ninth Circuit Opinion Requires Companies Seeking to Enforce Arbitration to Pay 'Sirius' Attention to Contract Formation

On November 10, 2014, the U.S. Court of Appeals for the Ninth Circuit continued its recent trend of declining to enforce arbitration clauses after finding that the contracts containing those clauses were never actually formed...more

11/19/2014 - Appeals Automotive Industry Contract Formation Corporate Counsel Digital Media Mandatory Arbitration Clauses SiriusXM

Conquering Spamalot: Canada’s New Anti-Spam Legislation

Canada’s Anti-Spam Legislation (CASL), considered the most restrictive in the world, became effective on July 1, 2014. The law, which applies to American businesses, requires businesses to obtain consent before sending...more

10/24/2014 - Anti-Spam Legislation Canada CASL Spam

California Data Breaches Require Identity Protection Services (and More)

On September 30, 2014, Gov. Edmund G. Brown signed AB 1710 into law, amending existing law to impose even stricter regulation on businesses with access to personal information about California residents. California has long...more

10/9/2014 - Breach Notification Rule Data Breach Electronically Stored Information Personally Identifiable Information

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